SarcopeniaTrain-OldNCT05481346
Effects of Multidomain Training of Health With Aging (Train-Old)
A study testing Multidomain training in people with Sarcopenia and Memory Loss, run by Universidad de Almeria at 1 site in Spain.
Trial summary
The current study aims to determine the effect of a multidomain intervention (physical fitness, motivational and cognitive training) on body composition, sarcopenia, cardiovascular health, physical fitness, functional capacity, quality of life, frailty, emotional state and cognitive status in elderly participants… Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Memory Loss, Muscular Atrophy
- What is being tested?
- Multidomain training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jul 2022to 30 Dec 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 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has provided written and dated informed consent to participate in the study.
- Subject is a male or female between 55 and 90 years of age, inclusive.
- Subject is in good health as determined by a health history questionnaire and has been provided clearance from their personal physician.
- Subject is untrained in resistance and aerobic exercise (does not participate in structured physical activity, including walking, more than 3 times per week).
- Ability to walk independently without any gait aid
Who cannot join
- Perform high-intensity aerobic exercise on a consistent basis (>180 min-week).
- Be performing some other regular and systematic strength training program during the intervention in the first half of 2022.
- Have a body mass index greater than 35.
- Have a diagnosis of ischemic heart disease.
- Have a diagnosis of severe aortic stenosis, uncontrolled arrhythmias, decompensated heart failure or acute myocarditis.
- Possess uncontrolled blood pressure (TAS >180 and TAD >110).
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- Stroke.
- Severe peripheral arterial disease.
- Other illnesses such as recent thromboembolic disease, aortic aneurysm, clinically significant renal or hepatic insufficiency, severe COPD, clinically significant acute infections, severe psychiatric illness, uncontrolled metabolic disease, limiting locomotor pathology or musculoskeletal disease worsened by exercise, hormone therapy at the time or one year prior, being a woman with surgical menopause.
- Other pathologies that contraindicate the practice of physical exercise, collected in the previous medical examination that all participants must undergo.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Pablo Jorge Marcos Pardo
Almería
Pablo Jorge Marcos Pardo, PhD, pjmarcos@ual.es
Antonio Jesús Casimiro Andújar, PhD, casimiro@ual.es
About this study
Official title: Psycho-physiological Effects of Multidomain Training in Adults and Older Adults
The current study aims to determine the effect of a multidomain intervention (physical fitness, motivational and cognitive training) on body composition, sarcopenia, cardiovascular health, physical fitness, functional capacity, quality of life, frailty, emotional state and cognitive status in elderly participants, through a randomized controlled trial, to determine its suitability and recommend it as a preventive and health strategy for community-dwelling older adults.
- Conditions
- Sarcopenia, Memory Loss, Muscular Atrophy, Cardiovascular Diseases, Frailty
- Being tested
- Multidomain training
- Keywords
- older adults, Healthy aging, Resistance training, cognitive training, cardiovascular training
- Medical subject headings
- Sarcopenia, Memory Disorders, Muscular Atrophy, Cardiovascular Diseases, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain trainingProcedure or surgery
The training program has a duration of 18 weeks with 2 training sessions per week. The training will have a gradual progression of intensity. One day they train two blocks of strength and one block of cognitive exercises and on the second day, they train one block of power, one block of strength+cognitive and one block of aerobic training.
All sessions are 60 minutes long (10 minutes of warm-up, 40 minutes of training and 10 minutes of cool-down). Classes are in small groups of no more than 8 members.
| Study group | Role | What they receive |
|---|---|---|
| Multidomain training group | Experimental | Participants will use free weights and functional materials to work the main muscle groups. In addition, they will perform cardiorespiratory training and cognitive training with proposed tasks. Participants will follow the planned training progression. The researchers will record the number of sets completed and the load lifted for each exercise for each participant and the perception of effort in each class. Receives: Procedure: Multidomain training |
| Control group | No intervention | The control group did not receive a training program and were asked not to modify their physical activity habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight in Kilograms
was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.
Measured: Change from Baseline body weight (kg) at 18 weeks
Height in Meters
Standing height without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm.
Measured: Change from Baseline standing height (cm) at 18 weeks
Body Mass Index (BMI)
was calculated as the ratio of weight to squared height in kg/m^2
Measured: Change from Baseline Body Mass Index (BMI): (kg/m^2) at 18 weeks
% Fat Mass
% fat mass was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.
Measured: Change from Baseline bioelectrical impedance % fat mass at 18 weeks
Muscle quality sarcopenia
Sarcopenia will be assessed taking into account the reference values established for muscle quality. The muscle quality will be measure by hand grip strength test. This test will be performance with manual dynamometry (TKK 5401; Scientific Instruments Co., Ltd., Tokyo, Japan). Maximal isometric upper limb strength will be performance by maximal isometric strength. Upper strength will be register by kilogrammes. Higher value show high strength.
Measured: Change from Baseline to 18 weeks
Secondary outcomes (16)
Change Blood pressure
Blood pressure and heart rate will be assessed by means of an automatic device (Colin BP 880, Inc., Tampa, FL). This is noninvasive technique. The result will be register in millimeters of mercury (bood pressure) and number of pulse per minutes (heart rate).
Measured: Change from Baseline to 18 weeks
Change Chair stand test
Chair stand test measure the functional capacity. This is a easy physical test. This test measures the functionality of getting up and sitting down from a chair five times. The participant have to performance the test as faster as possible. The total time is recorded in seconds. A better time indicates better functional ability.
Measured: Change from Baseline to 18 weeks
Change Upper and Lower strength
Maximal isometric upper limb strength will be performance by maximal isometric strength of knee extension and biceps flexion with load cell. Maximal isometric lower limb will be registered in newton. Higher value show high strength.
Measured: Change from Baseline to 18 weeks
Health-related quality
SF-36 quality of life questionnaire
Measured: Change from Baseline to 18 weeks
Cardiorrespiratory 6 minutes walk test
cardiorespiratory endurance test that evaluates the distance covered in 6 minutes.
Measured: Change from Baseline to 18 weeks
Change heart rate
Heart rate will be assessed by means of an automatic device (Colin BP 880, Inc., Tampa, FL). This is noninvasive technique. The result will be register in number of pulse per minutes (heart rate).
Measured: Change from Baseline to 18 weeks
Gait speed
Gait speed will be measure by 4. 6 and 10 meter test. This is easy physical test in with the participant have to walk 4. 6 and 10 metres as faster as possible. The result will be register in seconds. Less time indicates better functional ability.
Measured: Change from Baseline to 18 weeks
Time up and go test change
Time up and go test measure the functional capacity of getting up, walking and sitting down form a chair. Participant have to performance this test as faster as possible. This is a easy physical test. Total seconds are records. Less seconds indicates better functional ability.
Measured: Change from Baseline to 18 weeks
Short physical performance battery (SPPB)
Short physical performance battery (SPBB) include three test (balance, chair stand test and gait speed) and report a final score. Chair stand test and gait speed were describe in other outcome. Balance test is a easy physical test. The participant must maintain three balancing positions for 10 seconds to overcome it. Each test offers a different score. Higher score show better functional capacity.
Measured: Change from Baseline to 18 weeks
Fragility
Frailty will be defined in relation to Fried's frailty phenotype (Fried et al., 2001), based on 5 criteria: unintentional weight loss, exhaustion, weakness, slow walking speed and low physical activity.
Measured: Change from Baseline to 18 weeks
Satisfaction with life
The Satisfaction with Life Scale is a 4-item instrument with a Likert-type scale ranging from 1 to 7 points measuring overall subjective happiness by means of statements in which participants rate themselves or compare themselves with others. Two items ask people to describe themselves using absolute rating criteria of their lives or rating criteria with respect to others, while the other two items present brief descriptions of happy or unhappy people and respondents are asked to indicate the degree to which they identify with that description.
Measured: Change from Baseline to 18 weeks
Depression
Depression will be measured through the Center for Epidemiological Studies Depression Scale-Revised (CESD-R) (Van Dam \& Earleywine, 2011), is a 20-item questionnaire that can be used to measure levels of depressive symptoms among elderly participants. The CESD-R consists of 16 items of negative affect and 4 items of positive affect.
Measured: Change from Baseline to 18 weeks
Cognitive flexibility
the Stroop test measures the ability to classify information selectively. It consists of 3 phases and requires discerning between colors and words without making mistakes.
Measured: Change from Baseline to 18 weeks
Attention test
the Trail Making test will also assess flexibility of thought and visuospatial ability. It consists of joining numbers and words in a numerical sequence without error.
Measured: Change from Baseline to 18 weeks
PSQ test
To evaluate the factors that influence the general state of health, specifically stress. It evaluates six factors: Tension-Instability-Fatigue; Social Acceptance of Conflict; Energy and Fun; Overload; Satisfaction for self-fulfillment; Fear and anxiety.
Measured: Change from Baseline to 18 weeks
TMMS-24
Trait-Meta Mood Scale (TMMS) emotional states
Measured: Change from Baseline to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start28 Jul 2022
- Primary completion18 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Participants will be randomly assigned to an experimental group that will perform the physical exercise program and a control group that will perform nothing and continue with their normal lifestyle routines, without any physical activity.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Jorge Marcos Pardo, Universidad de Almeria
- Investigators
- Pablo Jorge Marcos Pardo, PhD, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481346
- Sponsor's protocol ID
- UALBIO2022/011
- Acronym
- Train-Old
- Status last verified
- Jul 2022
- First submitted
- 28 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the data are published, the data can be requested and will be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psycho-physiological Effects of Multidomain Training in Adults and Older Adults
- ClinicalTrials.gov ID
- NCT05481346
- Acronym / sponsor ID
- Train-Old / UALBIO2022/011
- Conditions
- Sarcopenia, Memory Loss, Muscular Atrophy, Cardiovascular Diseases, Frailty
- Keywords
- older adults, Healthy aging, Resistance training, cognitive training, cardiovascular training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 18 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 1 Aug 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.
The current study aims to determine the effect of a multidomain intervention (physical fitness, motivational and cognitive training) on body composition, sarcopenia, cardiovascular health, physical fitness, functional capacity, quality of life, frailty, emotional state and cognitive status in elderly participants, through a randomized controlled trial, to determine its suitability and recommend it as a preventive and health strategy for community-dwelling older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to an experimental group that will perform the physical exercise program and a control group that will perform nothing and continue with their normal lifestyle routines, without any physical activity.
| Arm | Type | Receives |
|---|---|---|
| Multidomain training group | Experimental | Procedure: Multidomain trainingParticipants will use free weights and functional materials to work the main muscle groups. In addition, they will perform cardiorespiratory training and cognitive training with proposed tasks. Participants will follow the planned training progression. The researchers will record the number of sets completed and the load lifted for each exercise for each participant and the perception of effort in each class. |
| Control group | No intervention | –The control group did not receive a training program and were asked not to modify their physical activity habits. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has provided written and dated informed consent to participate in the study.
- Subject is a male or female between 55 and 90 years of age, inclusive.
- Subject is in good health as determined by a health history questionnaire and has been provided clearance from their personal physician.
- Subject is untrained in resistance and aerobic exercise (does not participate in structured physical activity, including walking, more than 3 times per week).
- Ability to walk independently without any gait aid
Key exclusion criteria (10 listed)
- Perform high-intensity aerobic exercise on a consistent basis (>180 min-week).
- Be performing some other regular and systematic strength training program during the intervention in the first half of 2022.
- Have a body mass index greater than 35.
- Have a diagnosis of ischemic heart disease.
- Have a diagnosis of severe aortic stenosis, uncontrolled arrhythmias, decompensated heart failure or acute myocarditis.
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 |
|---|---|---|
| Multidomain trainingThe training program has a duration of 18 weeks with 2 training sessions per week. The training will have a gradual progression of intensity. One day they train two blocks of strength and one block of cognitive exercises and on the second day, they train one block of power, one block of strength+cognitive and one block of aerobic training. All sessions are 60 minutes long (10 minutes of warm-up, 40 minutes of training and 10 minutes of cool-down). Classes are in small groups of no more than 8 members. | Procedure or surgery | Multidomain training group |
Primary outcome
Body Weight in Kilograms
Time frame: Change from Baseline body weight (kg) at 18 weeks
was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.
Height in Meters
Time frame: Change from Baseline standing height (cm) at 18 weeks
Standing height without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm.
Body Mass Index (BMI)
Time frame: Change from Baseline Body Mass Index (BMI): (kg/m^2) at 18 weeks
was calculated as the ratio of weight to squared height in kg/m^2
% Fat Mass
Time frame: Change from Baseline bioelectrical impedance % fat mass at 18 weeks
% fat mass was measured after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA or InBody equipment to the nearest 0.1 kg.
Muscle quality sarcopenia
Time frame: Change from Baseline to 18 weeks
Sarcopenia will be assessed taking into account the reference values established for muscle quality. The muscle quality will be measure by hand grip strength test. This test will be performance with manual dynamometry (TKK 5401; Scientific Instruments Co., Ltd., Tokyo, Japan). Maximal isometric upper limb strength will be performance by maximal isometric strength. Upper strength will be register by kilogrammes. Higher value show high strength.
16 secondary outcomes
Change Blood pressure
Time frame: Change from Baseline to 18 weeks
Change Chair stand test
Time frame: Change from Baseline to 18 weeks
Change Upper and Lower strength
Time frame: Change from Baseline to 18 weeks
Health-related quality
Time frame: Change from Baseline to 18 weeks
Cardiorrespiratory 6 minutes walk test
Time frame: Change from Baseline to 18 weeks
Change heart rate
Time frame: Change from Baseline to 18 weeks
Gait speed
Time frame: Change from Baseline to 18 weeks
Time up and go test change
Time frame: Change from Baseline to 18 weeks
Short physical performance battery (SPPB)
Time frame: Change from Baseline to 18 weeks
Fragility
Time frame: Change from Baseline to 18 weeks
Satisfaction with life
Time frame: Change from Baseline to 18 weeks
Depression
Time frame: Change from Baseline to 18 weeks
Cognitive flexibility
Time frame: Change from Baseline to 18 weeks
Attention test
Time frame: Change from Baseline to 18 weeks
PSQ test
Time frame: Change from Baseline to 18 weeks
TMMS-24
Time frame: Change from Baseline to 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No. Once the data are published, the data can be requested and will be made available to other researchers.
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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.
Pablo Jorge Marcos Pardo, PhD principal investigator
Universidad de Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain training in people with Sarcopenia and Memory Loss, run by Universidad de Almeria 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 10 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: status not confirmed, as of the sponsor's last update on 2 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo Jorge Marcos Pardo, PhD (+34 950214791, pjmarcos@ual.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight in Kilograms (time frame: Change from Baseline body weight (kg) at 18 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2022.