Clinical trial NCT01829009: Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women
Official title: Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
Elderly
Women
Resistance
Exercise
Lead sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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Detailed description: Study withdrawn.

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)
* Orthostatic hypotension

Primary outcomes:
measure: Improvement in gait speed and functional status in sarcopenic older women
timeFrame: improvement in gait speed and functional status in sarcopenic older women in weeks 6,12 and 24
Secondary outcomes:
measure: Increase in muscle mass in sarcopenic older women
timeFrame: Increase in muscle mass in sarcopenic older women in week 24
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institue of Medical Sciences and Nutrition Salvador Zubirán
Study officials:
affiliation: GERIATRICS CHIEF DEPARTMENT
name: JOSE ALBERTO AVILA FUNES, MD PhD
role: PRINCIPAL_INVESTIGATOR
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