Aging WellNCT04281264
Strength Training in Hypoxia to Improve Bone and Cardiovascular Health of Elderly
A study testing Passive Hypoxia, Normoxia Circuit Training with Elastic Bands and Hypoxia Circuit Training with Elastic Bands in people with Aging Well, run by University of Extremadura at 1 site in Spain.
Trial summary
Due to age-related effects, the bone and cardiovascular health are damaged. Physical exercise and in particular the strength training has been proposed as a fundamental tool to these pathologies, especially in the elderly. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Well
- What is being tested?
- Passive Hypoxia, Normoxia Circuit Training with Elastic Bands and Hypoxia Circuit Training with Elastic Bands
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 9 Feb 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- women and men aged 65 years or older
- no current medical condition not compatible with planned exercise
- free of illness or medication potentially affecting the bone and cardiovascular system
- estimated daily calcium intake of 1200-2000 mg/day
- consumption of no more than two alcoholic beverages per day.
Who cannot join
- participation in any other type of intervention based on physical exercise in the last 6 months in order to avoid interactions with the previous practice
- subjects have been above 1500 m during the last 3 months
- contra indications for whole-body vibration training: severe cardiovascular diseases, ocular diseases that affect the retina, neuromuscular and heart diseases, stroke, implant, bypass, stent, arthritis and other joint disease or epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Due to age-related effects, the bone and cardiovascular health are damaged. Physical exercise and in particular the strength training has been proposed as a fundamental tool to these pathologies, especially in the elderly. On the other hand, the use of normobaric hypoxia combined with exercise could have a beneficial synergistic effect on disease prevention and the quality of life of the elderly.
Therefore, the general objective of this project is to analyze the effects of different methods of strength training combined with conditions of normobaric hypoxia on the bone and cardiovascular health of the elderly. This general objective is specified in the following specific objectives:
Read more
- To analyze the effects of circuit training with elastic bands on bone mineral density and bone remodelling markers of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of circuit training with elastic bands on biochemical parameters, inflammatory, endothelial and clinical markers just like cardiovascular risk level of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of circuit training with elastic bands on body composition and functional capacity of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of whole-body vibration training on bone mineral density and bone remodelling markers of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of whole-body vibration training on biochemical parameters, inflammatory, endothelial and clinical markers just like cardiovascular risk level of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of whole-body vibration training on body composition and functional capacity of elderly, under normoxic and normobaric hypoxic conditions.
- To compare the effects of circuit training with elastic bands versus whole-body vibration training on bone and cardiovascular health of elderly, under normoxic and normobaric hypoxic conditions.
- To value the normobaric hypoxic environment efficacy on bone and cardiovascular health of elderly subjected to circuit training with elastic bands and whole-body vibration training.
We hypothesize that bone and cardiovascular health will improve in the participants subjected to both resistance training, but greater improved may be found when these protocol are combined with normobaric hypoxia.
Read the detailed description
Participants:
Various associations of pensioners will be contacted as well as the university of seniors of the University of Extremadura to recruit volunteer participants. Total sample size will be 120 people, being this calculated to obtaining a statistical power of 90%, calculated with a margin of error of 5% and a mean difference of 10% in the study variables Design All interventions will be performed during 24 weeks, with a frequency training of 3 days per weeks; sessions will be scheduled with at least one day of rest in between for optimal recovery. All patients were assessed at two time points: at baseline before intervention (Pre) and reassessed 7 days after the last session (Post). Participants will be instructed to continue with their normal daily activities, diet and caloric and calcium intake for the entire duration of the study.
Interventions:
During several times of the session in each intervention, oxygen saturation (SpO2) will be controlled using a finger pulse-oximeter (Konica Minolta, Japan) and heart rate (HR) using a heart rate monitor (Polar team 2, Polar, Finland) to know the physiological challenge posed on the participants during the exposure.
PASSIVE HYPOXIA:
During 30 minutes of session, the participants will be performed an intellectual activity while they will be exposed to normobaric hypoxic conditions in a hypoxic chamber (CAT 310, Lousiville, Colorado). They will inspire oxygen fraction (FiO2) set to 16.1% (0.16) in order to simulate an altitude of 2500m above sea level.
NORMOXIA CIRCUIT TRAINING WITH ELASTIC BANDS Each training sessions will consist of a circuit training, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit that will be composed by 3 sets of 12-15 repetitions of nine different exercises. Six exercises will be performed using elastic resistance bands (ERS; TheraBand®): chest press, row, glute kickbacks, front and side raises, standing bíceps curls and triceps kickbacks. To provide resistance with ERB, elastic bands with resistance ranging from light to very heavy loading (colors: yellow-gold) were used. ERBs were 2 meters, but the actual length used (grip on ERBs and distance to anchor point) was fine tuned for each subject in each exercise to find the correct resistance. When necessary to increase loading, two or more bands were combined. Bands were prestretched and never elongated more than 300% of resting length, as recommended by the manufacturer. Two additional exercise will be developed with kettlebell (KB): squat with 6 kg or increase loading until 10 kg; and hip trust, increase loading with support of a foot alone or with additional loading (KB of 5 or 10 kg). Finally, the subjects will keep a plank position during 15-20 seconds.
Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. In order to blind subjects to altitude, the system will be run with normoxic airflow into the chamber (up to 1000 l/min) and will produce the same audible noise as in the hypoxic condition. Subjects will inspire FiO2 of 21.0% (0.21) to simulate an altitude of 459 m above sea level. Furthermore, all systems will be covered with fabric to prevent participants from visually identifying the normoxic or hypoxic conditions. FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States).
HYPOXIA CIRCUIT TRAINING WITH ELASTIC BANDS Each training sessions will consist of a circuit training, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit, that will be composed by 3 sets of 12-15 repetitions of nine different exercises. Six exercises will be performed using elastic resistance bands (ERS; TheraBand®): chest press, row, glute kickbacks, front and side raises, standing bíceps curls and triceps kickbacks. To provide resistance with ERB, elastic bands with resistance ranging from light to very heavy loading (colors: yellow-gold) were used. ERBs were 2 meters, but the actual length used (grip on ERBs and distance to anchor point) was fine tuned for each subject in each exercise to find the correct resistance. When necessary to increase loading, two or more bands were combined. Bands were prestretched and never elongated more than 300% of resting length, as recommended by the manufacturer. Two additional exercise will be developed with kettlebell (KB): squat with 6 kg or increase loading until 10 kg; and hip trust, increase loading with support of a foot alone or with additional loading (KB of 5 or 10 kg). Finally, the subjects will keep a plank position during 15-20 seconds Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. Participants will inspire a fraction of inspired oxygen (FiO2) of 16.1% (0.16) to simulate an altitude of 2500 m above sea level; FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States).
NORMOXIA WHOLE-BODY VIBRATION The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the session.
Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performance, with the soles of both feet remained in contact with the platform:
- Stand with feet side-by-side on the board, which produced lateral oscillations of the whole body. During the vibration training sessions, the subjects will be barefoot to eliminate any damping of the vibration caused by footwear. The angle of flexion of the knees during the vibration exercise will be set at 60°.
- Begin with the feet placed perpendicular to the midline axis of the platform, with a foot positioned slightly ahead of the other foot. Lift the toes of the one foot and the heel of the other foot 4 mm above the surface of the platform. Bend the knees and maintain a 45°knee angle. Keep the back and head straight. Alternate legs.
- Front foot 4 mm above the surface of the platform and back foot on ground, front knee angle 90°. Alternate legs
- Lay down on the ground, with the knees bent and feet flat on the platform. Keep the arms at your side with your palms down. Lift the hips off the ground until the knees, hips and shoulders form a straight line. Hold your bridged position.
Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. In order to blind subjects to altitude, the system will be run with normoxic airflow into the chamber (up to 1000 l/min) and will produce the same audible noise as in the hypoxic condition. Subjects will inspire FiO2 of 21.0% (0.21) to simulate an altitude of 459 m above sea level. Furthermore, all systems will be covered with fabric to prevent participants from visually identifying the normoxic or hypoxic conditions. FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States).
HYPOXIA WHOLE-BODY VIBRATION The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the session.
Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performance, with the soles of both feet remained in contact with the platform:
- Stand with feet side-by-side on the board, which produced lateral oscillations of the whole body. During the vibration training sessions, the subjects will be barefoot to eliminate any damping of the vibration caused by footwear. The angle of flexion of the knees during the vibration exercise will be set at 60°.
- Begin with the feet placed perpendicular to the midline axis of the platform, with a foot positioned slightly ahead of the other foot. Lift the toes of the one-foot and the heel of the other foot 4 mm above the surface of the platform. Bend the knees and maintain a 45°knee angle. Keep the back and head straight. Alternate legs.
- Front foot 4 mm above the surface of the platform and back foot on ground, front knee angle 90°. Alternate legs
- Lay down on the ground, with the knees bent and feet flat on the platform. Keep the arms at your side with your palms down. Lift the hips off the ground until the knees, hips and shoulders form a straight line. Hold your bridged position.
Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. Participants will inspire a fraction of inspired oxygen (FiO2) of 16.1% (0.16) to simulate an altitude of 2500 m above sea level; FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States).
Statistical Analysis Statistical analyses will be performed using the statistical analysis package SPSS v.20 (IBM, New York, United States). Data will be expressed as median and standard deviation. Kolmogorov-Smirnov tests will be conducted to show the distribution of the studied variables and Levene's test for homogeneity of variance. Repeated measure ANOVA will be used to compare the response of each variable, considering the sex and age as covariate. The p < 0.05 criterion was used for establishing statistical significance. Effect size (Cohen, 1992) will be also calculated for all variables, considering the magnitude of change as small (0.2), moderate (0.5) or large (0.8).
- Conditions
- Aging Well
- Being tested
- Passive Hypoxia, Normoxia Circuit Training with Elastic Bands, Hypoxia Circuit Training with Elastic Bands, Normoxia Vibration, Hypoxia Vibration
- Keywords
- bone mineral density, healthy aging, resistance training, normobaric hypoxia, cardiovascular health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive HypoxiaBehavioural
During 30 minutes of session, the participants will perform an intellectual activity while they will be exposed to normobaric hypoxic conditions in a hypoxic chamber (CAT 310, Lousiville, Colorado). They will inspire oxygen fraction (FiO2) set to 16.1% (0.16)
Normoxia Circuit Training with Elastic BandsBehavioural
Each training sessions will consist of a circuit training with elastic bands, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit that will be composed by 3 sets of 12-15 repetitions of nine different exercises.
Subjects will inspire FiO2 of 21.0% (0.21)
Hypoxia Circuit Training with Elastic BandsBehavioural
Each training sessions will consist of a circuit training with elastic bands, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit that will be composed by 3 sets of 12-15 repetitions of nine different exercises.
Subjects will inspire FiO2 of 21.0% (0.21)
Normoxia VibrationBehavioural
The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles.
Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performed on platform.
Subjects will inspire FiO2 of 21.0% (0.21)
Hypoxia VibrationBehavioural
The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles.
Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performance on the platform.
Participants will inspire a fraction of inspired oxygen (FiO2) of 16.1% (0.16)
| Study group | Role | What they receive |
|---|---|---|
| NorCON | No intervention | Normoxia Control Group |
| HypCON | Active comparator | Hypoxia Control Group Receives: Behavioral: Passive Hypoxia |
| NorCIR | Placebo comparator | Normoxia Circuit Training with Elastic Bands Group Receives: Behavioral: Normoxia Circuit Training with Elastic Bands |
| HypCIR | Experimental | Hypoxia Circuit Training with Elastic Bands Group Receives: Behavioral: Hypoxia Circuit Training with Elastic Bands |
| NorVIB | Placebo comparator | Normoxia Whole-body Vibration Training Group Receives: Behavioral: Normoxia Vibration |
| HypVIB | Experimental | Hypoxia Whole-body Vibration Training Group Receives: Behavioral: Hypoxia Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Life Quality at 24 weeks
SF-36 questionnaire will be used to know the life quality
Measured: Through study completion, an average of 24 weeks
Change from Baseline Risk of Fall at 24 weeks
Risk of fall will be evaluated through Fall Efficacy Scale-International (FES-I)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Blood Pressure at 24 weeks
Blood pressure (mmHg) will be measured with sphygmomanometer
Measured: Through study completion, an average of 24 weeks
Change from Baseline Cardiovascular Evaluation at 24 weeks
Arm-ankle index and pulse wave velocity will be measured using ultrasound Doppler technique
Measured: Through study completion, an average of 24 weeks
Change from Baseline Cardiovascular Risk at 24 weeks
Based on the following factors: age, sex, smoking, total cholesterol, HDL cholesterol, systolic blood pressure and diabetes, cardiovascular risk will be determined. This method was already described in the FRESCO study
Measured: Through study completion, an average of 24 weeks
Change from Baseline Weight at 24 weeks
Weight (kilograms) will measure following standard procedures
Measured: Through study completion, an average of 24 weeks
Change from Baseline Height at 24 weeks
Height (meters) will measure following standard procedures
Measured: Through study completion, an average of 24 weeks
Change from Baseline Body Mass Index at 24 weeks
Weight and Height will be combined to report body mass index (BMI) in kg/m^2
Measured: Through study completion, an average of 24 weeks
Change from Baseline Waist-Hip Ratio at 24 weeks
Waist and hip diameter (centimeters) will be combined to report Waist-Hip Ratio
Measured: Through study completion, an average of 24 weeks
Change from Baseline Body Composition at 24 weeks
Body composition variables such as percentage fat and lean fat mass (percentage) will be obtain using dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States).
Measured: Through study completion, an average of 24 weeks
Change from Baseline Bone Mineral Density at 24 weeks
Bone mineral density (g/cm-2) of whole body and proximal femur region will be calculated from obtained data of dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Osteoporosis/Osteopenia Prevalence at 24 weeks
T-score of whole body and proximal femur region will be calculated from obtained data of dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Bone Mineral Content at 24 weeks
Bone mineral content (g) of whole body and proximal femur region will be calculated from obtained data of dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Biochemical Parameters at 24 weeks
Standard biochemical analysis (HDL, LDL and Total Cholesterol, Triglycerides and Glucose in mg/dL) will be obtained of blood samples, through a clinical chemistry analyzer (Spotchem, Arkray Factory, Germany)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Bone Remodelling Markers at 24 weeks
Bone remodelling (VEGF and SDF-1 in mg/dL) markers will be analyzed by ELISA technique.
Measured: Through study completion, an average of 24 weeks
Change from Baseline Inflammatory Markers at 24 weeks
Inflammatory (C-reactive protein, IL-2, IL-4, IL-6 and TNFa in mg/dL) markers will be analyzed by ELISA technique.
Measured: Through study completion, an average of 24 weeks
Change from Baseline Endothelial Markers at 24 weeks
Endothelial (ICAM-1 and VCAM-1 in mg/dL) markers will be analyzed by ELISA technique.
Measured: Through study completion, an average of 24 weeks
Change from Baseline Lower Limb Strength at 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Lower limb strength will be tested by Chair stand Test (repetitions)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Upper Limb Strength at 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Upper limb strength will be tested by Arm curl Test (repetitions)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Lower Limb Flexibility at 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Lower limb flexibility will be tested by Chair sit and reach Test (centimeters)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Upper Limb Flexibility at 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Upper limb flexibility will be tested by Back scratch Test (centimeters)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Endurance at 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Endurance will be tested by 6 min. walk Test (meters)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Agility at 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Agility will be tested by 8ft Up and Go Test (seconds).
Measured: Through study completion, an average of 24 weeks
Change from Baseline Core muscle strength at 24 weeks
Core muscle strength will be tested by plank test (seconds)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Grip strength at 24 weeks
Grip strength will be tested using an Handgrip (kilograms)
Measured: Through study completion, an average of 24 weeks
Change from Baseline Balance at 24 weeks
Balance will be tested by single leg stance test (seconds)
Measured: Through study completion, an average of 24 weeks
Secondary outcomes (3)
Socio-Demographic Data
A general questionnaire was administered to collect medical and demographic data to check the inclusion/exclusion criteria.
Measured: Baseline
Change from Baseline Calcium Intake at 24 weeks
Calcium intake (mg/day) will be estimated using a food frequency questionnaire
Measured: Through study completion, an average of 24 weeks
Change from Baseline Physical Activity Level at 24 weeks
The bone-specific physical activity questionnaire (B-PAQ; score) will be used to assess the physical activity level of the participants.
Measured: Through study completion, an average of 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start9 Feb 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Aging WellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized control trial, in which the experimental sample will be divided into 6 groups where different intervention programs will be performed
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Timón, PhD, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281264
- Sponsor's protocol ID
- IB18010
- Status last verified
- Jul 2021
- First submitted
- 14 Feb 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhella PS, Hastings JL, Fujimoto N, Shibata S, Carrick-Ranson G, Palmer MD, Boyd KN, Adams-Huet B, Levine BD. Impact of lifelong exercise "dose" on left ventricular compliance and distensibility. J Am Coll Cardiol. 2014 Sep 23;64(12):1257-66. doi: 10.1016/j.jacc.2014.03.062.
PubMed 25236519Bliuc D, Nguyen ND, Milch VE, Nguyen TV, Eisman JA, Center JR. Mortality risk associated with low-trauma osteoporotic fracture and subsequent fracture in men and women. JAMA. 2009 Feb 4;301(5):513-21. doi: 10.1001/jama.2009.50.
PubMed 19190316Bogaerts A, Delecluse C, Boonen S, Claessens AL, Milisen K, Verschueren SM. Changes in balance, functional performance and fall risk following whole body vibration training and vitamin D supplementation in institutionalized elderly women. A 6 month randomized controlled trial. Gait Posture. 2011 Mar;33(3):466-72. doi: 10.1016/j.gaitpost.2010.12.027. Epub 2011 Jan 20.
PubMed 21256028Buckinx F, Beaudart C, Maquet D, Demonceau M, Crielaard JM, Reginster JY, Bruyere O. Evaluation of the impact of 6-month training by whole body vibration on the risk of falls among nursing home residents, observed over a 12-month period: a single blind, randomized controlled trial. Aging Clin Exp Res. 2014 Aug;26(4):369-76. doi: 10.1007/s40520-014-0197-z. Epub 2014 Jan 28.
PubMed 24469903Burghardt AJ, Buie HR, Laib A, Majumdar S, Boyd SK. Reproducibility of direct quantitative measures of cortical bone microarchitecture of the distal radius and tibia by HR-pQCT. Bone. 2010 Sep;47(3):519-28. doi: 10.1016/j.bone.2010.05.034. Epub 2010 May 31.
PubMed 20561906Celis-Morales CA, Welsh P, Lyall DM, Steell L, Petermann F, Anderson J, Iliodromiti S, Sillars A, Graham N, Mackay DF, Pell JP, Gill JMR, Sattar N, Gray SR. Associations of grip strength with cardiovascular, respiratory, and cancer outcomes and all cause mortality: prospective cohort study of half a million UK Biobank participants. BMJ. 2018 May 8;361:k1651. doi: 10.1136/bmj.k1651.
PubMed 29739772Cenzer IS, Tang V, Boscardin WJ, Smith AK, Ritchie C, Wallhagen MI, Espaldon R, Covinsky KE. One-Year Mortality After Hip Fracture: Development and Validation of a Prognostic Index. J Am Geriatr Soc. 2016 Sep;64(9):1863-8. doi: 10.1111/jgs.14237. Epub 2016 Jun 13.
PubMed 27295578Chan DA, Sutphin PD, Denko NC, Giaccia AJ. Role of prolyl hydroxylation in oncogenically stabilized hypoxia-inducible factor-1alpha. J Biol Chem. 2002 Oct 18;277(42):40112-7. doi: 10.1074/jbc.M206922200. Epub 2002 Aug 16.
PubMed 12186875Cummings SR, Melton LJ. Epidemiology and outcomes of osteoporotic fractures. Lancet. 2002 May 18;359(9319):1761-7. doi: 10.1016/S0140-6736(02)08657-9.
PubMed 12049882Delecluse C, Roelants M, Verschueren S. Strength increase after whole-body vibration compared with resistance training. Med Sci Sports Exerc. 2003 Jun;35(6):1033-41. doi: 10.1249/01.MSS.0000069752.96438.B0.
PubMed 12783053Dreimuller N, Schlicht KF, Wagner S, Peetz D, Borysenko L, Hiemke C, Lieb K, Tadic A. Early reactions of brain-derived neurotrophic factor in plasma (pBDNF) and outcome to acute antidepressant treatment in patients with Major Depression. Neuropharmacology. 2012 Jan;62(1):264-9. doi: 10.1016/j.neuropharm.2011.07.017. Epub 2011 Jul 22.
PubMed 21803060Erickson KI, Voss MW, Prakash RS, Basak C, Szabo A, Chaddock L, Kim JS, Heo S, Alves H, White SM, Wojcicki TR, Mailey E, Vieira VJ, Martin SA, Pence BD, Woods JA, McAuley E, Kramer AF. Exercise training increases size of hippocampus and improves memory. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3017-22. doi: 10.1073/pnas.1015950108. Epub 2011 Jan 31.
PubMed 21282661Fratini A, Bonci T, Bull AM. Whole Body Vibration Treatments in Postmenopausal Women Can Improve Bone Mineral Density: Results of a Stimulus Focussed Meta-Analysis. PLoS One. 2016 Dec 1;11(12):e0166774. doi: 10.1371/journal.pone.0166774. eCollection 2016.
PubMed 27907000Gianoudis J, Bailey CA, Ebeling PR, Nowson CA, Sanders KM, Hill K, Daly RM. Effects of a targeted multimodal exercise program incorporating high-speed power training on falls and fracture risk factors in older adults: a community-based randomized controlled trial. J Bone Miner Res. 2014 Jan;29(1):182-91. doi: 10.1002/jbmr.2014.
PubMed 23775701Gonzalez-Aguero A, Vicente-Rodriguez G, Gomez-Cabello A, Casajus JA. Cortical and trabecular bone at the radius and tibia in male and female adolescents with Down syndrome: a peripheral quantitative computed tomography (pQCT) study. Osteoporos Int. 2013 Mar;24(3):1035-44. doi: 10.1007/s00198-012-2041-7. Epub 2012 Jun 9.
PubMed 22684498
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training in Hypoxia to Improve Bone and Cardiovascular Health of Elderly
- ClinicalTrials.gov ID
- NCT04281264
- Acronym / sponsor ID
- IB18010
- Conditions
- Aging Well
- Keywords
- bone mineral density, healthy aging, resistance training, normobaric hypoxia, cardiovascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 9 Feb 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to age-related effects, the bone and cardiovascular health are damaged. Physical exercise and in particular the strength training has been proposed as a fundamental tool to these pathologies, especially in the elderly. On the other hand, the use of normobaric hypoxia combined with exercise could have a beneficial synergistic effect on disease prevention and the quality of life of the elderly.
Therefore, the general objective of this project is to analyze the effects of different methods of strength training combined with conditions of normobaric hypoxia on the bone and cardiovascular health of the elderly. This general objective is specified in the following specific objectives:
- To analyze the effects of circuit training with elastic bands on bone mineral density and bone remodelling markers of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of circuit training with elastic bands on biochemical parameters, inflammatory, endothelial and clinical markers just like cardiovascular risk level of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of circuit training with elastic bands on body composition and functional capacity of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of whole-body vibration training on bone mineral density and bone remodelling markers of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of whole-body vibration training on biochemical parameters, inflammatory, endothelial and clinical markers just like cardiovascular risk level of elderly, under normoxic and normobaric hypoxic conditions.
- To analyze the effects of whole-body vibration training on body composition and functional capacity of elderly, under normoxic and normobaric hypoxic conditions.
- To compare the effects of circuit training with elastic bands versus whole-body vibration training on bone and cardiovascular health of elderly, under normoxic and normobaric hypoxic conditions.
- To value the normobaric hypoxic environment efficacy on bone and cardiovascular health of elderly subjected to circuit training with elastic bands and whole-body vibration training.
We hypothesize that bone and cardiovascular health will improve in the participants subjected to both resistance training, but greater improved may be found when these protocol are combined with normobaric hypoxia.
Detailed description
Participants:
Various associations of pensioners will be contacted as well as the university of seniors of the University of Extremadura to recruit volunteer participants. Total sample size will be 120 people, being this calculated to obtaining a statistical power of 90%, calculated with a margin of error of 5% and a mean difference of 10% in the study variables Design All interventions will be performed during 24 weeks, with a frequency training of 3 days per weeks; sessions will be scheduled with at least one day of rest in between for optimal recovery. All patients were assessed at two time points: at baseline before intervention (Pre) and reassessed 7 days after the last session (Post). Participants will be instructed to continue with their normal daily activities, diet and caloric and calcium intake for the entire duration of the study.
Interventions:
During several times of the session in each intervention, oxygen saturation (SpO2) will be controlled using a finger pulse-oximeter (Konica Minolta, Japan) and heart rate (HR) using a heart rate monitor (Polar team 2, Polar, Finland) to know the physiological challenge posed on the participants during the exposure.
PASSIVE HYPOXIA:
During 30 minutes of session, the participants will be performed an intellectual activity while they will be exposed to normobaric hypoxic conditions in a hypoxic chamber (CAT 310, Lousiville, Colorado). They will inspire oxygen fraction (FiO2) set to 16.1% (0.16) in order to simulate an altitude of 2500m above sea level.
NORMOXIA CIRCUIT TRAINING WITH ELASTIC BANDS Each training sessions will consist of a circuit training, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit that will be composed by 3 sets of 12-15 repetitions of nine different exercises. Six exercises will be performed using elastic resistance bands (ERS; TheraBand®): chest press, row, glute kickbacks, front and side raises, standing bíceps curls and triceps kickbacks. To provide resistance with ERB, elastic bands with resistance ranging from light to very heavy loading (colors: yellow-gold) were used. ERBs were 2 meters, but the actual length used (grip on ERBs and distance to anchor point) was fine tuned for each subject in each exercise to find the correct resistance. When necessary to increase loading, two or more bands were combined. Bands were prestretched and never elongated more than 300% of resting length, as recommended by the manufacturer. Two additional exercise will be developed with kettlebell (KB): squat with 6 kg or increase loading until 10 kg; and hip trust, increase loading with support of a foot alone or with additional loading (KB of 5 or 10 kg). Finally, the subjects will keep a plank position during 15-20 seconds.
Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. In order to blind subjects to altitude, the system will be run with normoxic airflow into the chamber (up to 1000 l/min) and will produce the same audible noise as in the hypoxic condition. Subjects will inspire FiO2 of 21.0% (0.21) to simulate an altitude of 459 m above sea level. Furthermore, all systems will be covered with fabric to prevent participants from visually identifying the normoxic or hypoxic conditions. FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States).
HYPOXIA CIRCUIT TRAINING WITH ELASTIC BANDS Each training sessions will consist of a circuit training, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit, that will be composed by 3 sets of 12-15 repetitions of nine different exercises. Six exercises will be performed using elastic resistance bands (ERS; TheraBand®): chest press, row, glute kickbacks, front and side raises, standing bíceps curls and triceps kickbacks. To provide resistance with ERB, elastic bands with resistance ranging from light to very heavy loading (colors: yellow-gold) were used. ERBs were 2 meters, but the actual length used (grip on ERBs and distance to anchor point) was fine tuned for each subject in each exercise to find the correct resistance. When necessary to increase loading, two or more bands were combined. Bands were prestretched and never elongated more than 300% of resting length, as recommended by the manufacturer. Two additional exercise will be developed with kettlebell (KB): squat with 6 kg or increase loading until 10 kg; and hip trust, increase loading with support of a foot alone or with additional loading (KB of 5 or 10 kg). Finally, the subjects will keep a plank position during 15-20 seconds Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. Participants will inspire a fraction of inspired oxygen (FiO2) of 16.1% (0.16) to simulate an altitude of 2500 m above sea level; FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States).
NORMOXIA WHOLE-BODY VIBRATION The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the session.
Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performance, with the soles of both feet remained in contact with the platform:
- Stand with feet side-by-side on the board, which produced lateral oscillations of the whole body. During the vibration training sessions, the subjects will be barefoot to eliminate any damping of the vibration caused by footwear. The angle of flexion of the knees during the vibration exercise will be set at 60°.
- Begin with the feet placed perpendicular to the midline axis of the platform, with a foot positioned slightly ahead of the other foot. Lift the toes of the one foot and the heel of the other foot 4 mm above the surface of the platform. Bend the knees and maintain a 45°knee angle. Keep the back and head straight. Alternate legs.
- Front foot 4 mm above the surface of the platform and back foot on ground, front knee angle 90°. Alternate legs
- Lay down on the ground, with the knees bent and feet flat on the platform. Keep the arms at your side with your palms down. Lift the hips off the ground until the knees, hips and shoulders form a straight line. Hold your bridged position.
Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. In order to blind subjects to altitude, the system will be run with normoxic airflow into the chamber (up to 1000 l/min) and will produce the same audible noise as in the hypoxic condition. Subjects will inspire FiO2 of 21.0% (0.21) to simulate an altitude of 459 m above sea level. Furthermore, all systems will be covered with fabric to prevent participants from visually identifying the normoxic or hypoxic conditions. FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States).
HYPOXIA WHOLE-BODY VIBRATION The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the session.
Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performance, with the soles of both feet remained in contact with the platform:
- Stand with feet side-by-side on the board, which produced lateral oscillations of the whole body. During the vibration training sessions, the subjects will be barefoot to eliminate any damping of the vibration caused by footwear. The angle of flexion of the knees during the vibration exercise will be set at 60°.
- Begin with the feet placed perpendicular to the midline axis of the platform, with a foot positioned slightly ahead of the other foot. Lift the toes of the one-foot and the heel of the other foot 4 mm above the surface of the platform. Bend the knees and maintain a 45°knee angle. Keep the back and head straight. Alternate legs.
- Front foot 4 mm above the surface of the platform and back foot on ground, front knee angle 90°. Alternate legs
- Lay down on the ground, with the knees bent and feet flat on the platform. Keep the arms at your side with your palms down. Lift the hips off the ground until the knees, hips and shoulders form a straight line. Hold your bridged position.
Training will take place in a hypoxia chamber (CAT 310, Lousiville, Colorado, United States) will place in the laboratory. Participants will inspire a fraction of inspired oxygen (FiO2) of 16.1% (0.16) to simulate an altitude of 2500 m above sea level; FiO2 will be controlled regularly with an electronic device (HANDIC,Maxtec, Salt Lake City, Utah, United States).
Statistical Analysis Statistical analyses will be performed using the statistical analysis package SPSS v.20 (IBM, New York, United States). Data will be expressed as median and standard deviation. Kolmogorov-Smirnov tests will be conducted to show the distribution of the studied variables and Levene's test for homogeneity of variance. Repeated measure ANOVA will be used to compare the response of each variable, considering the sex and age as covariate. The p < 0.05 criterion was used for establishing statistical significance. Effect size (Cohen, 1992) will be also calculated for all variables, considering the magnitude of change as small (0.2), moderate (0.5) or large (0.8).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Randomized control trial, in which the experimental sample will be divided into 6 groups where different intervention programs will be performed
| Arm | Type | Receives |
|---|---|---|
| NorCON | No intervention | –Normoxia Control Group |
| HypCON | Active comparator | Behavioral: Passive HypoxiaHypoxia Control Group |
| NorCIR | Placebo comparator | Behavioral: Normoxia Circuit Training with Elastic BandsNormoxia Circuit Training with Elastic Bands Group |
| HypCIR | Experimental | Behavioral: Hypoxia Circuit Training with Elastic BandsHypoxia Circuit Training with Elastic Bands Group |
| NorVIB | Placebo comparator | Behavioral: Normoxia VibrationNormoxia Whole-body Vibration Training Group |
| HypVIB | Experimental | Behavioral: Hypoxia VibrationHypoxia Whole-body Vibration Training Group |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- women and men aged 65 years or older
- no current medical condition not compatible with planned exercise
- free of illness or medication potentially affecting the bone and cardiovascular system
- estimated daily calcium intake of 1200-2000 mg/day
- consumption of no more than two alcoholic beverages per day.
Key exclusion criteria (3 listed)
- participation in any other type of intervention based on physical exercise in the last 6 months in order to avoid interactions with the previous practice
- subjects have been above 1500 m during the last 3 months
- contra indications for whole-body vibration training: severe cardiovascular diseases, ocular diseases that affect the retina, neuromuscular and heart diseases, stroke, implant, bypass, stent, arthritis and other joint disease or epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive HypoxiaDuring 30 minutes of session, the participants will perform an intellectual activity while they will be exposed to normobaric hypoxic conditions in a hypoxic chamber (CAT 310, Lousiville, Colorado). They will inspire oxygen fraction (FiO2) set to 16.1% (0.16) | Behavioural | HypCON |
| Normoxia Circuit Training with Elastic BandsEach training sessions will consist of a circuit training with elastic bands, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit that will be composed by 3 sets of 12-15 repetitions of nine different exercises. Subjects will inspire FiO2 of 21.0% (0.21) | Behavioural | NorCIR |
| Hypoxia Circuit Training with Elastic BandsEach training sessions will consist of a circuit training with elastic bands, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit that will be composed by 3 sets of 12-15 repetitions of nine different exercises. Subjects will inspire FiO2 of 21.0% (0.21) | Behavioural | HypCIR |
| Normoxia VibrationThe subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles. Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performed on platform. Subjects will inspire FiO2 of 21.0% (0.21) | Behavioural | NorVIB |
| Hypoxia VibrationThe subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles. Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performance on the platform. Participants will inspire a fraction of inspired oxygen (FiO2) of 16.1% (0.16) | Behavioural | HypVIB |
Primary outcome
Change from Baseline Life Quality at 24 weeks
Time frame: Through study completion, an average of 24 weeks
SF-36 questionnaire will be used to know the life quality
Change from Baseline Risk of Fall at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Risk of fall will be evaluated through Fall Efficacy Scale-International (FES-I)
Change from Baseline Blood Pressure at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Blood pressure (mmHg) will be measured with sphygmomanometer
Change from Baseline Cardiovascular Evaluation at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Arm-ankle index and pulse wave velocity will be measured using ultrasound Doppler technique
Change from Baseline Cardiovascular Risk at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Based on the following factors: age, sex, smoking, total cholesterol, HDL cholesterol, systolic blood pressure and diabetes, cardiovascular risk will be determined. This method was already described in the FRESCO study
Change from Baseline Weight at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Weight (kilograms) will measure following standard procedures
Change from Baseline Height at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Height (meters) will measure following standard procedures
Change from Baseline Body Mass Index at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Weight and Height will be combined to report body mass index (BMI) in kg/m^2
Change from Baseline Waist-Hip Ratio at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Waist and hip diameter (centimeters) will be combined to report Waist-Hip Ratio
Change from Baseline Body Composition at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Body composition variables such as percentage fat and lean fat mass (percentage) will be obtain using dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States).
Change from Baseline Bone Mineral Density at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Bone mineral density (g/cm-2) of whole body and proximal femur region will be calculated from obtained data of dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States)
Change from Baseline Osteoporosis/Osteopenia Prevalence at 24 weeks
Time frame: Through study completion, an average of 24 weeks
T-score of whole body and proximal femur region will be calculated from obtained data of dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States)
Change from Baseline Bone Mineral Content at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Bone mineral content (g) of whole body and proximal femur region will be calculated from obtained data of dual-energy X-ray absorptiometry (DXA,Norland Excell Plus; Norland Inc., Fort Atkinson, United States)
Change from Baseline Biochemical Parameters at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Standard biochemical analysis (HDL, LDL and Total Cholesterol, Triglycerides and Glucose in mg/dL) will be obtained of blood samples, through a clinical chemistry analyzer (Spotchem, Arkray Factory, Germany)
Change from Baseline Bone Remodelling Markers at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Bone remodelling (VEGF and SDF-1 in mg/dL) markers will be analyzed by ELISA technique.
Change from Baseline Inflammatory Markers at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Inflammatory (C-reactive protein, IL-2, IL-4, IL-6 and TNFa in mg/dL) markers will be analyzed by ELISA technique.
Change from Baseline Endothelial Markers at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Endothelial (ICAM-1 and VCAM-1 in mg/dL) markers will be analyzed by ELISA technique.
Change from Baseline Lower Limb Strength at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Lower limb strength will be tested by Chair stand Test (repetitions)
Change from Baseline Upper Limb Strength at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Upper limb strength will be tested by Arm curl Test (repetitions)
Change from Baseline Lower Limb Flexibility at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Lower limb flexibility will be tested by Chair sit and reach Test (centimeters)
Change from Baseline Upper Limb Flexibility at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Upper limb flexibility will be tested by Back scratch Test (centimeters)
Change from Baseline Endurance at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Endurance will be tested by 6 min. walk Test (meters)
Change from Baseline Agility at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Senior Fitness Test battery will be used to know of physical condition of elderly. Agility will be tested by 8ft Up and Go Test (seconds).
Change from Baseline Core muscle strength at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Core muscle strength will be tested by plank test (seconds)
Change from Baseline Grip strength at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Grip strength will be tested using an Handgrip (kilograms)
Change from Baseline Balance at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Balance will be tested by single leg stance test (seconds)
3 secondary outcomes
Socio-Demographic Data
Time frame: Baseline
Change from Baseline Calcium Intake at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Change from Baseline Physical Activity Level at 24 weeks
Time frame: Through study completion, an average of 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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- Background: PubMed 21256028Bogaerts A, Delecluse C, Boonen S, Claessens AL, Milisen K, Verschueren SM. Changes in balance, functional performance and fall risk following whole body vibration training and vitamin D supplementation in institutionalized elderly women. A 6 month randomized controlled trial. Gait Posture. 2011 Mar;33(3):466-72. doi: 10.1016/j.gaitpost.2010.12.027. Epub 2011 Jan 20.
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- Background: PubMed 20561906Burghardt AJ, Buie HR, Laib A, Majumdar S, Boyd SK. Reproducibility of direct quantitative measures of cortical bone microarchitecture of the distal radius and tibia by HR-pQCT. Bone. 2010 Sep;47(3):519-28. doi: 10.1016/j.bone.2010.05.034. Epub 2010 May 31.
- Background: PubMed 29739772Celis-Morales CA, Welsh P, Lyall DM, Steell L, Petermann F, Anderson J, Iliodromiti S, Sillars A, Graham N, Mackay DF, Pell JP, Gill JMR, Sattar N, Gray SR. Associations of grip strength with cardiovascular, respiratory, and cancer outcomes and all cause mortality: prospective cohort study of half a million UK Biobank participants. BMJ. 2018 May 8;361:k1651. doi: 10.1136/bmj.k1651.
- Background: PubMed 27295578Cenzer IS, Tang V, Boscardin WJ, Smith AK, Ritchie C, Wallhagen MI, Espaldon R, Covinsky KE. One-Year Mortality After Hip Fracture: Development and Validation of a Prognostic Index. J Am Geriatr Soc. 2016 Sep;64(9):1863-8. doi: 10.1111/jgs.14237. Epub 2016 Jun 13.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Hypoxia, Normoxia Circuit Training with Elastic Bands and Hypoxia Circuit Training with Elastic Bands in people with Aging Well, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Life Quality at 24 weeks (time frame: Through study completion, an average of 24 weeks). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04281264, which also lists 53 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.