Trial Outcomes & Findings for Effects of a Resistance Training Program in Older Women With Sarcopenia (NCT NCT02628145)

NCT ID: NCT02628145

Last Updated: 2023-10-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2023-10-04

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	13	12
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of a Resistance Training Program in Older Women With Sarcopenia

Baseline characteristics by cohort

Measure	Resistance Training Intervention n=13 Participants 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.	Active Control Group n=12 Participants 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.	Total n=25 Participants Total of all reporting groups
Age, Continuous	71.8 years STANDARD_DEVIATION 4.8 • n=5 Participants	72.9 years STANDARD_DEVIATION 4.6 • n=7 Participants	72.3 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Muscle 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/m2 Standard Error 0.08	0.10 kg/m2 Standard Error 0.09

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Sarcopenia Status Change Stayed Sarcopenic	7 Participants	5 Participants
Sarcopenia Status Change Stayed Non-Sarcopenic	3 Participants	3 Participants
Sarcopenia Status Change Became Sarcopenic	0 Participants	0 Participants
Sarcopenia Status Change Became Non-Sarcopenic	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 weeks

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.

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Balance Ability: Single-leg Stand. Scored Yes or No Maintained Single Leg Stand Ability	5 Participants	4 Participants
Balance Ability: Single-leg Stand. Scored Yes or No Maintained Single Leg Stand Inability	3 Participants	4 Participants
Balance Ability: Single-leg Stand. Scored Yes or No Developed Single Leg Stand Ability	3 Participants	2 Participants
Balance Ability: Single-leg Stand. Scored Yes or No Lost Single Leg Stand Ability.	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Mobility Change: 8 Foot Timed up and go From a Seated Position Around a Cone Back to a Seated Position	-0.48 seconds Standard Error 0.25	-0.74 seconds Standard Error 0.27

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Hip Bone Mineral Density: Measured by Dual Energy X-ray Absorptiometry	-0.0005 g/m2 Standard Deviation 0.0197	0.0105 g/m2 Standard Deviation 0.0548

SECONDARY outcome

Timeframe: 6 weeks, 12 weeks, and six month follow-up

Change in timed 400-meter walk in seconds doing laps in a measured corridor at a pace that the participant can maintain.

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Physical Functioning Change: Normal Gait Speed Time From 400-meter Walk 6 weeks	-14.28 seconds Standard Error 7.08	-20.23 seconds Standard Error 8.07
Physical Functioning Change: Normal Gait Speed Time From 400-meter Walk 12 weeks	-18.95 seconds Standard Error 8.53	-20.89 seconds Standard Error 9.34
Physical Functioning Change: Normal Gait Speed Time From 400-meter Walk six month follow up	-14.61 seconds Standard Error 8.54	-23.68 seconds Standard Error 9.36

SECONDARY outcome

Timeframe: 6 weeks, 12 weeks, and six month follow-up

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.

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Grip Strength Change: From Hand Grip Dynamometry in kg 12 weeks	1.67 kg Standard Error 1.03	0.50 kg Standard Error 1.26
Grip Strength Change: From Hand Grip Dynamometry in kg 6 weeks	1.08 kg Standard Error 0.90	1.45 kg Standard Error 1.03
Grip Strength Change: From Hand Grip Dynamometry in kg six month follow up	0.25 kg Standard Error 0.95	-0.10 kg Standard Error 1.04

SECONDARY outcome

Timeframe: 6 weeks, 12 weeks, and six month follow-up

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

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.

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Muscle Strength Change: Leg Press One-repetition Maximum in kg 6 weeks	13.35 kg Standard Error 2.71	10.95 kg Standard Error 2.96
Muscle Strength Change: Leg Press One-repetition Maximum in kg 12 weeks	20.85 kg Standard Error 3.41	17.93 kg Standard Error 3.74
Muscle Strength Change: Leg Press One-repetition Maximum in kg six month follow-up	15.1 kg Standard Error 2.97	12.50 kg Standard Error 3.32

SECONDARY outcome

Timeframe: 6 weeks, 12 weeks, and six month follow-up

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

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Chair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair 6 weeks	-0.95 seconds Standard Error 0.78	-1.05 seconds Standard Error 0.90
Chair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair 12 weeks	-1.56 seconds Standard Error 1.05	-2.39 seconds Standard Error 1.10
Chair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair six month follow-up	-1.13 seconds Standard Error 0.88	-2.70 seconds Standard Error 1.00

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Chair Stand Ability: Ability to Rise From a Chair One Time - Yes or No Able to Rise from a Chair	12 Participants	10 Participants
Chair Stand Ability: Ability to Rise From a Chair One Time - Yes or No Unable to Rise from a Chair	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Missing data point at week 12.

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Body Mass Index Change: Weight in kg Divided by Height	0.428 kg/m2 Standard Deviation 0.423	0.007 kg/m2 Standard Deviation 0.472

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline

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

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Body Mass, Baseline Only.	68.7 kg Standard Deviation 15.5	61.8 kg Standard Deviation 10.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline only

Height, measured in cm from a stadiometer

Outcome measures

Measure	Resistance Training Intervention n=12 Participants 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 following 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 an 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 the training phase. E.g., the first portion of the 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 a few unilateral and multi-joint light free weight exercises. 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 Group n=10 Participants 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.
Height	159.8 cm Standard Deviation 5.9	159.7 cm Standard Deviation 5.2

Adverse Events

Resistance Training Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthew Delmonico

University of Rhode Island

Phone: 4018745440

Email: delmonico@uri.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place