Effects of a Resistance Training Program in Older Women With Sarcopenia

NCT02628145 | Completed Results

• 1 other identifier: HU1415-168
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; aging; resistance training; physical functioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Sarcopenia Status Change

  12 weeks

• Balance Ability: Single-leg Stand. Scored Yes or No

  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

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

Other Outcomes (3)

• Body Mass Index Change: Weight in kg Divided by Height

  12 weeks

• Body Mass, Baseline Only.

  baseline

• Height

  Baseline only

Study Arms (2)

Resistance Training Intervention

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.

Behavioral: Resistance Training Intervention

Active Control Group

ACTIVE COMPARATOR

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

Behavioral: Active Control Group

Interventions

Resistance Training Intervention BEHAVIORAL

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.

Resistance Training Intervention

Active Control Group BEHAVIORAL

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

Active Control Group

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rhode Island: lead

Study Sites (1)

University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Matthew Delmonico
• Organization: University of Rhode Island

delmonico@uri.edu

4018745440

Study Officials

• Mattthew J Delmonico, PhD

  University of Rhode Island

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 11, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 4, 2023
• Results First Posted: October 4, 2023

Record last verified: 2022-12

Locations

US (1)