Relationship Between the Risk of Falls and Frailty, and the Effect of a Physical Exercise Program on These Conditions in the Elderly: a Randomized Crossover Clinical Trial.

NCT ID: NCT05940779

Last Updated: 2023-07-11

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-22

Study Completion Date

2024-09-30

Brief Summary

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The goal of this randomized crossover clinical trial is to examine the effectiveness of a new therapeutic exercise program in elderly patients with risk of falls and physical fragility. The main questions it aims to answer are:

* If the therapeutic exercise program proposed is a successful treatment for this kind of patients
* If patients at risk of falls also suffer from pre-frailty or frailty, and if they can be treated together with the proposed therapy.

Participants will follow a program consisting of exercises to correct posture, gain strength and contribute to greater balance.

Researchers will compare the therapy and control groups to see if the program increases the percentage of muscle mass of participants, their mobility, balance, quality of life and if they reduce their Fried´s frailty criteria, fear of falling and falls compared to their usual physical activity.

Detailed Description

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Conditions

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Frail Elderly Syndrome Fall

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Exercise group

Group Type EXPERIMENTAL

Therapeutic exercise program

Intervention Type OTHER

The intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Therapeutic exercise program

The intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Community dwelling older adults.
* Independent for ambulation.
* With a cognitive state that do not prevent understand the researcher indications.
* Not performing regular physical exercise (only basic activities of daily living, but no other type of intervention).

Exclusion Criteria

* Contraindication of physical exercise.
* Evident impaired cognitive state.
* Vestibular or central nervous system affection.
* Can´t speak and understand spanish correctly.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Valencia

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Belén Quel Tejón

Role: CONTACT

675760137

José María Blasco Igual

Role: CONTACT

963983855

Facility Contacts

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José María Blasco Igual

Role: primary

963983855

Other Identifiers

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H1504602336419

Identifier Type: -

Identifier Source: org_study_id

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