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

Study Overview
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Brief Summary
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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: Resistance Exercise Group 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
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Study withdrawn.

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

Conditions
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Sarcopenia

Intervention / Treatment
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* Other: Resistance Exercise Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: General Recommendations Group<br>General information about sarcopenia will be provided to the participants, as well as general recommendations of healthy habits. We will contact the participants weekly by phone to answer questions about sarcopenia, and remind them of their next appointment and about adverse events occured during this period of time. The frequent contact with the participants has also the purpose to prevent losses or rejections for future evaluations | |
| Experimental: Resistance Exercise Group<br>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 | Other: Resistance Exercise Group<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in muscle mass in sarcopenic older women |  | Increase in muscle mass in sarcopenic older women in week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenia, Elderly, Women, Resistance, Exercise