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

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Status: Withdrawn

Conditions: Sarcopenia

Treatments: Other: Resistance Exercise Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01829009

GER-887-13/14-1

Details and patient eligibility

About

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.

Full description

Study withdrawn.

Sex: Female

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

General Recommendations Group

No Intervention group

Description:

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

Resistance Exercise Group

Experimental group

Description:

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

Treatment:

Other: Resistance Exercise Group