Back to resultsMulticomponent Exercise in the Functionality of the Elderly in the Community
Primary Purpose
Aging, Cognition, Balance
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Exercise Program
Sponsored by
About this trial
This is an interventional prevention trial for Aging focused on measuring Aging, Community, Exercise program, Physiotherapy, Functionality
Eligibility Criteria
Inclusion Criteria:
- be supported by day centers or collective residences linked to the "Project + City",
- not having regular exercise habits,
- ability to walk (with or without assistance).
Exclusion Criteria:
- not being collaborative,
- missing the classes three times.
Sites / Locations
- Escola Superior de Saúde
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multi component program
Arm Description
The intervention lasted 16 weeks, with the evaluations carried out at baseline, after 8 weeks and at the end. The multi-component exercise program took place in day centers or collective residences. It was supervised by physiotherapists. The classes took place 3 times a week, at the same hour and on alternate days, for 45-60 minutes, for a total of 48 sessions. The program consisted on a warm-up (5 min) with exercises and walking, a balance and strength training (35-40 min) with exercises repeated 3 times and held for 15 seconds flexibility / relaxation (5 to 10 mins) periods. The strength training is performed with the resistance of the body weight or accessible and low cost equipment, with two series of 10 to 15 repetitions, after maximum resistance was calculated. The flexibility and cooling training consists of 3 repetitions maintained for 15 seconds.
Outcomes
Primary Outcome Measures
Functional mobility change
Timed Up and Go Test is a validated test that consists on a timed 3 meter defined circuit after getting up from a chair and sitting in it. The categories of achievement are three: less than 10 seconds "without compromise", corresponding to normal performance; between 10.01 and 20 seconds it is considered "slight impairment or normal time for frail elderly"; more than 20.01 seconds corresponds to a degree of "functional impairment" that requires a more detailed assessment.
Balance change
Berg scale is a validated instrument to assess balance and the risk of falling associated with its loss. From 56 to 54 points, each point less is associated with a 3 to 4% increase in the risk of falling, from 54 to 46 a change in one point is associated with a 6 to 8% increase in the risk of falling, and below 36 points the risk of falling is very close to 100%, which allows the results to be divided into 4 balance categories: "Total balance problem" (≤36 points); "Serious balance problem" (37-45 points); "Moderate balance problem" (46-53 points) and "normal balance" (≥54 points).
Cognitive status change
Mini mental exam scale is a validate instrument to assess the cognitive function and the detection of potential dementia. Individuals are classified into three categories: a score equal to or less than 18 points corresponds to "severe cognitive impairment"; from 19 to 23 points "moderate cognitive impairment" and 24 or more points "normal cognitive state. The literature states that for the diagnosis of dementia, the scale results must be cross-checked with schooling, however when the objective is not to diagnose dementia, but only to characterize and assess changes in cognitive status, the crossing of the scale results with schooling does not justified.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04606667
Brief Title
Multicomponent Exercise in the Functionality of the Elderly in the Community
Official Title
Multicomponent Exercise in the Functionality of the Elderly in the Community
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 2009 (Actual)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Piaget
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluate the results of the implementation of a multicomponent exercise program (16 weeks) for elder community dwelling population on their functionality (via cognitive, balance and mobility status).
Detailed Description
A quasi-experimental study, of the pre-test-post-test type, with a sample for convenience from in a cohort of elderly community dwelling people, carried out between 2009 and 2011. The general objective is to verify the impact of a physical exercise program organized in classes, under the supervision of physiotherapists.The specific objectives are to analyze the effect after 8 and 16 weeks, on the functionality of the elderly person, discriminating three conditions: cognitive state, balance and functional mobility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Cognition, Balance, Mobility Limitation
Keywords
Aging, Community, Exercise program, Physiotherapy, Functionality
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi-experimental, test-retest, with one sample.
Masking
None (Open Label)
Allocation
N/A
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multi component program
Arm Type
Experimental
Arm Description
The intervention lasted 16 weeks, with the evaluations carried out at baseline, after 8 weeks and at the end.
The multi-component exercise program took place in day centers or collective residences. It was supervised by physiotherapists. The classes took place 3 times a week, at the same hour and on alternate days, for 45-60 minutes, for a total of 48 sessions. The program consisted on a warm-up (5 min) with exercises and walking, a balance and strength training (35-40 min) with exercises repeated 3 times and held for 15 seconds flexibility / relaxation (5 to 10 mins) periods. The strength training is performed with the resistance of the body weight or accessible and low cost equipment, with two series of 10 to 15 repetitions, after maximum resistance was calculated.
The flexibility and cooling training consists of 3 repetitions maintained for 15 seconds.
Intervention Type
Other
Intervention Name(s)
Exercise Program
Intervention Description
Exercise program
Primary Outcome Measure Information:
Title
Functional mobility change
Description
Timed Up and Go Test is a validated test that consists on a timed 3 meter defined circuit after getting up from a chair and sitting in it. The categories of achievement are three: less than 10 seconds "without compromise", corresponding to normal performance; between 10.01 and 20 seconds it is considered "slight impairment or normal time for frail elderly"; more than 20.01 seconds corresponds to a degree of "functional impairment" that requires a more detailed assessment.
Time Frame
Baseline, 8 weeks, 16 weeks
Title
Balance change
Description
Berg scale is a validated instrument to assess balance and the risk of falling associated with its loss. From 56 to 54 points, each point less is associated with a 3 to 4% increase in the risk of falling, from 54 to 46 a change in one point is associated with a 6 to 8% increase in the risk of falling, and below 36 points the risk of falling is very close to 100%, which allows the results to be divided into 4 balance categories: "Total balance problem" (≤36 points); "Serious balance problem" (37-45 points); "Moderate balance problem" (46-53 points) and "normal balance" (≥54 points).
Time Frame
Baseline, 8 weeks, 16 weeks
Title
Cognitive status change
Description
Mini mental exam scale is a validate instrument to assess the cognitive function and the detection of potential dementia. Individuals are classified into three categories: a score equal to or less than 18 points corresponds to "severe cognitive impairment"; from 19 to 23 points "moderate cognitive impairment" and 24 or more points "normal cognitive state. The literature states that for the diagnosis of dementia, the scale results must be cross-checked with schooling, however when the objective is not to diagnose dementia, but only to characterize and assess changes in cognitive status, the crossing of the scale results with schooling does not justified.
Time Frame
Baseline, 8 weeks, 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
be supported by day centers or collective residences linked to the "Project + City",
not having regular exercise habits,
ability to walk (with or without assistance).
Exclusion Criteria:
not being collaborative,
missing the classes three times.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José LA Sousa, PhD
Organizational Affiliation
Instituto Piaget
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escola Superior de Saúde
City
Vila Nova De Gaia
State/Province
Porto
ZIP/Postal Code
4405-678
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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19516148
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Multicomponent Exercise in the Functionality of the Elderly in the Community
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