Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women
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ClinicalTrials.gov Identifier: NCT01829009 |
Recruitment Status :
Withdrawn
(Financial issues)
First Posted : April 11, 2013
Last Update Posted : April 22, 2015
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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.
Condition or disease | Intervention/treatment | Phase |
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Sarcopenia | Other: Resistance Exercise Group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women |
Actual Primary Completion Date : | April 2013 |

Arm | Intervention/treatment |
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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
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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 |
- 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 ]
- Increase in muscle mass in sarcopenic older women [ Time Frame: Increase in muscle mass in sarcopenic older women in week 24 ]

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Ages Eligible for Study: | 70 Years and older (Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829009
Mexico | |
National Institue of Medical Sciences and Nutrition Salvador Zubirán | |
Mexico City, Mexico, 14000 |
Principal Investigator: | JOSE ALBERTO AVILA FUNES, MD PhD | GERIATRICS CHIEF DEPARTMENT |
Responsible Party: | José Alberto Ávila Funes, PhD, National Institute of Medical Sciences and Nutrition, Salvador Zubiran |
ClinicalTrials.gov Identifier: | NCT01829009 |
Other Study ID Numbers: |
GER-887-13/14-1 |
First Posted: | April 11, 2013 Key Record Dates |
Last Update Posted: | April 22, 2015 |
Last Verified: | April 2015 |
Sarcopenia Elderly Women Resistance Exercise |
Sarcopenia Muscular Atrophy Neuromuscular Manifestations Neurologic Manifestations |
Nervous System Diseases Atrophy Pathological Conditions, Anatomical |