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

Primary Purpose

Sarcopenia

Status
Withdrawn
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Resistance Exercise Group
Sponsored by
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Sarcopenia, Elderly, Women, Resistance, Exercise

Eligibility Criteria

70 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • National Institue of Medical Sciences and Nutrition Salvador Zubirán

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

General Recommendations Group

Resistance Exercise Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement in gait speed and functional status in sarcopenic older women

Secondary Outcome Measures

Increase in muscle mass in sarcopenic older women

Full Information

First Posted
April 2, 2013
Last Updated
April 20, 2015
Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT01829009
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Financial issues
Study Start Date
undefined (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.
Detailed Description
Study withdrawn.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, Elderly, Women, Resistance, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General Recommendations Group
Arm Type
No Intervention
Arm Description
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
Arm Title
Resistance Exercise Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Resistance Exercise Group
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Increase in muscle mass in sarcopenic older women
Time Frame
Increase in muscle mass in sarcopenic older women in week 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOSE ALBERTO AVILA FUNES, MD PhD
Organizational Affiliation
GERIATRICS CHIEF DEPARTMENT
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institue of Medical Sciences and Nutrition Salvador Zubirán
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
9164280
Citation
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Resistance Exercise Effect on Physical Performance and Functional Status in Sarcopenic Older Women

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