Clinical trial NCT02628145: Effects of a Resistance Training Program in Older Women With Sarcopenia
Official title: Effects of a Resistance Training Program in Older Women With Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
aging
resistance training
physical functioning
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 25
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Muscle Mass Change: From Dual Energy X-ray Absorptiometry and Bioelectrical Impedance Analsysis - Appendicular Lean Mass (ALM in kg) Divided by Height (Meters-squared)
timeFrame: 12 weeks
Secondary outcomes:
measure: Sarcopenia Status Change
timeFrame: 12 weeks
measure: Balance Ability: Single-leg Stand. Scored Yes or No
timeFrame: 12 weeks
measure: Mobility Change: 8 Foot Timed up and go From a Seated Position Around a Cone Back to a Seated Position
timeFrame: 12 weeks
measure: Hip Bone Mineral Density: Measured by Dual Energy X-ray Absorptiometry
timeFrame: 12 weeks
measure: Physical Functioning Change: Normal Gait Speed Time From 400-meter Walk
timeFrame: 6 weeks, 12 weeks, and six month follow-up
measure: Grip Strength Change: From Hand Grip Dynamometry in kg
timeFrame: 6 weeks, 12 weeks, and six month follow-up
measure: Muscle Strength Change: Leg Press One-repetition Maximum in kg
timeFrame: 6 weeks, 12 weeks, and six month follow-up
measure: Chair Stand Time Change: Time to Complete Five Chair Rises From a Normal Chair
timeFrame: 6 weeks, 12 weeks, and six month follow-up
measure: Chair Stand Ability: Ability to Rise From a Chair One Time - Yes or No
timeFrame: Baseline
Other outcomes:
measure: Body Mass Index Change: Weight in kg Divided by Height
timeFrame: 12 weeks
measure: Body Mass, Baseline Only.
timeFrame: baseline
measure: Height
timeFrame: Baseline only
Locations:
city: Kingston
country: United States
facility: University of Rhode Island
state: Rhode Island
Study officials:
affiliation: University of Rhode Island
name: Mattthew J Delmonico, PhD
role: PRINCIPAL_INVESTIGATOR
References: