Exercise Training and SarcopeniaNCT04641117
Time Efficient Exercise to Reverse Sarcopenia and Improve Cardio-metabolic Health
A study testing Exercise in people with Exercise Training and Sarcopenia, run by University of Texas at Austin at 1 site in United States.
Trial summary
Participants will be 60-80 y men and women who vary their physical activity (steps/day) while their lipid metabolism is studied (n=24). Thereafter, another group (n=60) will perform 6 months of exercise training focused on developing maximal cycling power, during which their changes in muscle mass and practical… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training and Sarcopenia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- relatively healthy
Who cannot join
- relatively unhealthy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas at Austin Human Performance Laboratory
Austin, Texas, 78712
About this study
Participants will be 60-80 y men and women who vary their physical activity (steps/day) while their lipid metabolism is studied (n=24). Thereafter, another group (n=60) will perform 6 months of exercise training focused on developing maximal cycling power, during which their changes in muscle mass and practical function will be carefully measured.
Read the detailed description
In a society that is growing in the number of older adults who are also becoming more sedentary, it is critical to identify the types of exercise that harness significant health benefits. First, we hypothesize that older adults (60-80 y) need a certain background level of physical activity, judged by number of steps per day. This is important, especially to fat metabolism. Secondly, because older adults claim they don't have time to exercise, we have developed a time efficient program (10 min/day) that has shown promise for offsetting sarcopenia and significantly improving cardiovascular function.
Our Aim 1 is to determine the range of daily step counts in older adults (60-80 y; n=24) that is needed to prevent acute impairment of post-prandial fat metabolism, measured the morning after exercise. We have recently shown in young adults that when their level of background physical activity drops below the range of 5,000 - 8,500±500 steps/d, that they don't adapt positively to an acute 1 h bout of exercise (i.e.; 'exercise resistance') that normally improves fat metabolism.
Our Aim 2 is to determine the ability of a time-efficient 24-week program of exercise training for both maximal neuromuscular power and aerobic power to counteract sarcopenia and declines in aerobic power and functional tests in men and women 60-80 y. We have recently found in a preliminary study of older men and women (50-70 y) that performing multiple maximal 4 s sprints of rapid acceleration cycling bouts for only 8 weeks, eliciting maximal power, displayed significant (p<0.05) increases in muscle thigh volume (MRI), whole body muscle mass, maximal neuromuscular power and peak oxygen consumption. We now propose to train older men and women (i.e.; 60-80 y; n=60) for longer durations (i.e.; 24 weeks) and describe the time course of adaptations. We will additionally monitor their background levels of daily physical activity and determine if it correlates with improvements in neuromuscular and cardiovascular function.
- Conditions
- Exercise Training and Sarcopenia
- Being tested
- Exercise
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Walking and Power Training
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Six months of power training Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
MRI determined changes in thigh muscle volume
Measured: six months
Post-prandial lipemia
The elevation of plasma triglycerides after a meal
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Training and SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will power train
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641117
- Sponsor's protocol ID
- UTexasAustinKHE
- Status last verified
- Nov 2020
- First submitted
- 17 Nov 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Efficient Exercise to Reverse Sarcopenia and Improve Cardio-metabolic Health
- ClinicalTrials.gov ID
- NCT04641117
- Acronym / sponsor ID
- UTexasAustinKHE
- Conditions
- Exercise Training and Sarcopenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Nov 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.
Participants will be 60-80 y men and women who vary their physical activity (steps/day) while their lipid metabolism is studied (n=24). Thereafter, another group (n=60) will perform 6 months of exercise training focused on developing maximal cycling power, during which their changes in muscle mass and practical function will be carefully measured.
Detailed description
In a society that is growing in the number of older adults who are also becoming more sedentary, it is critical to identify the types of exercise that harness significant health benefits. First, we hypothesize that older adults (60-80 y) need a certain background level of physical activity, judged by number of steps per day. This is important, especially to fat metabolism. Secondly, because older adults claim they don't have time to exercise, we have developed a time efficient program (10 min/day) that has shown promise for offsetting sarcopenia and significantly improving cardiovascular function.
Our Aim 1 is to determine the range of daily step counts in older adults (60-80 y; n=24) that is needed to prevent acute impairment of post-prandial fat metabolism, measured the morning after exercise. We have recently shown in young adults that when their level of background physical activity drops below the range of 5,000 - 8,500±500 steps/d, that they don't adapt positively to an acute 1 h bout of exercise (i.e.; 'exercise resistance') that normally improves fat metabolism.
Our Aim 2 is to determine the ability of a time-efficient 24-week program of exercise training for both maximal neuromuscular power and aerobic power to counteract sarcopenia and declines in aerobic power and functional tests in men and women 60-80 y. We have recently found in a preliminary study of older men and women (50-70 y) that performing multiple maximal 4 s sprints of rapid acceleration cycling bouts for only 8 weeks, eliciting maximal power, displayed significant (p<0.05) increases in muscle thigh volume (MRI), whole body muscle mass, maximal neuromuscular power and peak oxygen consumption. We now propose to train older men and women (i.e.; 60-80 y; n=60) for longer durations (i.e.; 24 weeks) and describe the time course of adaptations. We will additionally monitor their background levels of daily physical activity and determine if it correlates with improvements in neuromuscular and cardiovascular function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will power train
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseSix months of power training |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- relatively healthy
Key exclusion criteria (1 listed)
- relatively unhealthy
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 |
|---|---|---|
| ExerciseWalking and Power Training | Other | Exercise |
Primary outcome
Muscle mass
Time frame: six months
MRI determined changes in thigh muscle volume
Post-prandial lipemia
Time frame: one month
The elevation of plasma triglycerides after a meal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 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.
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 Exercise in people with Exercise Training and Sarcopenia, run by University of Texas at Austin at 1 site in United States.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Nov 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Muscle mass (time frame: six months). The study lists 2 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 23 Nov 2020.