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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor:
Information provided by (Responsible Party):
José Alberto Ávila Funes, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier:
NCT01829009
First received: April 2, 2013
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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.

Condition Intervention
Sarcopenia
Other: Resistance Exercise Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women

Resource links provided by NLM:


Further study details as provided by National Institute of Medical Sciences and Nutrition, Salvador Zubiran:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase in muscle mass in sarcopenic older women [ Time Frame: Increase in muscle mass in sarcopenic older women in week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  • Orthostatic hypotension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01829009

Locations
Mexico
National Institue of Medical Sciences and Nutrition Salvador Zubirán Not yet recruiting
Mexico City, Mexico, 14000
Contact: JOSE ALBERTO MD AVILA, MD,PhD    525554870900 ext 5701    avilafunes@live.com.mx   
Contact: MAURICIO MORENO, MD    525554870900 ext 5701    piga79@gmail.com   
Principal Investigator: JOSÉ ALBERTO MD ÁVILA-FUNES, PhD         
Sponsors and Collaborators
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Investigators
Principal Investigator: JOSE ALBERTO AVILA FUNES, MD PhD GERIATRICS CHIEF DEPARTMENT
  More Information

Publications:
Kim HK, Suzuki T, Saito K, et al. Effects of Exercise and Amino Acid Supplementation on Body Composition and Physical Function in Community-Dwelling Elderly Japanese Sarcopenic Women: A Randomized Controlled Trial. J Am Geriatr Soc 2012;60:16-23

Responsible Party: José Alberto Ávila Funes, PhD, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01829009     History of Changes
Other Study ID Numbers: GER-887-13/14-1
Study First Received: April 2, 2013
Last Updated: April 8, 2013
Health Authority: Mexico: Ethics Committee

Keywords provided by National Institute of Medical Sciences and Nutrition, Salvador Zubiran:
Sarcopenia
Elderly
Women
Resistance
Exercise

Additional relevant MeSH terms:
Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014