Multicomponent Exercise in the Functionality of the Elderly in the Community

Not Applicable

Completed

• Conditions: Cognition; Aging; Balance; Mobility Limitation
• Interventions: Other: Exercise Program

• Registration Number: NCT04606667
• Lead Sponsor: Instituto Piaget

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.

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2011-06
• Study Completion: 2011-09
• Study First Submitted: 2020-09-18
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Study First Posted: 2020-10-28
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multi component program	Exercise Program	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.

Primary Outcome Measures

Name	Time	Method
Functional mobility change	Baseline, 8 weeks, 16 weeks	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	Baseline, 8 weeks, 16 weeks	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	Baseline, 8 weeks, 16 weeks	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.

Trial Locations

Locations (1)

Escola Superior de Saúde; 🇵🇹 Vila Nova De Gaia, Porto, Portugal