Biological AgingNCT03440099
Sex-specific Adaptation to Resistance Training in Older Adults
A study testing Resistance exercise training in people with Biological Aging, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
In general, men and women experience differing degrees of age-related decreases in physical function, with women having a greater prevalence of functional limitations and disability. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Biological Aging
- What is being tested?
- Resistance exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 31 Mar 2024
- 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
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older adult (65-75 years old) volunteers will be healthy, by self-report, and sedentary, defined as no formal exercise program for the year prior to evaluation and < 2 sessions (30 min or more) of volitional exercise per week. Volunteers will be ambulatory without the use of walking aids and living independently in the community. All participants will be required to obtain a physician's consent to participate in the study, due to the exercise component, as is common practice in the Department of Kinesiology.
Who cannot join
- History of major neurological or neuromuscular condition that may impact physical function, including cerebrovascular disease, peripheral neuropathy, neurodegenerative disease, demyelinating disease, cerebellar or extrapyramidal disease, etc.
- History of myocardial infarction, angina, peripheral vascular disease, surgical or percutaneous coronary artery revascularization
- History of severe pulmonary disease (i.e., dyspnea that limits activities of daily living such as household ambulation and self-care)
- History of rheumatoid arthritis
- History of diabetes or other metabolic disease that may impact neuromuscular function
- Uncontrolled hypertension (blood pressure > 140/90)
Show all 22Show fewer
- History of smoking in the past 1 year
- Moderate to severe lower extremity arthritis or pain (i.e., pain on level walking or that limits activities of daily living such as household ambulation and self-care)
- Pain, muscle cramps, joint stiffness, dyspnea, angina, light-headedness or other symptoms upon exertion
- The use of beta-blockers, sedatives, tranquilizers, or other medication that may impair physical function
- Individuals taking statin medications who report symptoms of muscle pain or myopathy
- Body-mass index >30 kg·m-2, as increased fat mass may alter single muscle fiber performance (Choi et al. J Gerontol A Biol Sci Med Sci 71:557-564, 2016)
- Body-mass index <18 kg·m-2, as this may be an early sign of frailty
- Must pass the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+, in Appendix)
- Any persons taking anti-coagulant medication or with known coagulapathies will be excluded, due to increased bleeding risk from biopsy procedure
- Participants with a contraindication for magnetic resonance testing, including a pace-maker or other implant
- Women will be postmenopausal, as defined as cessation of menses for at least 12 months prior to study
- Men and women undergoing hormone replacement therapy, because this treatment may circumvent normal age-related declines in sex hormone levels (if taken hormone therapy must have been > 5 years ago)
- Unintentional weight loss of greater than 2.5 kg during the last 3 months
- Currently participating in or have participated in a weight loss or exercise training program in the last year
- An inability to understand written and spoken English
- An inability to follow instructions, as determined by the investigators during the consenting process
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Massachusetts
Amherst, Massachusetts, 01003
Mark S Miller, PhD, 413-577-4701, markmiller@kin.umass.edu
About this study
Official title: Sex-specific Adaptation to Different Resistance Exercise Programs in Older Adults
In general, men and women experience differing degrees of age-related decreases in physical function, with women having a greater prevalence of functional limitations and disability. A key predictor of this decrease in functional capacity is the reduction in leg muscle maximal power (product of force and velocity), which can be improved with exercise training. However, the development of exercise interventions to optimally improve skeletal muscle function in older adults has been difficult, in part because we now know that men and women respond differently to the same exercise training stimulus. In fact, the fundamental mechanisms by which habitual exercise improves physical function in older adults are still not well understood. The proposed studies are designed to address these knowledge gaps by examining the molecular and cellular mechanisms underlying the response to two distinct exercise training paradigms, and determining how these responses differ between older men and women. The investigators hypothesize that molecular, cellular and whole muscle contractile performance will be most improved in men by traditional low-velocity, high-load resistance training, and in women by high-velocity, low-load power training. Moreover, sex-specific structural responses in myofilament remodeling, protein expression and post-translational modifications will explain these sex-specific performance adaptations to each modality. To test these hypotheses, data will be gathered from 50 healthy, sedentary older men and women (65-75 years) prior to and following a 16-week unilateral exercise training program in which one leg undergoes resistance training and the other power training. The Specific Aims of this project are to identify the sex-specific effects of low-velocity resistance training versus high-velocity power training on: Aim 1) skeletal muscle function at the molecular, cellular and whole muscle levels, and Aim 2) protein expression and modification as well as size at the molecular and cellular levels. The within subject, unilateral intervention design provides a powerful model to minimize the effects of between-subject variability, and the translational approach will take advantage of our unique expertise with state-of-the-art measures from the molecular to whole body levels.
- Conditions
- Biological Aging
- Being tested
- Resistance exercise training
- Keywords
- Resistance Training, Sex Differences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise trainingOther
16-week exercise training program, wherein one leg undergoes traditional low-velocity, high-load resistance training and the other leg undergoes high-velocity, low-load power training.
| Study group | Role | What they receive |
|---|---|---|
| Training | Other | All participants will participate in the 16-week resistance exercise training program. Receives: Other: Resistance exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak isokinetic power
Peak isokinetic power at the whole muscle level will be evaluated using a dynamometer.
Measured: This measure will be collected for each volunteer pre- and post-16 week exercise intervention and take approximately 30 minutes to collect for each time point.
Change in single fiber specific power
Single fiber specific power will be measured from segments of chemically-skinned single human skeletal muscle fibers under maximal calcium-activated conditions, with muscle fiber type determined post-measurement by gel electrophoresis
Measured: This measure will be preformed on tissue biopsied from each volunteer pre- and post-16 week exercise intervention and requires approximately 1 week to collect per time point.
Change in myosin attachment time
Myosin attachment time will be measured from segments of chemically-skinned single human skeletal muscle fibers under maximal calcium-activated conditions, with muscle fiber type determined post-measurement by gel electrophoresis.
Measured: This measure will be preformed on tissue biopsied from each volunteer pre- and post-16 week exercise intervention and requires approximately one week to collect per time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 Jan 2018
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological AgingStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vermont, National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Mark S Miller, PhD, Principal investigator, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440099
- Sponsor's protocol ID
- 116-1974
- Other IDs
- 1R01AG047245-01A1
- Status last verified
- May 2022
- First submitted
- 12 Jan 2018
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data will be considered for sharing under the rules indicated below. Raw datasets to be released for sharing will not contain identifiers. Data and associated documentation will be made available to users only under a signed and properly executed data-sharing agreement that provides for specific criteria under which the data will be used, including but not limited to a commitment to: 1) using the data only for research purposes; 2) securing the data using appropriate computer technology; and 3) destroying or returning the data after analyses are completed.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-specific Adaptation to Different Resistance Exercise Programs in Older Adults
- ClinicalTrials.gov ID
- NCT03440099
- Acronym / sponsor ID
- 116-1974
- Conditions
- Biological Aging
- Keywords
- Resistance Training, Sex Differences
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Collaborators
- University of Vermont, National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 20 Feb 2018 (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.
In general, men and women experience differing degrees of age-related decreases in physical function, with women having a greater prevalence of functional limitations and disability. A key predictor of this decrease in functional capacity is the reduction in leg muscle maximal power (product of force and velocity), which can be improved with exercise training. However, the development of exercise interventions to optimally improve skeletal muscle function in older adults has been difficult, in part because we now know that men and women respond differently to the same exercise training stimulus. In fact, the fundamental mechanisms by which habitual exercise improves physical function in older adults are still not well understood. The proposed studies are designed to address these knowledge gaps by examining the molecular and cellular mechanisms underlying the response to two distinct exercise training paradigms, and determining how these responses differ between older men and women. The investigators hypothesize that molecular, cellular and whole muscle contractile performance will be most improved in men by traditional low-velocity, high-load resistance training, and in women by high-velocity, low-load power training. Moreover, sex-specific structural responses in myofilament remodeling, protein expression and post-translational modifications will explain these sex-specific performance adaptations to each modality. To test these hypotheses, data will be gathered from 50 healthy, sedentary older men and women (65-75 years) prior to and following a 16-week unilateral exercise training program in which one leg undergoes resistance training and the other power training. The Specific Aims of this project are to identify the sex-specific effects of low-velocity resistance training versus high-velocity power training on: Aim 1) skeletal muscle function at the molecular, cellular and whole muscle levels, and Aim 2) protein expression and modification as well as size at the molecular and cellular levels. The within subject, unilateral intervention design provides a powerful model to minimize the effects of between-subject variability, and the translational approach will take advantage of our unique expertise with state-of-the-art measures from the molecular to whole body levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training | Other | Other: Resistance exercise trainingAll participants will participate in the 16-week resistance exercise training program. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Older adult (65-75 years old) volunteers will be healthy, by self-report, and sedentary, defined as no formal exercise program for the year prior to evaluation and < 2 sessions (30 min or more) of volitional exercise per week. Volunteers will be ambulatory without the use of walking aids and living independently in the community. All participants will be required to obtain a physician's consent to participate in the study, due to the exercise component, as is common practice in the Department of Kinesiology.
Key exclusion criteria (22 listed)
- History of major neurological or neuromuscular condition that may impact physical function, including cerebrovascular disease, peripheral neuropathy, neurodegenerative disease, demyelinating disease, cerebellar or extrapyramidal disease, etc.
- History of myocardial infarction, angina, peripheral vascular disease, surgical or percutaneous coronary artery revascularization
- History of severe pulmonary disease (i.e., dyspnea that limits activities of daily living such as household ambulation and self-care)
- History of rheumatoid arthritis
- History of diabetes or other metabolic disease that may impact neuromuscular function
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 |
|---|---|---|
| Resistance exercise training16-week exercise training program, wherein one leg undergoes traditional low-velocity, high-load resistance training and the other leg undergoes high-velocity, low-load power training. | Other | Training |
Primary outcome
Change in peak isokinetic power
Time frame: This measure will be collected for each volunteer pre- and post-16 week exercise intervention and take approximately 30 minutes to collect for each time point.
Peak isokinetic power at the whole muscle level will be evaluated using a dynamometer.
Change in single fiber specific power
Time frame: This measure will be preformed on tissue biopsied from each volunteer pre- and post-16 week exercise intervention and requires approximately 1 week to collect per time point.
Single fiber specific power will be measured from segments of chemically-skinned single human skeletal muscle fibers under maximal calcium-activated conditions, with muscle fiber type determined post-measurement by gel electrophoresis
Change in myosin attachment time
Time frame: This measure will be preformed on tissue biopsied from each volunteer pre- and post-16 week exercise intervention and requires approximately one week to collect per time point.
Myosin attachment time will be measured from segments of chemically-skinned single human skeletal muscle fibers under maximal calcium-activated conditions, with muscle fiber type determined post-measurement by gel electrophoresis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: Yes. Raw data will be considered for sharing under the rules indicated below. Raw datasets to be released for sharing will not contain identifiers. Data and associated documentation will be made available to users only under a signed and properly executed data-sharing agreement that provides for specific criteria under which the data will be used, including but not limited to a commitment to: 1) using the data only for research purposes; 2) securing the data using appropriate computer technology; and 3) destroying or returning the data after analyses are completed.
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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.
Mark S Miller, PhD principal investigator
University of Massachusetts, Amherst
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise training in people with Biological Aging, run by University of Massachusetts, Amherst 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 22 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 28 Jun 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark S Miller, PhD (4135774701, markmiller@kin.umass.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak isokinetic power (time frame: This measure will be collected for each volunteer pre- and post-16 week exercise intervention and take approximately 30 minutes to collect for each time point.). The study lists 3 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 28 Jun 2022.