Feasibility Aquatic Physical Exercise to Reduce Falls in Institutionalized Elderly

NCT ID: NCT03019211

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Age Problems Cognitive Impairment Elderly Postural Balance Strength

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanitas Mayores Les Corts

UNKNOWN

Sponsor Role collaborator

Residencial Augusta Park

UNKNOWN

Sponsor Role collaborator

University Ramon Llull

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mercè Sitjà Rabert, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

University Ramon Llull

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitat Ramon Llull

Barcelona, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PrePhysFalls

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Multifactorial Fall Prevention Program
NCT05682872 ACTIVE_NOT_RECRUITING NA