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Completed

NCT Number: NCT03019211

Feasibility Aquatic Physical Exercise to Reduce Falls in Institutionalized Elderly

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.

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Key information

Conditions

Age Problems Cognition Disorders Cognitive Dysfunction Cognitive Impairment Elderly Mental Disorders Neurocognitive Disorders Postural Balance Strength

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Ramon Llull

Barcelona, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

Primary outcomes

  1. 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

  1. Balance measured with Performance Oriented Mobility Assessment

    Time frame: 3 months, 6 months, 9 months

    Measured with Performance Oriented Mobility Assessment

  2. Pain measured with Visual Analogue Scale

    Time frame: 3 months, 6 months, 9 months

    Measured with Visual Analogue Scale

  3. Mobility measured with Timed Up & Go Test

    Time frame: 3 months, 6 months, 9 months

    Measured with Timed Up & Go Test

  4. Daily living activities measured with Barthel Test

    Time frame: 3 months, 6 months, 9 months

    Measured with Barthel Test

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

    Time frame: 3 months, 6 months, 9 months

    Measured with Five Sit to Stand test and Handgrip Test

  6. Intervention Perception measured with Qualitative interview

    Time frame: 3 months

    Qualitative interview

Sponsors and collaborators

Lead sponsor

University Ramon Llull

Other

Collaborators

  • Residencial Augusta Park
  • Sanitas Mayores Les Corts

Registry information

Official study 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

Acronym: PrePhysFalls

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2017
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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