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

Primary Purpose

Age Problems, Cognitive Impairment, Elderly

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise
Sponsored by
University Ramon Llull
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Problems focused on measuring Physical Therapy Modalities, Accidental Fall, Elderly, Hydrotherapy, Nursing Home

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitat Ramon Llull

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydrotherapy

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Balance measured with Performance Oriented Mobility Assessment
Measured with Performance Oriented Mobility Assessment
Pain measured with Visual Analogue Scale
Measured with Visual Analogue Scale
Mobility measured with Timed Up & Go Test
Measured with Timed Up & Go Test
Daily living activities measured with Barthel Test
Measured with Barthel Test
Muscle strength measured with Five Sit to Stand test and Handgrip Test
Measured with Five Sit to Stand test and Handgrip Test
Intervention Perception measured with Qualitative interview
Qualitative interview

Full Information

First Posted
January 8, 2017
Last Updated
May 2, 2017
Sponsor
University Ramon Llull
Collaborators
Sanitas Mayores Les Corts, Residencial Augusta Park
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1. Study Identification

Unique Protocol Identification Number
NCT03019211
Brief Title
Feasibility Aquatic Physical Exercise to Reduce Falls in Institutionalized Elderly
Acronym
PrePhysFalls
Official Title
Feasibility of a Physical Exercise Program, Performed Inside or Outside the Aquatic Environment, to Reduce Falls in Institutionalized Elderly: A Pilot Randomised Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ramon Llull
Collaborators
Sanitas Mayores Les Corts, Residencial Augusta Park

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Problems, Cognitive Impairment, Elderly, Postural Balance, Strength
Keywords
Physical Therapy Modalities, Accidental Fall, Elderly, Hydrotherapy, Nursing Home

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Primary Outcome Measure Information:
Title
Change from baseline Number of Falls at 3 months, 6 months and 9 months
Description
Falls follow up
Time Frame
3 months, 6 months, 9 months
Secondary Outcome Measure Information:
Title
Balance measured with Performance Oriented Mobility Assessment
Description
Measured with Performance Oriented Mobility Assessment
Time Frame
3 months, 6 months, 9 months
Title
Pain measured with Visual Analogue Scale
Description
Measured with Visual Analogue Scale
Time Frame
3 months, 6 months, 9 months
Title
Mobility measured with Timed Up & Go Test
Description
Measured with Timed Up & Go Test
Time Frame
3 months, 6 months, 9 months
Title
Daily living activities measured with Barthel Test
Description
Measured with Barthel Test
Time Frame
3 months, 6 months, 9 months
Title
Muscle strength measured with Five Sit to Stand test and Handgrip Test
Description
Measured with Five Sit to Stand test and Handgrip Test
Time Frame
3 months, 6 months, 9 months
Title
Intervention Perception measured with Qualitative interview
Description
Qualitative interview
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercè Sitjà Rabert, PhD, PT
Organizational Affiliation
University Ramon Llull
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Ramon Llull
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility Aquatic Physical Exercise to Reduce Falls in Institutionalized Elderly

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