Overview

This trial has been completed.

Condition sarcopenia
Treatments resistance training intervention, active control group
Sponsor University of Rhode Island
Start date August 2015
End date June 2016
Trial size 25 participants
Trial identifier NCT02628145, HU1415-168

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(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.
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 Comparator)
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.

Primary Outcomes

Measure
Muscle Mass Change: From dual energy x-ray absorptiometry and bioelectrical impedance analsysis - 1) appendicular lean mass (kg) divided by height (meters-squared) and 2) appendicular lean mass divided by body mass index
time frame: 12 weeks and six month follow up

Secondary Outcomes

Measure
Physical Functioning Change: normal gait speed time from 4-meter walk and 400-meter walk
time frame: 6 weeks, 12 weeks, and six month follow up
Grip strength change: From hand grip dynamometry in kg
time frame: 6 weeks, 12 weeks and six month follow up
Sarcopenia Status Change: Established European Working Group and NIH Sarcopenia Project guidelines for 1) appendicular lean mass (aLM) divided by height (meters-sq) or aLM divided by BMI, 2) muscle strength (grip or chair stand); 3) gait speed (m/sec)
time frame: 12 weeks and six month follow up
Muscle strength change: Chest press and leg press one-repetition maximum in kg
time frame: 12 weeks and six month follow up
Chair stand time change: time to complete five chair rises from a normal chair
time frame: 6 weeks, 12 weeks and six month follow up
Chair stand ability: ability to rise from a chair one time - Yes or No
time frame: 6 weeks, 12 weeks and six month follow up
Mobility change: 8 foot timed up and go from a seated position around a cone back to a seated position
time frame: 6 weeks, 12 weeks and six month follow up
Balance ability change: standing balance tests with 1) feet side to side, 2) semi-tandem, 3) full tandem, and 4) single leg. Scored as Yes or No.
time frame: 6 weeks, 12 weeks and six month follow up
Hip bone mineral density: measured by dual energy x-ray absorptiometry
time frame: 6 weeks, 12 weeks and six month follow up

Eligibility Criteria

Female participants from 65 years up to 84 years old.

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.

Additional Information

Official title Effects of a Resistance Training Program in Older Women With Sarcopenia
Principal investigator Mattthew J Delmonico, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Rhode Island.