Muscle WeaknessNCT04315662
Power Training on Muscle Quality and Functional Capacity in Women Aged 65-75.
A study testing Muscle power training with velocity loss (VL) of 10% and Muscle power training with velocity loss (VL) of 30% in people with Muscle Weakness and Muscle Loss, run by Universidad del Valle, Colombia at 1 site in Colombia.
Trial summary
Muscle power training has proven to be an effective intervention to prevent sarcopenia and frailty in old people. In the last decade, new concepts related to the functionality of old people have been generated, such as muscle quality and functional capacity. Read more about this study
- Who is it for?
- Ages 65 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness, Muscle Loss
- What is being tested?
- Muscle power training with velocity loss (VL) of 10% and Muscle power training with velocity loss (VL) of 30%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteColombia
- Study dates
- 1 May 2020to 11 Feb 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 75 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Women 65 to 75 years.
- Healthy volunteers.
- Have not perform muscle power training in the last six months.
Who cannot join
- History of asthma.
- History of uncontrolled diabetes.
- History of uncontrolled hypertension.
- History of cardiovascular disease.
- History of coronary heart disease.
- Smoker.
Show all 11Show fewer
- Arrhythmias.
- Personal history of surgical procedures in the last three months.
- Uncontrolled non-communicable diseases.
- Psychological, sensitive, cognitive, neuromotor and/or osteo-muscular conditions that may affect participation in an exercise program.
- Under medical treatment with anticoagulants, bronchodilators, and/or steroids.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Universidad del Valle
Cali, Valle del Cauca Department
Santiago A Arboleda, Ph.D., +573164459690, santiago.arboleda@correounivalle.edu.co
Fredy A Patiño, Ph.D.
About this study
Official title: Effects of a Power Training at Two Different Loads on Muscle Quality and Functional Capacity in Women Aged 65-75.
Muscle power training has proven to be an effective intervention to prevent sarcopenia and frailty in old people. In the last decade, new concepts related to the functionality of old people have been generated, such as muscle quality and functional capacity.
The power training consists of rapid movements of short duration that imply a more specialized neuromuscular response and that improve the functional response reflected in activities of daily life that demand a certain manifestation of muscular power (stand up of a chair, climbing stairs, rebalance, accelerate suddenly, among others). Therefore, it is important to investigate the dose-response relationships in power training in older people and establish how possible improvements in muscle quality can be reflected in functional capacity.
The aim of this study is to compare the effects of power training at two different loads on muscle quality and functional capacity in women aged 65-75
Read the detailed description
Fifty-six women will be randomly assigned to one of two muscle power training supervised for a physical activity instructor with different velocity loss (VL) thresholds: 10% (VL10) and 30% (VL30). Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min.
Before and after the muscle power training the following tests will be performed: 1) measure of body composition with dual-energy x-ray absorptiometry for determining the lean mass of thighs; 2) three functional test (chair stand test, time up go test with cognitive task and gait speed test); 3)Progressive loading test in a leg extension machine until finding the mean muscle power corresponding to 50% of 1RM (speed of concentric phase of 6.67 ± 0.04 m/s measured using a camera-based optoelectronic system).
- Conditions
- Muscle Weakness, Muscle Loss
- Being tested
- Muscle power training with velocity loss (VL) of 10%, Muscle power training with velocity loss (VL) of 30%
- Keywords
- Muscle quality, Functional capacity, Power training
- Medical subject headings
- Muscle Weakness, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle power training with velocity loss (VL) of 10%Other
Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min. Velocity loss will be of 10% (VL10) in each set.
Muscle power training with velocity loss (VL) of 30%Other
Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min. Velocity loss will be of 30% (VL30) in each set.
| Study group | Role | What they receive |
|---|---|---|
| Muscle power training with velocity loss (VL) of 10% | Experimental | Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min. Velocity loss will be of 10% (VL10) in each set. Receives: Other: Muscle power training with velocity loss (VL) of 10% |
| Muscle power training with velocity loss (VL) of 30% | Active comparator | Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min. Velocity loss will be of 30% (VL30) in each set. Receives: Other: Muscle power training with velocity loss (VL) of 30% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on muscle quality: obtained by measuring mean leg extension power divided by muscle mass of thighs
The muscle quality will be obtained by measuring mean leg extension power divided by muscle mass of thighs (measured by dual-energy x-ray absorptiometry)
Measured: Baseline and after 8 weeks
Secondary outcomes (3)
Change on chair stand test
Participants stand up straight as quickly as they can five times, without stopping in between. After standing up each time, subjects will sit down and then stand up again. They will keep their arms folded across their chest. The examiner will be timing with a stopwatch.
Measured: Baseline and after 8 weeks
Change on time up go test with cognitive task
The participant stands up from a chair, walks to the mark 3 m away, turns around, returns to the chair, and sits down again. The participants walk safely, as fast as possible. While walking, the participant counts backward in threes from a randomly chosen start number between 60 and 100 to avoid a learning effect.
Measured: Baseline and after 8 weeks
Change on gait speed test
Participants walk a 4-m marked course at their usual walking pace, with the examiner timing their walk with a stopwatch.
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 May 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion11 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad del Valle, Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Antioquia
- Responsible party
- Sponsor
- Investigators
- Santiago A Arboleda, Ph.D., Principal investigator, Universidad del Valle, Cali, Colombia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04315662
- Sponsor's protocol ID
- CI5302
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Power Training at Two Different Loads on Muscle Quality and Functional Capacity in Women Aged 65-75.
- ClinicalTrials.gov ID
- NCT04315662
- Acronym / sponsor ID
- CI5302
- Conditions
- Muscle Weakness, Muscle Loss
- Keywords
- Muscle quality, Functional capacity, Power training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Universidad del Valle, ColombiaUniversity, hospital or other
- Collaborators
- Universidad de Antioquia
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 11 Feb 2021 (estimated)
- First posted
- 19 Mar 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.
Muscle power training has proven to be an effective intervention to prevent sarcopenia and frailty in old people. In the last decade, new concepts related to the functionality of old people have been generated, such as muscle quality and functional capacity.
The power training consists of rapid movements of short duration that imply a more specialized neuromuscular response and that improve the functional response reflected in activities of daily life that demand a certain manifestation of muscular power (stand up of a chair, climbing stairs, rebalance, accelerate suddenly, among others). Therefore, it is important to investigate the dose-response relationships in power training in older people and establish how possible improvements in muscle quality can be reflected in functional capacity.
The aim of this study is to compare the effects of power training at two different loads on muscle quality and functional capacity in women aged 65-75
Detailed description
Fifty-six women will be randomly assigned to one of two muscle power training supervised for a physical activity instructor with different velocity loss (VL) thresholds: 10% (VL10) and 30% (VL30). Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min.
Before and after the muscle power training the following tests will be performed: 1) measure of body composition with dual-energy x-ray absorptiometry for determining the lean mass of thighs; 2) three functional test (chair stand test, time up go test with cognitive task and gait speed test); 3)Progressive loading test in a leg extension machine until finding the mean muscle power corresponding to 50% of 1RM (speed of concentric phase of 6.67 ± 0.04 m/s measured using a camera-based optoelectronic system).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle power training with velocity loss (VL) of 10% | Experimental | Other: Muscle power training with velocity loss (VL) of 10%Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min. Velocity loss will be of 10% (VL10) in each set. |
| Muscle power training with velocity loss (VL) of 30% | Active comparator | Other: Muscle power training with velocity loss (VL) of 30%Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min. Velocity loss will be of 30% (VL30) in each set. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Women 65 to 75 years.
- Healthy volunteers.
- Have not perform muscle power training in the last six months.
Key exclusion criteria (11 listed)
- History of asthma.
- History of uncontrolled diabetes.
- History of uncontrolled hypertension.
- History of cardiovascular disease.
- History of coronary heart disease.
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 |
|---|---|---|
| Muscle power training with velocity loss (VL) of 10%Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min. Velocity loss will be of 10% (VL10) in each set. | Other | Muscle power training with velocity loss (VL) of 10% |
| Muscle power training with velocity loss (VL) of 30%Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min. Velocity loss will be of 30% (VL30) in each set. | Other | Muscle power training with velocity loss (VL) of 30% |
Primary outcome
Change on muscle quality: obtained by measuring mean leg extension power divided by muscle mass of thighs
Time frame: Baseline and after 8 weeks
The muscle quality will be obtained by measuring mean leg extension power divided by muscle mass of thighs (measured by dual-energy x-ray absorptiometry)
3 secondary outcomes
Change on chair stand test
Time frame: Baseline and after 8 weeks
Change on time up go test with cognitive task
Time frame: Baseline and after 8 weeks
Change on gait speed test
Time frame: Baseline and after 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- 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.
Santiago A Arboleda, Ph.D. principal investigator
Universidad del Valle, Cali, Colombia.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle power training with velocity loss (VL) of 10% and Muscle power training with velocity loss (VL) of 30% in people with Muscle Weakness and Muscle Loss, run by Universidad del Valle, Colombia at 1 site in Colombia.
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 3 inclusion and 11 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 19 Mar 2020. 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 Colombia. 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 Santiago A Arboleda, Ph.D. (+573164459690, santiago.arboleda@correounivalle.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on muscle quality: obtained by measuring mean leg extension power divided by muscle mass of thighs (time frame: Baseline and after 8 weeks). 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 19 Mar 2020.