Feasibility Aquatic Physical Exercise to Reduce Falls in Institutionalized Elderly

Cognitive Impairment Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019211
• Other study ID #: PrePhysFalls
• Status: Completed
• Phase: N/A
• First received: January 8, 2017
• Last updated: May 2, 2017
• Start date: April 2016
• Est. completion date: March 2017

Study information

• Verified date: September 2016
• Source: University Ramon Llull
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Problems
• Cognition Disorders
• Cognitive Impairment
• Elderly
• Postural Balance
• Strength

Intervention

Other:
• Exercise

Locations

Country	Name	City	State
Spain	Universitat Ramon Llull	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
University Ramon Llull	Residencial Augusta Park, Sanitas Mayores Les Corts

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Number of Falls at 3 months, 6 months and 9 months	Falls follow up	3 months, 6 months, 9 months
Secondary	Balance measured with Performance Oriented Mobility Assessment	Measured with Performance Oriented Mobility Assessment	3 months, 6 months, 9 months
Secondary	Pain measured with Visual Analogue Scale	Measured with Visual Analogue Scale	3 months, 6 months, 9 months
Secondary	Mobility measured with Timed Up & Go Test	Measured with Timed Up & Go Test	3 months, 6 months, 9 months
Secondary	Daily living activities measured with Barthel Test	Measured with Barthel Test	3 months, 6 months, 9 months
Secondary	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
Secondary	Intervention Perception measured with Qualitative interview	Qualitative interview	3 months