MusclesNCT02899650
Rates of Recovery From Strenuous Exercise in Physically Active Older Adults
A study testing exercise in people with Muscles, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of this study to determine if older adults who are healthy and physically active (i.e., Masters athletes) demonstrate slower rates of recovery from unaccustomed strenuous exercise of downhill running than younger peers. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscles
- 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 Aug 2016to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sedentary (exercise < 1 time/week) or well-trained individuals (exercise ≧ 2 times/week)
- Ages 18-39 and 50-80 years
- Individuals who can safely exercise
Who cannot join
- Individuals who reports "Symptoms or Signs Suggestive of Disease" on the Health Research Questionnaire (heart and respiratory problems, dizziness and ankle edema).
- Individuals who report substance abuse within the last 6 months (elicit drugs, alcohol)
- Smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular Aging Research Lab at UT Austin
Austin, Texas, 78712
About this study
The purpose of this study to determine if older adults who are healthy and physically active (i.e., Masters athletes) demonstrate slower rates of recovery from unaccustomed strenuous exercise of downhill running than younger peers.
Read the detailed description
There is a well-conceived notion that the recovery from strenuous exercise gets slower as individuals get older in age. Studies using animal models have demonstrated that stretching of electrically-activated skeletal muscle to mimic eccentric muscle contractions results in a greater decline and slower recovery in muscular force in old mice than in young mice. Similarly, in human studies using sedentary adults, age has been associated with a slower rate of recovery from a series of eccentric contractions. However, the process of aging is often confounded by coexisting diseases and gradual sedentary lifestyles that progress with advancing aging. Could older adults who are apparently healthy and habitually exercising demonstrate slower rates of recovery from strenuous exercise? In a small-scale study, recreationally-active middle-aged adults did not display a slower recovery from unaccustomed eccentric exercise than young adults. Masters athletes are an effective experimental model to address this question as extrinsic factors (e.g., deconditioning, chronic degenerative diseases) that often confound the intrinsic aging process can be minimized in this population. As no study has been conducted in Masters athletes, it is unknown if Masters athletes would experience slower rates of recovery similar to their sedentary peers.
With this information as background, the general aim of the proposed study is to determine if older adults who are healthy and physically active demonstrate slower rates of recovery from unaccustomed strenuous exercise of downhill running than younger peers. In an attempt to properly determine the influence of aging and regular physical activity, 4 groups of apparently healthy adults, including young sedentary, young trained, older sedentary, and older trained adults, will be studied.
A total of 60 apparently healthy men and women will serve as subjects. Half will be young [18-40-year-old (n=30)] and the other half older [50-80-year-old (n=30)]. After the screening and familiarization, investigators will ask participants to visit the laboratory four times (four consecutive days) to perform downhill running and to test physiological measurements (muscular strength, pain scale, range of motion, arterial stiffness and blood pressure and blood creatinine and myoglobin concentrations).
- Conditions
- Muscles
- Being tested
- exercise
- Keywords
- Delayed Onset Muscle Soreness, Eccentric exercise, Masters athlete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
acute downhill running
| Study group | Role | What they receive |
|---|---|---|
| Young Fit | Experimental | Young (18-39 yrs) people who have endurance training habit Receives: Other: exercise |
| Young Unfit | Experimental | Young (18-39 yrs) people who have sedentary lifestyle. Receives: Other: exercise |
| Older Fit | Experimental | Older (50-80 yrs) people who have endurance training habit Receives: Other: exercise |
| Older Unfit | Experimental | Older (50-80 yrs) people who have sedentary lifestyle Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Force Development
Rate of force development are measured by determining peak torque achieved on an isometric leg extension machine.
Measured: After the downhill running protocol, various markers of muscle damage and muscular strength were obtained 24 hours post (the third visit), 48 hours post (the forth visit) and 72 hours post (the fifth visit).
Secondary outcomes (1)
Pain Scale
Pain scale on quadriceps muscle was assessed using a validated visual pain scale. The scale was on a 10-point scale (0 being absence of soreness, 10 being worst imaginable soreness).
Measured: After the downhill running protocol, muscle damage pain scale was measured 24 hours post (the third visit), 48 hours post (the forth visit) and 72 hours post (the fifth visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start1 Aug 2016
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Why it stopped: This was a research project that was conducted by a visiting scholar and his time for departure came earlier than the study completion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MusclesStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hirofumi Tanaka, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899650
- Sponsor's protocol ID
- 2016-04-0070
- Status last verified
- Jan 2021
- First submitted
- 2 Sep 2016
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lavender AP, Nosaka K. Changes in markers of muscle damage of middle-aged and young men following eccentric exercise of the elbow flexors. J Sci Med Sport. 2008 Apr;11(2):124-31. doi: 10.1016/j.jsams.2006.11.004. Epub 2007 Mar 9.
PubMed 17350334Dedrick ME, Clarkson PM. The effects of eccentric exercise on motor performance in young and older women. Eur J Appl Physiol Occup Physiol. 1990;60(3):183-6. doi: 10.1007/BF00839156.
PubMed 2347319Brooks SV, Faulkner JA. Contraction-induced injury: recovery of skeletal muscles in young and old mice. Am J Physiol. 1990 Mar;258(3 Pt 1):C436-42. doi: 10.1152/ajpcell.1990.258.3.C436.
PubMed 2316632Brooks SV, Faulkner JA. The magnitude of the initial injury induced by stretches of maximally activated muscle fibres of mice and rats increases in old age. J Physiol. 1996 Dec 1;497 ( Pt 2)(Pt 2):573-80. doi: 10.1113/jphysiol.1996.sp021790.
PubMed 8961197
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rates of Recovery From Strenuous Exercise in Physically Active Older Adults
- ClinicalTrials.gov ID
- NCT02899650
- Acronym / sponsor ID
- 2016-04-0070
- Conditions
- Muscles
- Keywords
- Delayed Onset Muscle Soreness, Eccentric exercise, Masters athlete
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This was a research project that was conducted by a visiting scholar and his time for departure came earlier than the study completion.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study to determine if older adults who are healthy and physically active (i.e., Masters athletes) demonstrate slower rates of recovery from unaccustomed strenuous exercise of downhill running than younger peers.
Detailed description
There is a well-conceived notion that the recovery from strenuous exercise gets slower as individuals get older in age. Studies using animal models have demonstrated that stretching of electrically-activated skeletal muscle to mimic eccentric muscle contractions results in a greater decline and slower recovery in muscular force in old mice than in young mice. Similarly, in human studies using sedentary adults, age has been associated with a slower rate of recovery from a series of eccentric contractions. However, the process of aging is often confounded by coexisting diseases and gradual sedentary lifestyles that progress with advancing aging. Could older adults who are apparently healthy and habitually exercising demonstrate slower rates of recovery from strenuous exercise? In a small-scale study, recreationally-active middle-aged adults did not display a slower recovery from unaccustomed eccentric exercise than young adults. Masters athletes are an effective experimental model to address this question as extrinsic factors (e.g., deconditioning, chronic degenerative diseases) that often confound the intrinsic aging process can be minimized in this population. As no study has been conducted in Masters athletes, it is unknown if Masters athletes would experience slower rates of recovery similar to their sedentary peers.
With this information as background, the general aim of the proposed study is to determine if older adults who are healthy and physically active demonstrate slower rates of recovery from unaccustomed strenuous exercise of downhill running than younger peers. In an attempt to properly determine the influence of aging and regular physical activity, 4 groups of apparently healthy adults, including young sedentary, young trained, older sedentary, and older trained adults, will be studied.
A total of 60 apparently healthy men and women will serve as subjects. Half will be young [18-40-year-old (n=30)] and the other half older [50-80-year-old (n=30)]. After the screening and familiarization, investigators will ask participants to visit the laboratory four times (four consecutive days) to perform downhill running and to test physiological measurements (muscular strength, pain scale, range of motion, arterial stiffness and blood pressure and blood creatinine and myoglobin concentrations).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young Fit | Experimental | Other: exerciseYoung (18-39 yrs) people who have endurance training habit |
| Young Unfit | Experimental | Other: exerciseYoung (18-39 yrs) people who have sedentary lifestyle. |
| Older Fit | Experimental | Other: exerciseOlder (50-80 yrs) people who have endurance training habit |
| Older Unfit | Experimental | Other: exerciseOlder (50-80 yrs) people who have sedentary lifestyle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sedentary (exercise < 1 time/week) or well-trained individuals (exercise ≧ 2 times/week)
- Ages 18-39 and 50-80 years
- Individuals who can safely exercise
Key exclusion criteria (3 listed)
- Individuals who reports "Symptoms or Signs Suggestive of Disease" on the Health Research Questionnaire (heart and respiratory problems, dizziness and ankle edema).
- Individuals who report substance abuse within the last 6 months (elicit drugs, alcohol)
- Smokers
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 |
|---|---|---|
| exerciseacute downhill running | Other | Older Fit, Older Unfit, Young Fit, Young Unfit |
Primary outcome
Rate of Force Development
Time frame: After the downhill running protocol, various markers of muscle damage and muscular strength were obtained 24 hours post (the third visit), 48 hours post (the forth visit) and 72 hours post (the fifth visit).
Rate of force development are measured by determining peak torque achieved on an isometric leg extension machine.
1 secondary outcome
Pain Scale
Time frame: After the downhill running protocol, muscle damage pain scale was measured 24 hours post (the third visit), 48 hours post (the forth visit) and 72 hours post (the fifth visit).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17350334Lavender AP, Nosaka K. Changes in markers of muscle damage of middle-aged and young men following eccentric exercise of the elbow flexors. J Sci Med Sport. 2008 Apr;11(2):124-31. doi: 10.1016/j.jsams.2006.11.004. Epub 2007 Mar 9.
- Background: PubMed 2347319Dedrick ME, Clarkson PM. The effects of eccentric exercise on motor performance in young and older women. Eur J Appl Physiol Occup Physiol. 1990;60(3):183-6. doi: 10.1007/BF00839156.
- Background: PubMed 2316632Brooks SV, Faulkner JA. Contraction-induced injury: recovery of skeletal muscles in young and old mice. Am J Physiol. 1990 Mar;258(3 Pt 1):C436-42. doi: 10.1152/ajpcell.1990.258.3.C436.
- Background: PubMed 8961197Brooks SV, Faulkner JA. The magnitude of the initial injury induced by stretches of maximally activated muscle fibres of mice and rats increases in old age. J Physiol. 1996 Dec 1;497 ( Pt 2)(Pt 2):573-80. doi: 10.1113/jphysiol.1996.sp021790.
- PubmedLink provided by the sponsor.
- 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 exercise in people with Muscles, 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 3 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: stopped early, as of the sponsor's last update on 22 Jan 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 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?
Yes. Results are posted in the registry (first posted 22 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Force Development (time frame: After the downhill running protocol, various markers of muscle damage and muscular strength were obtained 24 hours post (the third visit), 48 hours post (the forth visit) and 72 hours post (the fifth visit).). 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 NCT02899650, which also lists 4 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 22 Jan 2021.