Feasibility Aquatic Physical Exercise to Reduce Falls in Institutionalized Elderly

NCT03019211 | Completed DMC

• 1 other identifier: PrePhysFalls
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Problems; Cognitive Impairment; Elderly; Postural Balance; Strength

Keywords

Physical Therapy Modalities; Accidental Fall; Elderly; Hydrotherapy; Nursing Home

Outcome Measures

Primary Outcomes (1)

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

  Falls follow up

  3 months, 6 months, 9 months

Secondary Outcomes (6)

• Balance measured with Performance Oriented Mobility Assessment

  3 months, 6 months, 9 months

• Pain measured with Visual Analogue Scale

  3 months, 6 months, 9 months

• Mobility measured with Timed Up & Go Test

  3 months, 6 months, 9 months

• Daily living activities measured with Barthel Test

  3 months, 6 months, 9 months

• Muscle strength measured with Five Sit to Stand test and Handgrip Test

  3 months, 6 months, 9 months

Study Arms (2)

Hydrotherapy

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Exercise OTHER

Control; Hydrotherapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ramon Llull: lead
• Sanitas Mayores Les Corts: collaborator
• Residencial Augusta Park: collaborator

Study Sites (1)

Universitat Ramon Llull

Barcelona, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mercè Sitjà Rabert, PhD, PT

  University Ramon Llull

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2017
• First Posted: January 12, 2017
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 5, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)