Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women

Not Applicable

Withdrawn

• Conditions: Sarcopenia
• Interventions: Other: Resistance Exercise Group

• Registration Number: NCT01829009
• Lead Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Brief Summary

Aging is characterized by a progressive loss of multiple physical and cognitive abilities. From these changes, the most important one is the loss of muscle mass, which has been called "sarcopenia". Resistance exercise is a therapeutic approach for sarcopenia, nevertheless there is no universal consensus. Therefore, this research is interested in determining the effect of a resistance exercise program on physical performance and/or functional status in sarcopenic older women. The main study hypothesis is that a program of resistance exercise will improve physical performance and functional status in sarcopenic older women compared against general recommendations.

This is a single-blind, controlled clinical trial, including women\> 70 years, living in the community with sarcopenia. Those who agree to participate, will be randomly assigned to one of the following groups:

1. Resistance Exercise Group

2. General Recommendations Group (control) The study will last 24 weeks, with 4 measurements performed at baseline, week 6, 12 and 24. Multilevel models (random effects) will be constructed for the comparison between the two groups. Tests will be conducted with a P=0.05 and confidence intervals at 95%. This protocol has been approved by the local ethics committee.

Detailed Description

Study withdrawn.

Study Timeline

• Primary Completion: 2013-04
• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Body mass composition by BIA with skeletal muscle mass <6.76kg/m2
• Speed gait of <0.8m/sec
• Handgrip strength (adjusted for BMI) less than 20kg

Exclusion Criteria

• Current diagnosis of malnutrition (BMI <19kg/m2)
• Decompensated heart failure (NYHA III or IV)
• Hemiplegia or hemiparesis due to cerebral vascular disease
• Exacerbation of chronic obstructive pulmonary disease
• Dementia (any type, moderate or severe stage)
• Uncontrolled diabetes mellitus (glycosylated hemoglobin >8%)
• Severe pain in hips, knees or ankles
• Fracture of lower limb in the last 6 months
• Myocardial infarction within the past 6 months
• Severe hypertension (SBP > 180mmHg or DBP > 110 mmHg)
• Orthostatic hypotension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistance Exercise Group	Resistance Exercise Group	An individualized resistance exercise program wil be applied twice a week by an expert physiotherapist. Every 2 weeks, intensity will be reassessed by the same physiotherapist. Weekly, participants will be asked about incidents such as the occurrence of falls or hospitalizations during this study period. Physical performance and functional status will be assessed by the blind investigator at weeks 6,12 and 24

Primary Outcome Measures

Name	Time	Method
Improvement in gait speed and functional status in sarcopenic older women	improvement in gait speed and functional status in sarcopenic older women in weeks 6,12 and 24

Secondary Outcome Measures

Name	Time	Method
Increase in muscle mass in sarcopenic older women	Increase in muscle mass in sarcopenic older women in week 24

Trial Locations

Locations (1)

National Institue of Medical Sciences and Nutrition Salvador Zubirán; 🇲🇽 Mexico City, Mexico