AgingNCT02442479
Maximizing Mechanisms of Muscle Hypertrophy to Combat Sarcopenia in Older Adults
A study testing resistance training in people with Aging and Muscular Atrophy, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Resistance training has shown the most promise among interventions aimed to combat aging muscle atrophy as it enhances strength, power, and mobility function, but induces varying degrees of skeletal muscle hypertrophy as the investigators demonstrated in the initial 5-year funding period of this award (2001-2006). Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Muscular Atrophy
- What is being tested?
- resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Mar 2013
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60-75 years of age; BMI less than or equal to 30; passed comprehensive physical examination including resting electrocardiogram and a diagnostic graded exercise stress test with 12-lead electrocardiogram; able to exercise on a treadmill for 10 minutes; (female participants) at least 5 years post-menopausal.
Who cannot join
- Neurological, musculoskeletal, or other disorder that would preclude completing resistance training and all performance tests; uncontrolled hypertension, unstable or exercise-induced angina pectoris or myocardial ischemia; diabetes mellitus; pregnancy; any other medical condition that would interfere with testing or increase one's risk of complications during exercise; lidocaine allergy; prescription anti-coagulants (e.g., Coumadin); current androgen or anabolic (e.g., GH, IGF-I) therapy; food allergy to cow's milk; history of regular resistance exercise during the previous 3 years; any contraindications to magnetic resonance imaging including pacemakers, aneurysm clips, or any other ferrous metal implants; current adherence to a weight reduction diet.
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Center for Exercise Medicine
Birmingham, Alabama, 35294
About this study
Resistance training has shown the most promise among interventions aimed to combat aging muscle atrophy as it enhances strength, power, and mobility function, but induces varying degrees of skeletal muscle hypertrophy as the investigators demonstrated in the initial 5-year funding period of this award (2001-2006). In the subsequent 5-year funding period (2007-2012), the investigators built on this prior work by using a dose-response approach in older adults - ultimately to optimize the treatment of age-related muscle atrophy. The investigators tested four, long-term resistance training prescriptions in older (60-75 yr) women and men to determine which prescription maximizes mechanisms driving muscle regrowth. One of the innovations in this project was the use of a 4-wk pre-training program to reach a plateau in the early, non-muscle mass adaptations, thereby establishing a true baseline from which both mechanisms of measurable muscle hypertrophy and functional consequences of hypertrophy could be studied in a tightly integrated fashion without bias in the subsequent experimental period. A randomized design was used to test the overarching hypothesis that a novel program of mixed strength and power training would optimize the anabolic environment to promote muscle hypertrophy and robust gains in performance. This hypothesis was tested with three specific aims.
Read the detailed description
Resistance training has shown the most promise among interventions aimed to combat aging muscle atrophy as it enhances strength, power, and mobility function, but induces varying degrees of skeletal muscle hypertrophy as we demonstrated in the initial 5-year funding period of this award (2001-2006). In the subsequent 5-year funding period (2007-2012), we built on this prior work by using a dose-response approach in older adults - ultimately to optimize the treatment of age-related muscle atrophy. We tested four, long-term resistance training prescriptions in older (60-75 yr) women and men to determine which prescription maximizes mechanisms driving muscle regrowth (protein synthesis and myonuclear addition). One of the innovations in this project was the use of a 4-wk pre-training program to reach a plateau in the early, non-muscle mass adaptations, thereby establishing a true baseline from which both mechanisms of measurable muscle hypertrophy and functional consequences of hypertrophy could be studied in a tightly integrated fashion without bias in the subsequent experimental period. A randomized design was used to test the overarching hypothesis that a novel program of mixed strength and power training would optimize the anabolic environment to promote muscle hypertrophy and robust gains in performance. This hypothesis was tested with three specific aims.
Specific Aim 1. We determined the effects of manipulating intensity, recovery, and mode of contraction on rates of muscle hypertrophy and muscle mass-dependent improvements in tests of in vivo muscle performance among older women and men. In brief, the four training models were: (1) traditional high-resistance concentric-eccentric training (H) 3 d/wk (HHH3); (2) high-resistance concentric-eccentric training 2 d/wk (HH2); (3) 3 d/wk mixed model consisting of high-resistance concentric-eccentric training 2 d/wk separated by 1 bout of low-resistance, high-velocity, concentric only training (L) (HLH3); and (4) 2 d/wk mixed model consisting of high-resistance concentric-eccentric training 1 d/wk and low-resistance, high-velocity, concentric only training 1 d/wk (HL2). For Aim 1, we hypothesized that the HLH3 prescription would prove optimal overall for combined gains in muscle mass, strength, power, and fatigue resistance in both women and men, while HL2 would be the least effective program due to insufficient weekly loading.
Specific Aim 2. Myofiber hypertrophy requires net muscle protein synthesis, and advanced fiber expansion is facilitated by nuclear addition. We are conducting a comprehensive evaluation of: (1) key regulatory steps in the protein synthesis/degradation machinery; and (2) myonuclear addition and satellite cell activation/cell cycle regulation. Quantitative relationships between metabolic/molecular responses and the magnitude of muscle hypertrophy among older adults will enable us to identify underlying factors that respond differently to these four resistance training models, potentially in a gender-specific manner, thus revealing important processes that drive the hypertrophy adaptation. We hypothesized that muscle protein synthesis and myonuclear addition, along with key underlying regulatory processes, would be most favorably affected by the work-recovery cycle of 2 d/wk high-resistance loading (HLH3 and HH2 models), thereby optimizing the anabolic environment for muscle hypertrophy in both older women and men.
Specific Aim 3. To translate the findings under Aim 1 to clinically important outcomes, we determined the degree to which non-traditional resistance training programs lead to improvements in mobility function and weight-bearing exercise difficulty. We hypothesized that a less stressful weekly training regimen consisting of fewer high-resistance contractions (HLH3) and/or fewer training sessions (HH2) while achieving substantial hypertrophy would promote equal or better improvements in mobility function and weight-bearing exercise difficulty than the traditionally prescribed HHH3 program.
- Conditions
- Aging, Muscular Atrophy
- Being tested
- resistance training
- Keywords
- exercise, resistance training, muscle strength, muscle hypertrophy
- Medical subject headings
- Muscular Atrophy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| HHH3 | Active comparator | High-resistance concentric-eccentric training (H) 3 d/wk (HHH3). Receives: Behavioral: resistance training |
| HLH3 | Experimental | 3 d/wk mixed model consisting of high-resistance concentric-eccentric training 2 d/wk separated by 1 bout of low-resistance, high-velocity, concentric only training (L) (HLH3). Receives: Behavioral: resistance training |
| HH2 | Experimental | High-resistance concentric-eccentric training 2 d/wk (HH2). Receives: Behavioral: resistance training |
| HL2 | Experimental | 2 d/wk mixed model consisting of high-resistance concentric-eccentric training 1 d/wk and low-resistance, high-velocity, concentric only training 1 d/wk (HL2). Receives: Behavioral: resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass
DXA-determined lean mass and thigh muscle mass
Measured: Change from baseline at week 35
Secondary outcomes (3)
vastus lateralis muscle fiber size
type I and type II muscle fiber size by immunofluorescence microscopy
Measured: Change from baseline at week 35
maximum strength
one-repetition maximum voluntary strength
Measured: Change from baseline at week 35
maximum power
knee extension power
Measured: Change from baseline at week 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startApr 2007
- Primary completionMar 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), US Dairy Export Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442479
- Sponsor's protocol ID
- 5R01AG017896
- Status last verified
- May 2015
- First submitted
- 6 May 2015
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Stec MJ, Thalacker-Mercer A, Mayhew DL, Kelly NA, Tuggle SC, Merritt EK, Brown CJ, Windham ST, Dell'Italia LJ, Bickel CS, Roberts BM, Vaughn KM, Isakova-Donahue I, Many GM, Bamman MM. Randomized, four-arm, dose-response clinical trial to optimize resistance exercise training for older adults with age-related muscle atrophy. Exp Gerontol. 2017 Dec 1;99:98-109. doi: 10.1016/j.exger.2017.09.018. Epub 2017 Sep 28.
PubMed 28964826
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Mechanisms of Muscle Hypertrophy to Combat Sarcopenia in Older Adults
- ClinicalTrials.gov ID
- NCT02442479
- Acronym / sponsor ID
- 5R01AG017896
- Conditions
- Aging, Muscular Atrophy
- Keywords
- exercise, resistance training, muscle strength, muscle hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), US Dairy Export Council
- Study start
- Apr 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 May 2015 (estimated)
- 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.
Resistance training has shown the most promise among interventions aimed to combat aging muscle atrophy as it enhances strength, power, and mobility function, but induces varying degrees of skeletal muscle hypertrophy as the investigators demonstrated in the initial 5-year funding period of this award (2001-2006). In the subsequent 5-year funding period (2007-2012), the investigators built on this prior work by using a dose-response approach in older adults - ultimately to optimize the treatment of age-related muscle atrophy. The investigators tested four, long-term resistance training prescriptions in older (60-75 yr) women and men to determine which prescription maximizes mechanisms driving muscle regrowth. One of the innovations in this project was the use of a 4-wk pre-training program to reach a plateau in the early, non-muscle mass adaptations, thereby establishing a true baseline from which both mechanisms of measurable muscle hypertrophy and functional consequences of hypertrophy could be studied in a tightly integrated fashion without bias in the subsequent experimental period. A randomized design was used to test the overarching hypothesis that a novel program of mixed strength and power training would optimize the anabolic environment to promote muscle hypertrophy and robust gains in performance. This hypothesis was tested with three specific aims.
Detailed description
Resistance training has shown the most promise among interventions aimed to combat aging muscle atrophy as it enhances strength, power, and mobility function, but induces varying degrees of skeletal muscle hypertrophy as we demonstrated in the initial 5-year funding period of this award (2001-2006). In the subsequent 5-year funding period (2007-2012), we built on this prior work by using a dose-response approach in older adults - ultimately to optimize the treatment of age-related muscle atrophy. We tested four, long-term resistance training prescriptions in older (60-75 yr) women and men to determine which prescription maximizes mechanisms driving muscle regrowth (protein synthesis and myonuclear addition). One of the innovations in this project was the use of a 4-wk pre-training program to reach a plateau in the early, non-muscle mass adaptations, thereby establishing a true baseline from which both mechanisms of measurable muscle hypertrophy and functional consequences of hypertrophy could be studied in a tightly integrated fashion without bias in the subsequent experimental period. A randomized design was used to test the overarching hypothesis that a novel program of mixed strength and power training would optimize the anabolic environment to promote muscle hypertrophy and robust gains in performance. This hypothesis was tested with three specific aims.
Specific Aim 1. We determined the effects of manipulating intensity, recovery, and mode of contraction on rates of muscle hypertrophy and muscle mass-dependent improvements in tests of in vivo muscle performance among older women and men. In brief, the four training models were: (1) traditional high-resistance concentric-eccentric training (H) 3 d/wk (HHH3); (2) high-resistance concentric-eccentric training 2 d/wk (HH2); (3) 3 d/wk mixed model consisting of high-resistance concentric-eccentric training 2 d/wk separated by 1 bout of low-resistance, high-velocity, concentric only training (L) (HLH3); and (4) 2 d/wk mixed model consisting of high-resistance concentric-eccentric training 1 d/wk and low-resistance, high-velocity, concentric only training 1 d/wk (HL2). For Aim 1, we hypothesized that the HLH3 prescription would prove optimal overall for combined gains in muscle mass, strength, power, and fatigue resistance in both women and men, while HL2 would be the least effective program due to insufficient weekly loading.
Specific Aim 2. Myofiber hypertrophy requires net muscle protein synthesis, and advanced fiber expansion is facilitated by nuclear addition. We are conducting a comprehensive evaluation of: (1) key regulatory steps in the protein synthesis/degradation machinery; and (2) myonuclear addition and satellite cell activation/cell cycle regulation. Quantitative relationships between metabolic/molecular responses and the magnitude of muscle hypertrophy among older adults will enable us to identify underlying factors that respond differently to these four resistance training models, potentially in a gender-specific manner, thus revealing important processes that drive the hypertrophy adaptation. We hypothesized that muscle protein synthesis and myonuclear addition, along with key underlying regulatory processes, would be most favorably affected by the work-recovery cycle of 2 d/wk high-resistance loading (HLH3 and HH2 models), thereby optimizing the anabolic environment for muscle hypertrophy in both older women and men.
Specific Aim 3. To translate the findings under Aim 1 to clinically important outcomes, we determined the degree to which non-traditional resistance training programs lead to improvements in mobility function and weight-bearing exercise difficulty. We hypothesized that a less stressful weekly training regimen consisting of fewer high-resistance contractions (HLH3) and/or fewer training sessions (HH2) while achieving substantial hypertrophy would promote equal or better improvements in mobility function and weight-bearing exercise difficulty than the traditionally prescribed HHH3 program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HHH3 | Active comparator | Behavioral: resistance trainingHigh-resistance concentric-eccentric training (H) 3 d/wk (HHH3). |
| HLH3 | Experimental | Behavioral: resistance training3 d/wk mixed model consisting of high-resistance concentric-eccentric training 2 d/wk separated by 1 bout of low-resistance, high-velocity, concentric only training (L) (HLH3). |
| HH2 | Experimental | Behavioral: resistance trainingHigh-resistance concentric-eccentric training 2 d/wk (HH2). |
| HL2 | Experimental | Behavioral: resistance training2 d/wk mixed model consisting of high-resistance concentric-eccentric training 1 d/wk and low-resistance, high-velocity, concentric only training 1 d/wk (HL2). |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 60-75 years of age; BMI less than or equal to 30; passed comprehensive physical examination including resting electrocardiogram and a diagnostic graded exercise stress test with 12-lead electrocardiogram; able to exercise on a treadmill for 10 minutes; (female participants) at least 5 years post-menopausal.
Key exclusion criteria (1 listed)
- Neurological, musculoskeletal, or other disorder that would preclude completing resistance training and all performance tests; uncontrolled hypertension, unstable or exercise-induced angina pectoris or myocardial ischemia; diabetes mellitus; pregnancy; any other medical condition that would interfere with testing or increase one's risk of complications during exercise; lidocaine allergy; prescription anti-coagulants (e.g., Coumadin); current androgen or anabolic (e.g., GH, IGF-I) therapy; food allergy to cow's milk; history of regular resistance exercise during the previous 3 years; any contraindications to magnetic resonance imaging including pacemakers, aneurysm clips, or any other ferrous metal implants; current adherence to a weight reduction diet.
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 training | Behavioural | HH2, HHH3, HL2, HLH3 |
Primary outcome
muscle mass
Time frame: Change from baseline at week 35
DXA-determined lean mass and thigh muscle mass
3 secondary outcomes
vastus lateralis muscle fiber size
Time frame: Change from baseline at week 35
maximum strength
Time frame: Change from baseline at week 35
maximum power
Time frame: Change from baseline at week 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Derived from this study: PubMed 28964826Stec MJ, Thalacker-Mercer A, Mayhew DL, Kelly NA, Tuggle SC, Merritt EK, Brown CJ, Windham ST, Dell'Italia LJ, Bickel CS, Roberts BM, Vaughn KM, Isakova-Donahue I, Many GM, Bamman MM. Randomized, four-arm, dose-response clinical trial to optimize resistance exercise training for older adults with age-related muscle atrophy. Exp Gerontol. 2017 Dec 1;99:98-109. doi: 10.1016/j.exger.2017.09.018. Epub 2017 Sep 28.
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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 resistance training in people with Aging and Muscular Atrophy, run by University of Alabama at Birmingham 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: finished, as of the sponsor's last update on 25 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Change from baseline at week 35). 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 NCT02442479, which also lists 1 linked publication.
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 25 Apr 2016.