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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Active Control Group | Active Comparator | The CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance Training Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index Change: Weight in kg Divided by Height | 12 weeks | |
| Body Mass, Baseline Only. | Body mass in kg as measured from a balance-beam scale. | baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mattthew J Delmonico, PhD | University of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rhode Island | Kingston | Rhode Island | 02881 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Error | kg/m2 | 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Delmonico | University of Rhode Island | 4018745440 | delmonico@uri.edu |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| Active Control Group | Behavioral | The CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching. |
|
| 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. | 12 weeks |
| Mobility Change: 8 Foot Timed up and go From a Seated Position Around a Cone Back to a Seated Position | 12 weeks |
| Hip Bone Mineral Density: Measured by Dual Energy X-ray Absorptiometry | 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. | 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. | 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. | 6 weeks, 12 weeks, and six month follow-up |
| Chair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair | 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 | Baseline |
| Height | Height, measured in cm from a stadiometer | Baseline only |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 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. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 12 weeks |
|
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| Secondary | Mobility Change: 8 Foot Timed up and go From a Seated Position Around a Cone Back to a Seated Position | Posted | Mean | Standard Error | seconds | 12 weeks |
|
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|
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| Secondary | Hip Bone Mineral Density: Measured by Dual Energy X-ray Absorptiometry | Posted | Mean | Standard Deviation | g/m2 | 12 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Error | seconds | 6 weeks, 12 weeks, and six month follow-up |
|
|
|
|
| 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. | Posted | Mean | Standard Error | kg | 6 weeks, 12 weeks, and six month follow-up |
|
|
|
|
| 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. | Two participants from each group chose not to be retested. | Posted | Mean | Standard Error | kg | 6 weeks, 12 weeks, and six month follow-up |
|
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| Secondary | Chair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair | Missing data or participants chose not to be retested. | Posted | Mean | Standard Error | seconds | 6 weeks, 12 weeks, and six month follow-up |
|
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|
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| 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 | Posted | Count of Participants | Participants | Baseline |
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| Other Pre-specified | Body Mass Index Change: Weight in kg Divided by Height | Missing data point at week 12. | Posted | Mean | Standard Deviation | kg/m2 | 12 weeks |
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| Other Pre-specified | Body Mass, Baseline Only. | Body mass in kg as measured from a balance-beam scale. | Posted | Mean | Standard Deviation | kg | baseline |
|
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| Other Pre-specified | Height | Height, measured in cm from a stadiometer | Posted | Mean | Standard Deviation | cm | Baseline only |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| Became Sarcopenic |
|
| Became Non-Sarcopenic |
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| Developed Single Leg Stand Ability |
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| Lost Single Leg Stand Ability. |
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| six month follow up |
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| six month follow up |
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| 12 weeks |
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| six month follow-up |
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| 12 weeks |
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| six month follow-up |
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