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Effects of a Resistance Training Program in Older Women With Sarcopenia

Effects of a Resistance Training Program in Older Women With Sarcopenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02628145
Acronym
RESTORE-ME
Enrollment
25
Registered
2015-12-11
Start date
2015-08-31
Completion date
2016-07-31
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenia

Keywords

Sarcopenia, aging, resistance training, physical functioning

Brief 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. 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.

Interventions

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.

BEHAVIORALActive Control Group

The CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching.

Sponsors

University of Rhode Island
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
65 Years to 84 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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; * 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.

Design outcomes

Primary

MeasureTime frameDescription
Muscle Mass Change: From Dual Energy X-ray Absorptiometry and Bioelectrical Impedance Analsysis - Appendicular Lean Mass (ALM in kg) Divided by Height (Meters-squared)12 weeksOverall 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.

Secondary

MeasureTime frameDescription
Hip Bone Mineral Density: Measured by Dual Energy X-ray Absorptiometry12 weeks
Muscle Strength Change: Leg Press One-repetition Maximum in kg6 weeks, 12 weeks, and six month follow-upAll 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.
Chair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair6 weeks, 12 weeks, and six month follow-up
Chair Stand Ability: Ability to Rise From a Chair One Time - Yes or NoBaselineChair 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
Sarcopenia Status Change12 weeksThe 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.
Balance Ability: Single-leg Stand. Scored Yes or No12 weeksYes 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.
Mobility Change: 8 Foot Timed up and go From a Seated Position Around a Cone Back to a Seated Position12 weeks
Physical Functioning Change: Normal Gait Speed Time From 400-meter Walk6 weeks, 12 weeks, and six month follow-upChange in timed 400-meter walk in seconds doing laps in a measured corridor at a pace that the participant can maintain.
Grip Strength Change: From Hand Grip Dynamometry in kg6 weeks, 12 weeks, and six month follow-upHandgrip 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.

Other

MeasureTime frameDescription
HeightBaseline onlyHeight, measured in cm from a stadiometer
Body Mass, Baseline Only.baselineBody mass in kg as measured from a balance-beam scale.
Body Mass Index Change: Weight in kg Divided by Height12 weeks

Countries

United States

Participant flow

Participants by arm

ArmCount
Resistance Training Intervention
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. Resistance Training Intervention: 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.
13
Active Control Group
The CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching. Active Control Group: The CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching.
12
Total25

Baseline characteristics

CharacteristicActive Control GroupTotalResistance Training Intervention
Age, Continuous72.9 years
STANDARD_DEVIATION 4.6
72.3 years
STANDARD_DEVIATION 4.6
71.8 years
STANDARD_DEVIATION 4.8
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
12 Participants25 Participants13 Participants
Sex: Female, Male
Female
12 Participants25 Participants13 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 12
other
Total, other adverse events
0 / 130 / 12
serious
Total, serious adverse events
0 / 130 / 12

Outcome results

Primary

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.

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
Resistance Training InterventionMuscle Mass Change: From Dual Energy X-ray Absorptiometry and Bioelectrical Impedance Analsysis - Appendicular Lean Mass (ALM in kg) Divided by Height (Meters-squared)0.09 kg/m2Standard Error 0.08
Active Control GroupMuscle Mass Change: From Dual Energy X-ray Absorptiometry and Bioelectrical Impedance Analsysis - Appendicular Lean Mass (ALM in kg) Divided by Height (Meters-squared)0.10 kg/m2Standard Error 0.09
p-value: 0.91Mixed Models Analysis
Secondary

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.

Time frame: 12 weeks

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Resistance Training InterventionBalance Ability: Single-leg Stand. Scored Yes or NoMaintained Single Leg Stand Ability5 Participants
Resistance Training InterventionBalance Ability: Single-leg Stand. Scored Yes or NoMaintained Single Leg Stand Inability3 Participants
Resistance Training InterventionBalance Ability: Single-leg Stand. Scored Yes or NoDeveloped Single Leg Stand Ability3 Participants
Resistance Training InterventionBalance Ability: Single-leg Stand. Scored Yes or NoLost Single Leg Stand Ability.1 Participants
Active Control GroupBalance Ability: Single-leg Stand. Scored Yes or NoLost Single Leg Stand Ability.0 Participants
Active Control GroupBalance Ability: Single-leg Stand. Scored Yes or NoMaintained Single Leg Stand Ability4 Participants
Active Control GroupBalance Ability: Single-leg Stand. Scored Yes or NoDeveloped Single Leg Stand Ability2 Participants
Active Control GroupBalance Ability: Single-leg Stand. Scored Yes or NoMaintained Single Leg Stand Inability4 Participants
p-value: 0.068Fisher Exact
Secondary

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

Time frame: Baseline

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Resistance Training InterventionChair Stand Ability: Ability to Rise From a Chair One Time - Yes or NoAble to Rise from a Chair12 Participants
Resistance Training InterventionChair Stand Ability: Ability to Rise From a Chair One Time - Yes or NoUnable to Rise from a Chair0 Participants
Active Control GroupChair Stand Ability: Ability to Rise From a Chair One Time - Yes or NoAble to Rise from a Chair10 Participants
Active Control GroupChair Stand Ability: Ability to Rise From a Chair One Time - Yes or NoUnable to Rise from a Chair0 Participants
Secondary

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

Population: Missing data or participants chose not to be retested.

ArmMeasureGroupValue (MEAN)Dispersion
Resistance Training InterventionChair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair6 weeks-0.95 secondsStandard Error 0.78
Resistance Training InterventionChair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair12 weeks-1.56 secondsStandard Error 1.05
Resistance Training InterventionChair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chairsix month follow-up-1.13 secondsStandard Error 0.88
Active Control GroupChair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair6 weeks-1.05 secondsStandard Error 0.9
Active Control GroupChair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair12 weeks-2.39 secondsStandard Error 1.1
Active Control GroupChair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chairsix month follow-up-2.70 secondsStandard Error 1
p-value: >0.05Mixed Models Analysis
Secondary

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.

Time frame: 6 weeks, 12 weeks, and six month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Resistance Training InterventionGrip Strength Change: From Hand Grip Dynamometry in kgsix month follow up0.25 kgStandard Error 0.95
Resistance Training InterventionGrip Strength Change: From Hand Grip Dynamometry in kg12 weeks1.67 kgStandard Error 1.03
Resistance Training InterventionGrip Strength Change: From Hand Grip Dynamometry in kg6 weeks1.08 kgStandard Error 0.9
Active Control GroupGrip Strength Change: From Hand Grip Dynamometry in kg12 weeks0.50 kgStandard Error 1.26
Active Control GroupGrip Strength Change: From Hand Grip Dynamometry in kg6 weeks1.45 kgStandard Error 1.03
Active Control GroupGrip Strength Change: From Hand Grip Dynamometry in kgsix month follow up-0.10 kgStandard Error 1.04
p-value: >0.05Mixed Models Analysis
Secondary

Hip Bone Mineral Density: Measured by Dual Energy X-ray Absorptiometry

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
Resistance Training InterventionHip Bone Mineral Density: Measured by Dual Energy X-ray Absorptiometry-0.0005 g/m2Standard Deviation 0.0197
Active Control GroupHip Bone Mineral Density: Measured by Dual Energy X-ray Absorptiometry0.0105 g/m2Standard Deviation 0.0548
p-value: 0.52Mixed Models Analysis
Secondary

Mobility Change: 8 Foot Timed up and go From a Seated Position Around a Cone Back to a Seated Position

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
Resistance Training InterventionMobility Change: 8 Foot Timed up and go From a Seated Position Around a Cone Back to a Seated Position-0.48 secondsStandard Error 0.25
Active Control GroupMobility Change: 8 Foot Timed up and go From a Seated Position Around a Cone Back to a Seated Position-0.74 secondsStandard Error 0.27
p-value: 0.48Mixed Models Analysis
Secondary

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.

Time frame: 6 weeks, 12 weeks, and six month follow-up

Population: Two participants from each group chose not to be retested.

ArmMeasureGroupValue (MEAN)Dispersion
Resistance Training InterventionMuscle Strength Change: Leg Press One-repetition Maximum in kg6 weeks13.35 kgStandard Error 2.71
Resistance Training InterventionMuscle Strength Change: Leg Press One-repetition Maximum in kg12 weeks20.85 kgStandard Error 3.41
Resistance Training InterventionMuscle Strength Change: Leg Press One-repetition Maximum in kgsix month follow-up15.1 kgStandard Error 2.97
Active Control GroupMuscle Strength Change: Leg Press One-repetition Maximum in kg6 weeks10.95 kgStandard Error 2.96
Active Control GroupMuscle Strength Change: Leg Press One-repetition Maximum in kg12 weeks17.93 kgStandard Error 3.74
Active Control GroupMuscle Strength Change: Leg Press One-repetition Maximum in kgsix month follow-up12.50 kgStandard Error 3.32
p-value: >0.05Mixed Models Analysis
Secondary

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.

Time frame: 6 weeks, 12 weeks, and six month follow-up

ArmMeasureGroupValue (MEAN)Dispersion
Resistance Training InterventionPhysical Functioning Change: Normal Gait Speed Time From 400-meter Walk6 weeks-14.28 secondsStandard Error 7.08
Resistance Training InterventionPhysical Functioning Change: Normal Gait Speed Time From 400-meter Walk12 weeks-18.95 secondsStandard Error 8.53
Resistance Training InterventionPhysical Functioning Change: Normal Gait Speed Time From 400-meter Walksix month follow up-14.61 secondsStandard Error 8.54
Active Control GroupPhysical Functioning Change: Normal Gait Speed Time From 400-meter Walk6 weeks-20.23 secondsStandard Error 8.07
Active Control GroupPhysical Functioning Change: Normal Gait Speed Time From 400-meter Walk12 weeks-20.89 secondsStandard Error 9.34
Active Control GroupPhysical Functioning Change: Normal Gait Speed Time From 400-meter Walksix month follow up-23.68 secondsStandard Error 9.36
p-value: >0.05Mixed Models Analysis
Secondary

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.

Time frame: 12 weeks

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Resistance Training InterventionSarcopenia Status ChangeStayed Sarcopenic7 Participants
Resistance Training InterventionSarcopenia Status ChangeStayed Non-Sarcopenic3 Participants
Resistance Training InterventionSarcopenia Status ChangeBecame Sarcopenic0 Participants
Resistance Training InterventionSarcopenia Status ChangeBecame Non-Sarcopenic2 Participants
Active Control GroupSarcopenia Status ChangeBecame Non-Sarcopenic2 Participants
Active Control GroupSarcopenia Status ChangeStayed Sarcopenic5 Participants
Active Control GroupSarcopenia Status ChangeBecame Sarcopenic0 Participants
Active Control GroupSarcopenia Status ChangeStayed Non-Sarcopenic3 Participants
p-value: 0.88Chi-squared
Other Pre-specified

Body Mass, Baseline Only.

Body mass in kg as measured from a balance-beam scale.

Time frame: baseline

ArmMeasureValue (MEAN)Dispersion
Resistance Training InterventionBody Mass, Baseline Only.68.7 kgStandard Deviation 15.5
Active Control GroupBody Mass, Baseline Only.61.8 kgStandard Deviation 10.3
Other Pre-specified

Body Mass Index Change: Weight in kg Divided by Height

Time frame: 12 weeks

Population: Missing data point at week 12.

ArmMeasureValue (MEAN)Dispersion
Resistance Training InterventionBody Mass Index Change: Weight in kg Divided by Height0.428 kg/m2Standard Deviation 0.423
Active Control GroupBody Mass Index Change: Weight in kg Divided by Height0.007 kg/m2Standard Deviation 0.472
p-value: 0.04Mixed Models Analysis
Other Pre-specified

Height

Height, measured in cm from a stadiometer

Time frame: Baseline only

ArmMeasureValue (MEAN)Dispersion
Resistance Training InterventionHeight159.8 cmStandard Deviation 5.9
Active Control GroupHeight159.7 cmStandard Deviation 5.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026