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Clinical Trials/NCT03019211
NCT03019211
Completed
Not Applicable

Feasibility of a Physical Exercise Program, Performed Inside or Outside the Aquatic Environment, to Reduce Falls in Institutionalized Elderly: A Pilot Randomised Clinical Study

University Ramon Llull1 site in 1 country18 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Age Problems
Sponsor
University Ramon Llull
Enrollment
18
Locations
1
Primary Endpoint
Change from baseline Number of Falls at 3 months, 6 months and 9 months
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This is a pilot randomized control trial with single blinding of the assessor that will be conducted in two nursing homes residence to evaluate the applicability of a physical exercise program performed in an aquatic environment compared with the same realization but land-based to reduce falls in the institutionalized old people. The secondary objectives are to study the applicability of the intervention in improving balance, function, gait mobility, muscle strength of the lower limbs and the perception of the intervention.

Detailed Description

The participants will be randomized and divided into the hydrotherapy group or the control group. Each participant will attend a total of 24 physical exercise sessions of 50 minutes of duration. The study outcomes will be measured before the intervention and in 3 posterior phases to evaluate its effects in the short, medium and long terms.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
March 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Ramon Llull
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Be institutionalized in a care center
  • Participate voluntarily and sign the informed consent
  • Have a punctuation of 2 or more in The Downton Fall Risk Index

Exclusion Criteria

  • Suffer from a condition that can be affected or hinder exercise
  • Acute disease unresolved in 10 days
  • Not controlled hypertension
  • Contagious skin disorder
  • Urinary or faecal incontinence

Outcomes

Primary Outcomes

Change from baseline Number of Falls at 3 months, 6 months and 9 months

Time Frame: 3 months, 6 months, 9 months

Falls follow up

Secondary Outcomes

  • Pain measured with Visual Analogue Scale(3 months, 6 months, 9 months)
  • Muscle strength measured with Five Sit to Stand test and Handgrip Test(3 months, 6 months, 9 months)
  • Mobility measured with Timed Up & Go Test(3 months, 6 months, 9 months)
  • Balance measured with Performance Oriented Mobility Assessment(3 months, 6 months, 9 months)
  • Daily living activities measured with Barthel Test(3 months, 6 months, 9 months)
  • Intervention Perception measured with Qualitative interview(3 months)

Study Sites (1)

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