Multicomponent Exercise in the Functionality of the Elderly in the Community

October 27, 2020 updated by: José Luís Alves Sousa, Instituto Piaget
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Porto
      • Vila Nova De Gaia, Porto, Portugal, 4405-678
        • Escola Superior de Saúde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Multi component 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.
Other: Exercise Program
Exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional mobility change
Time Frame: 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.
Baseline, 8 weeks, 16 weeks
Balance change
Time Frame: 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).
Baseline, 8 weeks, 16 weeks
Cognitive status change
Time Frame: 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.
Baseline, 8 weeks, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Piaget

Investigators

  • Principal Investigator: José LA Sousa, PhD, Instituto Piaget

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (ACTUAL)

October 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InstitutoPiaget

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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