EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM IN INSTITUTIONALIZED ELDERLY

July 18, 2023 updated by: JOSE VICENTE TOLEDO MARHUENDA, Universidad Miguel Hernandez de Elche

EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM ON PREDICTORS OF RISK OF FALLS IN INSTITUTIONALIZED ELDERLY

Knowing the effects of proprioceptive exercise program in improving balance, gait and risk of falls in institutionalized elderly.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study will be to determine the effects of proprioceptive exercise program in improving balance and gait as well as reducing the risk of falls in institutionalized elderly in a healthcare center. To evaluate this effect, a total of 45 subjects will participate in a longitudinal and controlled trial. Inclusion criteria will be over 65 years olds, be institutionalized in the center and have ability to read and write.

Thereafter, participants will be separated into two different groups (experimental and control). Randomization was performed using sealed envelopes with different numbers of intervention inside. Both groups will be evaluated both at the start of the first session and in the last working session.

The control group performed a geriatric revitalization program as the experimental group. Besides this one, experimental group performed a program of proprioceptive exercises. The intervention rate will 2 weekly sessions for 12 weeks for both groups (24 sessions), lasting 55 minutes. The variables analyzed were: the questionnaire risk of falls in hospital (MORSE), Tinetti scale, the test Timed Up and Go (TUG), the time of one leg and the Cooper test running 12 minutes.

The data analysis will perform using the Statistical Package for the Social Sciences (SPSS statistical software), version 19.0 for Windows, Chicago.

To determine the normal distribution of the data the Shapiro-Wilks test and comparison by ANOVA was performed. The values obtained in the pretest and posttest assessment for each variable will be compared by Student t test for related samples or by the Wilcoxon rank test.

Study Type

Interventional

Enrollment (Actual)

50

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

  • Spain
    • Extremadura
      • Badajoz, Extremadura, Spain, 06006
        • Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz

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

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being institutionalized,
  • own ability to read and write,
  • and access the study voluntarily.

Exclusion Criteria:

  • Significant degree of cognitive impairment;
  • intolerance moderate physical activity, caused by cardiovascular or respiratory disease,
  • as well as those who did not complete 90% of the sessions.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cotrol
No propioceptive program.
Other: No propioceptive program
The control group continued to perform their daily activities without changing any habit. Geriatric revitalization program without proprioceptive exercises.
Experimental: Experimental
Propioceptive program
Other: propioceptive program
The training program has 6 specific proprioceptive exercises, each five minutes long, which will conducted in static and dynamic positions for a period of 30 minutes. Each exercise session will include 55 minutes (15 minutes of warm-up with slow walk, mobility and stretching exercise, followed by 30 minutes of a propioceptive exercises program, and finishing with 10 minutes of cool down through stretching and relaxation exercises)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time Up and Go (TUG) test
Time Frame: Participants will be followed an expected average of 5 weeks.
Evaluates mobility testing both static balance and the dynamic by measuring the time taken to perform a task.
Participants will be followed an expected average of 5 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnetti scale
Time Frame: Participants will be followed an expected average of 5 weeks.
It consists of two subscales, gait and balance, where less than 19 points overall results indicate a high risk of falling
Participants will be followed an expected average of 5 weeks.
Questionnaire risk of falls in hospital (Morse)
Time Frame: Participants will be followed an expected average of 5 weeks.
This questionnaire has 6 items with a total range of 0-125.
Participants will be followed an expected average of 5 weeks.
Cooper test
Time Frame: Participants will be followed an expected average of 5 weeks.
Walking for 12 minutes around cones along the floor.
Participants will be followed an expected average of 5 weeks.
Support time monopodal
Time Frame: Participants will be followed an expected average of 5 weeks.
Postural control is valued.
Participants will be followed an expected average of 5 weeks.

Collaborators and Investigators

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

Sponsor

Universidad Miguel Hernandez de Elche

Collaborators

Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz

Investigators

  • Principal Investigator: María Ángeles Cardero-Durán, PhD, University of Extremadura

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

July 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 31, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimated)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JVT001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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