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Clinical Trials/NCT01829009
NCT01829009
Withdrawn
N/A

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

National Institute of Medical Sciences and Nutrition, Salvador Zubiran1 site in 1 countryApril 11, 2013
ConditionsSarcopenia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Locations
1
Primary Endpoint
Improvement in gait speed and functional status in sarcopenic older women
Status
Withdrawn
Last Updated
11 years ago

Overview

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Study withdrawn.

Registry
clinicaltrials.gov
Start Date
April 11, 2013
End Date
April 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Responsible Party
Principal Investigator
Principal Investigator

José Alberto Ávila Funes

PhD

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Improvement in gait speed and functional status in sarcopenic older women

Time Frame: improvement in gait speed and functional status in sarcopenic older women in weeks 6,12 and 24

Secondary Outcomes

  • Increase in muscle mass in sarcopenic older women(Increase in muscle mass in sarcopenic older women in week 24)

Study Sites (1)

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