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

April 20, 2015 updated by: José Alberto Ávila Funes, National Institute of Medical Sciences and Nutrition, Salvador Zubiran

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Study withdrawn.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14000
        • National Institue of Medical Sciences and Nutrition Salvador Zubirán

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: General Recommendations Group
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

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

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Increase in muscle mass in sarcopenic older women
Time Frame: Increase in muscle mass in sarcopenic older women in week 24
Increase in muscle mass in sarcopenic older women in week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Investigators

  • Principal Investigator: JOSE ALBERTO AVILA FUNES, MD PhD, GERIATRICS CHIEF DEPARTMENT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GER-887-13/14-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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