Effects of a Resistance Training Program in Older Women With Sarcopenia

Study Overview
=================
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.

Official Title
-----------------
Effects of a Resistance Training Program in Older Women With Sarcopenia

Conditions
-----------------
Sarcopenia

Intervention / Treatment
-----------------
* Behavioral: Resistance Training Intervention
* Behavioral: Active Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 84 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance Training Intervention<br>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. | Behavioral: Resistance Training Intervention<br>* 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.<br>|
| Active Comparator: Active Control Group<br>The CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching. | Behavioral: Active Control Group<br>* The CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcopenia, aging, resistance training, physical functioning