Effects of a Resistance Training Program in Older Women With Sarcopenia (RESTORE-ME)

University of Rhode Island

Status: Completed

Conditions: Sarcopenia

Treatments: Behavioral: Active Control Group; Behavioral: Resistance Training Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02628145

HU1415-168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 65 to 84 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Resistance Training Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Resistance Training Intervention

Active Control Group

Active Comparator group

Description:

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

Treatment:

Behavioral: Active Control Group