Feasibility Aquatic Physical Exercise to Reduce Falls in Institutionalized Elderly (PrePhysFalls)

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Elderly; Postural Balance; Strength; Age Problems
• Intervention / Treatment: Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Universitat Ramon Llull

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrotherapy; Exercise performed in an aquatic environment. The participants will perform static/dynamic exercises (balance and resistance training) in an aquatic environment. Training volume and intensity we will increase systematically over 12 weeks.	Other: Exercise
Active Comparator: Control; The participants will perform exercises (balance and resistance training) like hydrotherapy group but out of the aquatic environment, during a 12 weeks training period (3sessions/week). Training volume and intensity we will increase systematically over 12 weeks.	Other: Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Number of Falls at 3 months, 6 months and 9 months	Falls follow up	3 months, 6 months, 9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Ramon Llull
• Collaborators: Sanitas Mayores Les Corts; Residencial Augusta Park
• Investigators: Principal Investigator: Mercè Sitjà Rabert, PhD, PT, University Ramon Llull

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: January 8, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Elderly; Physical Therapy Modalities; Nursing Home; Hydrotherapy; Accidental Fall
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: PrePhysFalls

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO