SarcopeniaNCT05220670
Sarcopenia, Active Aging and Oral Microbiota. Effects of HIIT in Older Adults
A study testing HIIT and MICT in people with Sarcopenia, run by University of Jaén at 1 site in Spain.
Trial summary
To analyze the effects of a high intensity exercises program by intervals on sarcopenia, active aging and oral microbiota in older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- HIIT and MICT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2021to 11 Apr 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- SARC-F ≥4 or handgrip strength <16 kg for women and < 27 kg for men.
- Not being afflicted by any condition preventing physical activity.
- Not being engaged in regular physical activity >20 minutes and >3 days/week.
- Being able to communicate without difficulty.
- Being able to read and understand the informed consent form as well as the goals of the study.
Who cannot join
- Acute or terminal illness.
- Unstable cardiovascular conditions.
- Conditions or medical treatments affecting the normal production of saliva (i.e. autoimmune disorders such as Sjögren's syndrome or medications like anxiolytics or antidepressants).
- Being or having been medicated with antibiotics up to one month prior to the taking of samples.
- Alcohol abuse or regular drug abuse.
- Severe visual or auditory impairment.
- Being involved in a different research group with the potential to interfere in our results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sarcopenia, Active Aging and Oral Microbiota in Older Adults. Effects of a High Intensity Exercises Program by Intervals
To analyze the effects of a high intensity exercises program by intervals on sarcopenia, active aging and oral microbiota in older adults.
Read the detailed description
All participants will be advised to lead healthy lifestyle habits according to the recommendations of the "Plan for the Promotion of Physical Activity and Balanced Eating of the Junta de Andalucía" http://www.juntadeandalucia.es/educacion/webporta/ishareservlet/content/86cf9950-abaa-403b-9fc3 9bc5ecae4614. A submaximal stress test will be performed at the beginning and end of the intervention. Before the test, the participants will become familiar with the measuring instrument with a warm-up that allowed them a gain in understanding the gear system. The test will start with a pedaling cadence of 50 revolutions, with an output power of 0 W, increasing by 25 W every 2 minute period. During the test there will be a continuous recording of blood pressure, heart rate and maximum oxygen consumption (VO2max). With this stress test, the aerobic and anaerobic threshold of each participant will be determined to mark the intensity of work at which each subject must perform physical activity in the intervention period.
The interventions of the 2 experimental groups are carried out with a frequency of 3 weekly trainings, for a total period of 16 weeks. The intensity of the training will be assigned to each subject individually based on the stress test performed in the previous phase. Experimental group 1 (HIIT): The HIIT protocol will be carried out after a 10-minute warm-up period with joint mobility exercises and dynamic stretching. The intervention will consist of training in which intense work intervals and active rest periods are combined using a cycle ergometer. The session will be divided into 4 intervals of 4 minutes duration at an intensity of 85-95% of the maximum heart rate [HRM], individually controlled during all sessions (Polar Team pro®), followed by active rest intervals 3 minute duration at 50-70% FCM. After the training, there will be a 10-minute cool down of gentle pedaling and joint range exercises. Experimental group 2 (MICT): Heating phase identical to the previous one. Subsequently, the participants will perform a training on the cycle ergometer with an intensity close to 70% FCM maintained for 40 minutes and will be controlled individually (Polar Team pro®). The session will conclude with a cool down phase identical to the previous one. Control group (CTRL): The participants will receive general advice on the positive effects of the regular practice of physical activity, and they will be given the guide of recommendations for the promotion of physical activity published by the Junta de Andalucía: http: // www.juntadeandalucia.es/salud/servicios/contenidos/andaluciaessalud/docs/130/Guia_Recomendaciones_AF.pdf
- Conditions
- Sarcopenia
- Being tested
- HIIT, MICT
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITOther
It will be carried out after a 10-minute warm-up period with joint mobility exercises and dynamic stretching. The intervention will consist of a training in which intense work intervals and active rest periods are combined using a cycle ergometer. The session will be divided into 4 intervals of 4 minutes duration at an intensity of 85-95% of the maximum heart rate [MHR], individually controlled during all sessions (Polar Team pro®), followed by active rest intervals of 3 minutes duration at 50-70% FCM. After training, a 10-minute cool-down of gentle pedaling and joint range exercises will be carried out.
MICTOther
Heating phase identical to the previous one. Subsequently, the participants will perform training on the cycle ergometer with an intensity close to 70% FCM maintained for 40 minutes and will be individually controlled (Polar Team pro®). The session will conclude with a cool-down phase identical to the previous one.
| Study group | Role | What they receive |
|---|---|---|
| HIIT Group | Experimental | This group receives a training in which intervals of intense work and periods of active rest are combined using a cycle ergometer with an intensity of 85-95% of the maximum heart rate [MHR], followed by intervals of active rest of 3 minutes duration. at 50-70% MCF. Receives: Other: HIIT |
| MICT Group | Experimental | The participants will perform a training on the cycle ergometer with an intensity close to 70% FCM maintained for 40 minutes and will be controlled individually. Receives: Other: MICT |
| Control Group | No intervention | The participants will receive advice on the general positive effects of the regular practice of physical activity, and will be given the guide of recommendations for the promotion of physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip Strength
Dynamometer will be employed to assess handgrip Strength
Measured: Up to twelve weeks
Relative abundance
Determination of the % of specific bacteria in each of the taxonomic levels (phylum, family, genus and species).
Measured: Up to twelve weeks
Biodiversity
Alpha and beta diversity, have a great effect on our health, since greater microbiota diversity is related with health.
Measured: Up to twelve weeks
ABC-16 (Activities Specific Balance Confidence Scale)
Questionnaire that assesses balance confidence in performing activities of daily living. It is calculated by adding up the 16 responses of the questionnaire, with 0 being the minimum score and 100 being the maximum score. The higher value represents a better result.
Measured: Up to twelve weeks
FES-I (Falls Efficacy Scale-International)
Questionnaire that evaluates the fear of falling. The score ranges from 7 to 28 points. Higher values indicate more concern related to falls.
Measured: Up to twelve weeks
PSQI (Pittsburgh Sleep Quality Index)
A simple and valid evaluation of both the quality of sleep and the alterations that may affect it.
It consists of a total of 19 questions, grouped into 10 questions. The 19 questions are combined to form seven domains (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use, and daytime dysfunction, adding up to a total score) with their corresponding score, each one of which shows a range between 0 and 3 points. The higher value represents a worse result. The higher value represents a worse result. Higher bases indicate poorer sleep.
Measured: Up to twelve weeks
HADS (The Hospital Anxiety And Depression)
A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non-patients. The test contains 14 items with a score from 0 to 3, of which 7 items refer to depression and 7 to anxiety. The total score is 0-21, where a higher score corresponds to worse symptoms of anxiety and depression.
Measured: Up to twelve weeks
Percent of Body Fat (%)
Indicates the percentage of body fat to body weight.
Measured: Up to twelve weeks
Secondary outcomes (7)
BMI (Body Mass Index)
Is calculated from the formula, Weight (kg) / Height2 (m2), whose unit is kg/m2. It is a rough indicator of total body fat.
Measured: Up to twelve weeks
TUG (Timed Up and Go test)
Is a simple test used to assess a person's mobility and physical function.
Measured: Up to twelve weeks
Short Physical Performance Battery (SPPB)
It is an instrument that evaluates three aspects of mobility: balance, gait speed and strength of the lower limbs or limbs to get up from a chair.
Measured: Up to twelve weeks
Stabilometric Platform
instrument composed of resistive pressure sensors, used to measure the static or postural balance. The test was performed under both eyes-open and eyes-closed conditions.
Measured: Up to twelve weeks
FSS (Fatigue Severity Scale)
A self-report scale describing the severity of fatigue and the impact of fatigue on activities of daily living. The test is made up of 9 items with 7 response possibilities, so that 1 and 7 correspond to the minimum and maximum severity respectively. The total score corresponds to the sum of all the items with a total score range that goes from 9 to 63.
Measured: Up to twelve weeks
SF-36 (The Short Form-36 Health Survey)
Used extensively for assessing health-related quality of life. The test consists of 36 items that detect both positive and negative health states. The total score ranges from 0 to 100, where 0 represents the worst quality of life and 100 the best.
Measured: Up to twelve weeks
Percent of Body Fat (%)
Indicates the percentage of body fat to body weight.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start20 Dec 2021
- Primary completion10 Jan 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220670
- Sponsor's protocol ID
- University_Jaen
- Status last verified
- Apr 2022
- First submitted
- 16 Dec 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lavilla-Lerma ML, Aibar-Almazan A, Martinez-Amat A, Jimenez-Garcia JD, Hita-Contreras F. Moderate-intensity continuous training and high-intensity interval training modulate the composition of the oral microbiota of elderly adults: Randomized controlled trial. Maturitas. 2024 Jul;185:107973. doi: 10.1016/j.maturitas.2024.107973. Epub 2024 Mar 26.
PubMed 38579579
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia, Active Aging and Oral Microbiota in Older Adults. Effects of a High Intensity Exercises Program by Intervals
- ClinicalTrials.gov ID
- NCT05220670
- Acronym / sponsor ID
- University_Jaen
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 2 Feb 2022 (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.
To analyze the effects of a high intensity exercises program by intervals on sarcopenia, active aging and oral microbiota in older adults.
Detailed description
All participants will be advised to lead healthy lifestyle habits according to the recommendations of the "Plan for the Promotion of Physical Activity and Balanced Eating of the Junta de Andalucía" http://www.juntadeandalucia.es/educacion/webporta/ishareservlet/content/86cf9950-abaa-403b-9fc3 9bc5ecae4614. A submaximal stress test will be performed at the beginning and end of the intervention. Before the test, the participants will become familiar with the measuring instrument with a warm-up that allowed them a gain in understanding the gear system. The test will start with a pedaling cadence of 50 revolutions, with an output power of 0 W, increasing by 25 W every 2 minute period. During the test there will be a continuous recording of blood pressure, heart rate and maximum oxygen consumption (VO2max). With this stress test, the aerobic and anaerobic threshold of each participant will be determined to mark the intensity of work at which each subject must perform physical activity in the intervention period.
The interventions of the 2 experimental groups are carried out with a frequency of 3 weekly trainings, for a total period of 16 weeks. The intensity of the training will be assigned to each subject individually based on the stress test performed in the previous phase. Experimental group 1 (HIIT): The HIIT protocol will be carried out after a 10-minute warm-up period with joint mobility exercises and dynamic stretching. The intervention will consist of training in which intense work intervals and active rest periods are combined using a cycle ergometer. The session will be divided into 4 intervals of 4 minutes duration at an intensity of 85-95% of the maximum heart rate [HRM], individually controlled during all sessions (Polar Team pro®), followed by active rest intervals 3 minute duration at 50-70% FCM. After the training, there will be a 10-minute cool down of gentle pedaling and joint range exercises. Experimental group 2 (MICT): Heating phase identical to the previous one. Subsequently, the participants will perform a training on the cycle ergometer with an intensity close to 70% FCM maintained for 40 minutes and will be controlled individually (Polar Team pro®). The session will conclude with a cool down phase identical to the previous one. Control group (CTRL): The participants will receive general advice on the positive effects of the regular practice of physical activity, and they will be given the guide of recommendations for the promotion of physical activity published by the Junta de Andalucía: http: // www.juntadeandalucia.es/salud/servicios/contenidos/andaluciaessalud/docs/130/Guia_Recomendaciones_AF.pdf
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| HIIT Group | Experimental | Other: HIITThis group receives a training in which intervals of intense work and periods of active rest are combined using a cycle ergometer with an intensity of 85-95% of the maximum heart rate [MHR], followed by intervals of active rest of 3 minutes duration. at 50-70% MCF. |
| MICT Group | Experimental | Other: MICTThe participants will perform a training on the cycle ergometer with an intensity close to 70% FCM maintained for 40 minutes and will be controlled individually. |
| Control Group | No intervention | –The participants will receive advice on the general positive effects of the regular practice of physical activity, and will be given the guide of recommendations for the promotion of physical activity. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥ 65 years
- SARC-F ≥4 or handgrip strength <16 kg for women and < 27 kg for men.
- Not being afflicted by any condition preventing physical activity.
- Not being engaged in regular physical activity >20 minutes and >3 days/week.
- Being able to communicate without difficulty.
Key exclusion criteria (7 listed)
- Acute or terminal illness.
- Unstable cardiovascular conditions.
- Conditions or medical treatments affecting the normal production of saliva (i.e. autoimmune disorders such as Sjögren's syndrome or medications like anxiolytics or antidepressants).
- Being or having been medicated with antibiotics up to one month prior to the taking of samples.
- Alcohol abuse or regular drug abuse.
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 |
|---|---|---|
| HIITIt will be carried out after a 10-minute warm-up period with joint mobility exercises and dynamic stretching. The intervention will consist of a training in which intense work intervals and active rest periods are combined using a cycle ergometer. The session will be divided into 4 intervals of 4 minutes duration at an intensity of 85-95% of the maximum heart rate [MHR], individually controlled during all sessions (Polar Team pro®), followed by active rest intervals of 3 minutes duration at 50-70% FCM. After training, a 10-minute cool-down of gentle pedaling and joint range exercises will be carried out. | Other | HIIT Group |
| MICTHeating phase identical to the previous one. Subsequently, the participants will perform training on the cycle ergometer with an intensity close to 70% FCM maintained for 40 minutes and will be individually controlled (Polar Team pro®). The session will conclude with a cool-down phase identical to the previous one. | Other | MICT Group |
Primary outcome
Handgrip Strength
Time frame: Up to twelve weeks
Dynamometer will be employed to assess handgrip Strength
Relative abundance
Time frame: Up to twelve weeks
Determination of the % of specific bacteria in each of the taxonomic levels (phylum, family, genus and species).
Biodiversity
Time frame: Up to twelve weeks
Alpha and beta diversity, have a great effect on our health, since greater microbiota diversity is related with health.
ABC-16 (Activities Specific Balance Confidence Scale)
Time frame: Up to twelve weeks
Questionnaire that assesses balance confidence in performing activities of daily living. It is calculated by adding up the 16 responses of the questionnaire, with 0 being the minimum score and 100 being the maximum score. The higher value represents a better result.
FES-I (Falls Efficacy Scale-International)
Time frame: Up to twelve weeks
Questionnaire that evaluates the fear of falling. The score ranges from 7 to 28 points. Higher values indicate more concern related to falls.
PSQI (Pittsburgh Sleep Quality Index)
Time frame: Up to twelve weeks
A simple and valid evaluation of both the quality of sleep and the alterations that may affect it. It consists of a total of 19 questions, grouped into 10 questions. The 19 questions are combined to form seven domains (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use, and daytime dysfunction, adding up to a total score) with their corresponding score, each one of which shows a range between 0 and 3 points. The higher value represents a worse result. The higher value represents a worse result. Higher bases indicate poorer sleep.
HADS (The Hospital Anxiety And Depression)
Time frame: Up to twelve weeks
A reliable, valid and practical screening tool for identifying and quantifying anxiety and/or depression in non-patients. The test contains 14 items with a score from 0 to 3, of which 7 items refer to depression and 7 to anxiety. The total score is 0-21, where a higher score corresponds to worse symptoms of anxiety and depression.
Percent of Body Fat (%)
Time frame: Up to twelve weeks
Indicates the percentage of body fat to body weight.
7 secondary outcomes
BMI (Body Mass Index)
Time frame: Up to twelve weeks
TUG (Timed Up and Go test)
Time frame: Up to twelve weeks
Short Physical Performance Battery (SPPB)
Time frame: Up to twelve weeks
Stabilometric Platform
Time frame: Up to twelve weeks
FSS (Fatigue Severity Scale)
Time frame: Up to twelve weeks
SF-36 (The Short Form-36 Health Survey)
Time frame: Up to twelve weeks
Percent of Body Fat (%)
Time frame: Up to twelve 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 27 Apr 2022.
- Derived from this study: PubMed 38579579Lavilla-Lerma ML, Aibar-Almazan A, Martinez-Amat A, Jimenez-Garcia JD, Hita-Contreras F. Moderate-intensity continuous training and high-intensity interval training modulate the composition of the oral microbiota of elderly adults: Randomized controlled trial. Maturitas. 2024 Jul;185:107973. doi: 10.1016/j.maturitas.2024.107973. Epub 2024 Mar 26.
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
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 HIIT and MICT in people with Sarcopenia, run by University of Jaén 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 6 inclusion and 7 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 27 Apr 2022. 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. 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?
Handgrip Strength (time frame: Up to twelve weeks). The study lists 8 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 NCT05220670, which also lists 1 linked publication.
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 27 Apr 2022.