SarcopeniaRESTORE-MENCT02628145
Effects of a Resistance Training Program in Older Women With Sarcopenia
A study testing Resistance Training Intervention in people with Sarcopenia, run by University of Rhode Island at 1 site in United States.
Trial summary
This is a randomized clinical trial with a control group that will test how periodized resistance training will impact measures of sarcopenia in older women who have been identified as presarcopenic or sarcopenic. The intervention will be approximately 12 weeks in duration with 24 total free-living older women. Read more about this study
- Who is it for?
- Ages 65 to 84 years, women only
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Resistance Training Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jul 2016
- 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 65 to 84 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Women, aged 65-84 years;
- Low lean mass and/or low physical functioning based on current guidelines;
- Currently (≥ 6 months) not engaged in a regular exercise program;
- Post-menopausal by self-report.
Who cannot join
- Failure to provide informed consent;
- Significant or suspected cognitive impairment;
- Severe hearing loss, speech disorder, language barrier or visual impairment;
- Progressive, degenerative neurologic disease;
- Terminal illness with life expectancy of < 12 months, as determined by a physician;
- Severe pulmonary disease, uncontrolled diabetes, blood pressure, or anemia;
Show all 10Show fewer
- Medications not taken for > 3 weeks, lipid lowering medications for > 6 months;
- Major joint, vascular, abdominal, or thoracic surgery within six months;
- Significant cardiovascular disease or implanted pacemaker/defibrillator;
- Inability to safely engage in mild to moderate exercise with muscular exertion.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rhode Island
Kingston, Rhode Island, 02881
About this study
This is a randomized clinical trial with a control group that will test how periodized resistance training will impact measures of sarcopenia in older women who have been identified as presarcopenic or sarcopenic. The intervention will be approximately 12 weeks in duration with 24 total free-living older women. Outcome measures will be collected at baseline, 6 weeks and post-intervention.
Read the detailed description
New sarcopenia (i.e. the age-related loss of muscle mass) guidelines established in 2014 recommend identifying older individuals for interventions who have low muscle strength and/or gait speed as these functional measures are associated with low muscle mass and subsequent negative health consequences such as increased mortality risk. Moreover, consensus guidelines indicate that more research, especially in older women, needs to be conducted to test the efficacy of periodized (i.e. planned variations in the program) resistance exercise training (RT) protocols in individuals who have been identified as sarcopenic or at risk of sarcopenia. Our interdisciplinary research group has conducted and published the results of several intervention studies in older adults and would like to expand this line of research to fill a critical gap in the current research. The broad objective of this research project is to help determine the efficacy of a periodized RT intervention strategy to treat sarcopenia or presarcopenia and its correlates among older women. The specific primary aim is to determine if there is significant effect of a RT program for improving physical functioning and muscle mass in older women. Exploratory aims are determine the impact of the RT intervention on other measures including bone density, lipoproteins, and other health indicators. The long-term goal of this project is to generate essential data for the submission of a more comprehensive NIH or private agency grant. The research design will be a randomized trial with a control group and methodology of this study will include 25 community-dwelling older women (age 65-84 years) for a 12-week repeated measures (baseline, 6 week, and post) randomized study with a six month observational follow-up. After baseline testing, participants will be randomized to either a RT intervention group (RTI) or to an active control (CON) group. The RT intervention will take place three times per week on non-consecutive days using 8-10 exercises for major muscle groups utilizing free weights and machines follow American College of Sports Medicine and National Strength and Conditioning Association guidelines for RT in older adults. The CON group will meet three times weekly for light physical activity and stretching. The relevance of this research is very significant as no studies to date have specifically examined RT in older women who have been identified as sarcopenic or presarcopenic using newly established guidelines. This study will accept all potential participants meeting inclusion criteria, regardless of ethnic, racial, or religious backgrounds.
- Conditions
- Sarcopenia
- Being tested
- Resistance Training Intervention, Active Control Group
- Keywords
- Sarcopenia, aging, resistance training, physical functioning
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training InterventionBehavioural
The RTI group will participate in a periodized RT program on 3 non-consecutive days/week using NSCA and ACSM guidelines and will be designed by a team member who is a NSCA certified strength and conditioning specialist. This program will consist of a full-body, nonlinear periodized program: a training method that has frequent variations in program variables. Intensity variations intensity are based on training phase. E.g., the first portion of 12-week cycle has more moderate and light days as participants adapt to the program. Weeks 1-4 will consist of primarily RT machine exercises and few unilateral and multi-joint light free weight exercise. Weeks 5-8 will incorporate more free-weight exercises that are multi-joint. Weeks 9-12 will incorporate more complex multi-joint movements.
Active Control GroupBehavioural
The CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training Intervention | Experimental | The RT intervention will take place three times per week for approximately 12 weeks on non-consecutive days using 8-10 exercises for major muscle groups utilizing free weights and machines follow American College of Sports Medicine and National Strength and Conditioning Association guidelines for RT in older adults. Receives: Behavioral: Resistance Training Intervention |
| Active Control Group | Active comparator | The CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching. Receives: Behavioral: Active Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Mass Change: From Dual Energy X-ray Absorptiometry and Bioelectrical Impedance Analsysis - Appendicular Lean Mass (ALM in kg) Divided by Height (Meters-squared)
Overall body composition was estimated using dual-energy x-ray absorptiometry (DXA) using fan-beam technology on a GE Lunar iDXA machine (GE, Waukesha, WI). Participants reported to testing in a fasted state (~12 hours) and wore surgical scrubs during the test. Standardized positioning procedures were followed and a licensed radiology technician performed all tests. Appendicular lean mass, total body fat mass, and percent fat were measured. Appendicular lean mass was considered the sum of non-bone lean mass in both arms and legs. Total body lean mass was defined as lean soft tissue mass plus total body bone mineral content.
Measured: 12 weeks
Secondary outcomes (9)
Sarcopenia Status Change
The multiple measurements will be aggregated to arrive at one reported value of change in the number of sarcopenic women using the International Working Group on Sarcopenia guidelines. Appendicular lean mass divided by height in meters squared <5.67 and gait speed of <1.0 meters per second indicates sarcopenia present. Change in status in 12 weeks indicates 1) stayed sarcopenic, 2) stayed non-sarcopenic, 3), became sarcopenic, or 4) became non-sarcopenic.
Measured: 12 weeks
Balance Ability: Single-leg Stand. Scored Yes or No
Yes is a good outcome to be able to stand on one leg for 10 seconds. Categories for change in this in this ability are 1) Maintained Single Leg Stand Ability, 2) Maintained Single Leg Stand Inability, 3) Developed Single Leg Stand Ability, 4) Lost Single Leg Stand Ability.
Measured: 12 weeks
Mobility Change: 8 Foot Timed up and go From a Seated Position Around a Cone Back to a Seated Position
Measured: 12 weeks
Hip Bone Mineral Density: Measured by Dual Energy X-ray Absorptiometry
Measured: 12 weeks
Physical Functioning Change: Normal Gait Speed Time From 400-meter Walk
Change in timed 400-meter walk in seconds doing laps in a measured corridor at a pace that the participant can maintain.
Measured: 6 weeks, 12 weeks, and six month follow-up
Grip Strength Change: From Hand Grip Dynamometry in kg
Handgrip strength was measured in both hands with the participant in a seated position using a handgrip dynamometer and standardized protocols (Jamar Hydraulic Dynamometer, J.A. Preston, Corp., Jackson, MS). Two trials per hand were completed and the highest score measured was used for sarcopenia classification.
Measured: 6 weeks, 12 weeks, and six month follow-up
Muscle Strength Change: Leg Press One-repetition Maximum in kg
All participants completed a familiarization with leg press machine one week prior to strength testing. Participants completed a set of 3-5 repetitions on the machine using a load determined by the participant to be comfortable, then a second set of 3-5 repetitions at an increased intensity, followed by 1-3 sets of progressively increasing intensity until the participant reached 80-90% of their maximal effort as rated on the Borg CR-10 scale. Maximal leg press strength was assessed using previously published methods on Cybex seated leg press machine (Cybex International Inc., Medway, MA). Participants completed a dynamic warm-up prior to strength testing. The leg press test required the participant to extend their knees from a starting position of ~90 degrees until the legs are fully extended, but not locked at the knees.
Measured: 6 weeks, 12 weeks, and six month follow-up
Chair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair
Measured: 6 weeks, 12 weeks, and six month follow-up
Chair Stand Ability: Ability to Rise From a Chair One Time - Yes or No
Chair stand ability: ability to rise from a chair one time - Yes or No, with "Yes" being a positive outcome. Two categories: 1) Able to Rise from a Chair and 2) Unable to Rise from a Chair
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionJul 2016
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.
- Other trials for SarcopeniaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J. Delmonico, PhD, MPH, University of Rhode Island
- Investigators
- Mattthew J Delmonico, PhD, Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628145
- Sponsor's protocol ID
- HU1415-168
- Acronym
- RESTORE-ME
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2015
- Last updated
- 4 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Resistance Training Program in Older Women With Sarcopenia
- ClinicalTrials.gov ID
- NCT02628145
- Acronym / sponsor ID
- RESTORE-ME / HU1415-168
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, aging, resistance training, physical functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Posted 4 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized clinical trial with a control group that will test how periodized resistance training will impact measures of sarcopenia in older women who have been identified as presarcopenic or sarcopenic. The intervention will be approximately 12 weeks in duration with 24 total free-living older women. Outcome measures will be collected at baseline, 6 weeks and post-intervention.
Detailed description
New sarcopenia (i.e. the age-related loss of muscle mass) guidelines established in 2014 recommend identifying older individuals for interventions who have low muscle strength and/or gait speed as these functional measures are associated with low muscle mass and subsequent negative health consequences such as increased mortality risk. Moreover, consensus guidelines indicate that more research, especially in older women, needs to be conducted to test the efficacy of periodized (i.e. planned variations in the program) resistance exercise training (RT) protocols in individuals who have been identified as sarcopenic or at risk of sarcopenia. Our interdisciplinary research group has conducted and published the results of several intervention studies in older adults and would like to expand this line of research to fill a critical gap in the current research. The broad objective of this research project is to help determine the efficacy of a periodized RT intervention strategy to treat sarcopenia or presarcopenia and its correlates among older women. The specific primary aim is to determine if there is significant effect of a RT program for improving physical functioning and muscle mass in older women. Exploratory aims are determine the impact of the RT intervention on other measures including bone density, lipoproteins, and other health indicators. The long-term goal of this project is to generate essential data for the submission of a more comprehensive NIH or private agency grant. The research design will be a randomized trial with a control group and methodology of this study will include 25 community-dwelling older women (age 65-84 years) for a 12-week repeated measures (baseline, 6 week, and post) randomized study with a six month observational follow-up. After baseline testing, participants will be randomized to either a RT intervention group (RTI) or to an active control (CON) group. The RT intervention will take place three times per week on non-consecutive days using 8-10 exercises for major muscle groups utilizing free weights and machines follow American College of Sports Medicine and National Strength and Conditioning Association guidelines for RT in older adults. The CON group will meet three times weekly for light physical activity and stretching. The relevance of this research is very significant as no studies to date have specifically examined RT in older women who have been identified as sarcopenic or presarcopenic using newly established guidelines. This study will accept all potential participants meeting inclusion criteria, regardless of ethnic, racial, or religious backgrounds.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Training Intervention | Experimental | Behavioral: Resistance Training InterventionThe RT intervention will take place three times per week for approximately 12 weeks on non-consecutive days using 8-10 exercises for major muscle groups utilizing free weights and machines follow American College of Sports Medicine and National Strength and Conditioning Association guidelines for RT in older adults. |
| Active Control Group | Active comparator | Behavioral: Active Control GroupThe CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Women, aged 65-84 years;
- Low lean mass and/or low physical functioning based on current guidelines;
- Currently (≥ 6 months) not engaged in a regular exercise program;
- Post-menopausal by self-report.
Key exclusion criteria (10 listed)
- Failure to provide informed consent;
- Significant or suspected cognitive impairment;
- Severe hearing loss, speech disorder, language barrier or visual impairment;
- Progressive, degenerative neurologic disease;
- Terminal illness with life expectancy of < 12 months, as determined by a physician;
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 InterventionThe RTI group will participate in a periodized RT program on 3 non-consecutive days/week using NSCA and ACSM guidelines and will be designed by a team member who is a NSCA certified strength and conditioning specialist. This program will consist of a full-body, nonlinear periodized program: a training method that has frequent variations in program variables. Intensity variations intensity are based on training phase. E.g., the first portion of 12-week cycle has more moderate and light days as participants adapt to the program. Weeks 1-4 will consist of primarily RT machine exercises and few unilateral and multi-joint light free weight exercise. Weeks 5-8 will incorporate more free-weight exercises that are multi-joint. Weeks 9-12 will incorporate more complex multi-joint movements. | Behavioural | Resistance Training Intervention |
| Active Control GroupThe CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching. | Behavioural | Active Control Group |
Primary outcome
Muscle Mass Change: From Dual Energy X-ray Absorptiometry and Bioelectrical Impedance Analsysis - Appendicular Lean Mass (ALM in kg) Divided by Height (Meters-squared)
Time frame: 12 weeks
Overall body composition was estimated using dual-energy x-ray absorptiometry (DXA) using fan-beam technology on a GE Lunar iDXA machine (GE, Waukesha, WI). Participants reported to testing in a fasted state (~12 hours) and wore surgical scrubs during the test. Standardized positioning procedures were followed and a licensed radiology technician performed all tests. Appendicular lean mass, total body fat mass, and percent fat were measured. Appendicular lean mass was considered the sum of non-bone lean mass in both arms and legs. Total body lean mass was defined as lean soft tissue mass plus total body bone mineral content.
9 secondary outcomes
Sarcopenia Status Change
Time frame: 12 weeks
Balance Ability: Single-leg Stand. Scored Yes or No
Time frame: 12 weeks
Mobility Change: 8 Foot Timed up and go From a Seated Position Around a Cone Back to a Seated Position
Time frame: 12 weeks
Hip Bone Mineral Density: Measured by Dual Energy X-ray Absorptiometry
Time frame: 12 weeks
Physical Functioning Change: Normal Gait Speed Time From 400-meter Walk
Time frame: 6 weeks, 12 weeks, and six month follow-up
Grip Strength Change: From Hand Grip Dynamometry in kg
Time frame: 6 weeks, 12 weeks, and six month follow-up
Muscle Strength Change: Leg Press One-repetition Maximum in kg
Time frame: 6 weeks, 12 weeks, and six month follow-up
Chair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair
Time frame: 6 weeks, 12 weeks, and six month follow-up
Chair Stand Ability: Ability to Rise From a Chair One Time - Yes or No
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Mattthew J Delmonico, PhD principal investigator
University of Rhode Island
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 Intervention in people with Sarcopenia, run by University of Rhode Island 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 4 inclusion and 10 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 4 Oct 2023. 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 4 Oct 2023). 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?
Muscle Mass Change: From Dual Energy X-ray Absorptiometry and Bioelectrical Impedance Analsysis - Appendicular Lean Mass (ALM in kg) Divided by Height (Meters-squared) (time frame: 12 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 4 Oct 2023.