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.

July 3, 2023 updated by: University of Valencia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Recruiting
        • University of Valencia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Exercise group
Other: Therapeutic exercise program
The intervention is a therapeutic program composed of self-resisted strength exercises, balance training and exercises to improve posture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go (TUG)
Time Frame: Assessed before the first intervention (baseline).
Assessed before the first intervention (baseline).
Timed Up and Go (TUG)
Time Frame: Assessed after the first intervention (3 months later).
Assessed after the first intervention (3 months later).
Timed Up and Go (TUG)
Time Frame: Assessed after the second intervention (3 months after the previous assessement).
Assessed after the second intervention (3 months after the previous assessement).
Timed Up and Go (TUG)
Time Frame: Assessed after 3 months from the previous assessement.
Assessed after 3 months from the previous assessement.
Fried frailty criteria
Time Frame: Assessed before the first intervention (baseline).
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Assessed before the first intervention (baseline).
Fried frailty criteria
Time Frame: Assessed after the first intervention (3 months later).
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Assessed after the first intervention (3 months later).
Fried frailty criteria
Time Frame: Assessed after the second intervention (3 months after the previous assessement).
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Assessed after the second intervention (3 months after the previous assessement).
Fried frailty criteria
Time Frame: Assessed after 3 months from the previous assessement.
The Fried frailty criteria are five: unintentional weight loss, muscular weakness, low resistance or tiredness, slow gait and low level of physical activity.
Assessed after 3 months from the previous assessement.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls and their consequences
Time Frame: Assessed before the first intervention (baseline).
The number of falls in the last year will be asked.
Assessed before the first intervention (baseline).
Falls and their consequences
Time Frame: Every two weeks from date of the first assessement until the date of the study completion, an average of 1 year.
A follow-up made with phone calls.
Every two weeks from date of the first assessement until the date of the study completion, an average of 1 year.
Berg Balance Scale (BBS)
Time Frame: Assessed before the first intervention (baseline).
From 0 to 56. It shows a better balance when the score is higher.
Assessed before the first intervention (baseline).
Berg Balance Scale (BBS)
Time Frame: Assessed after the first intervention (3 months later).
From 0 to 56. It shows a better balance when the score is higher.
Assessed after the first intervention (3 months later).
Berg Balance Scale (BBS)
Time Frame: Assessed after the second intervention (3 months after the previous assessement).
From 0 to 56. It shows a better balance when the score is higher.
Assessed after the second intervention (3 months after the previous assessement).
Berg Balance Scale (BBS)
Time Frame: Assessed after 3 months from the previous assessement.
From 0 to 56. It shows a better balance when the score is higher.
Assessed after 3 months from the previous assessement.
Falls Efficacy Scale-International (FES-I)
Time Frame: Assessed before the first intervention (baseline).
From 16 to 64. Higher scores show more concern of falling.
Assessed before the first intervention (baseline).
Falls Efficacy Scale-International (FES-I)
Time Frame: Assessed after the first intervention (3 months later).
From 16 to 64. Higher scores show more concern of falling.
Assessed after the first intervention (3 months later).
Falls Efficacy Scale-International (FES-I)
Time Frame: Assessed after the second intervention (3 months after the previous assessement).
From 16 to 64. Higher scores show more concern of falling.
Assessed after the second intervention (3 months after the previous assessement).
Falls Efficacy Scale-International (FES-I)
Time Frame: Assessed after 3 months from the previous assessement.
From 16 to 64. Higher scores show more concern of falling.
Assessed after 3 months from the previous assessement.
European Quality of Life-5 Dimensions (EuroQol-5D)
Time Frame: Assessed before the first intervention (baseline).

It has two parts:

The first one consists of questions about quality of life with scores from 0 to 1, higher if the quality of life of the patient is higher too.

The second one is a visual analogic scale (VAS) from 0 (worst quality of life) to 100 (bes quality of life).
Assessed before the first intervention (baseline).
European Quality of Life-5 Dimensions (EuroQol-5D)
Time Frame: Assessed after the first intervention (3 months later).

It has two parts:

The first one consists of questions about quality of life with scores from 0 to 1, higher if the quality of life of the patient is higher too.

The second one is a visual analogic scale (VAS) from 0 (worst quality of life) to 100 (bes quality of life).
Assessed after the first intervention (3 months later).
European Quality of Life-5 Dimensions (EuroQol-5D)
Time Frame: Assessed after the second intervention (3 months after the previous assessement).

It has two parts:

The first one consists of questions about quality of life with scores from 0 to 1, higher if the quality of life of the patient is higher too.

The second one is a visual analogic scale (VAS) from 0 (worst quality of life) to 100 (bes quality of life).
Assessed after the second intervention (3 months after the previous assessement).
European Quality of Life-5 Dimensions (EuroQol-5D)
Time Frame: Assessed after 3 months from the previous assessement.

It has two parts:

The first one consists of questions about quality of life with scores from 0 to 1, higher if the quality of life of the patient is higher too.

The second one is a visual analogic scale (VAS) from 0 (worst quality of life) to 100 (bes quality of life).
Assessed after 3 months from the previous assessement.
Muscle mass
Time Frame: Assessed before the first intervention (baseline).
Assessed with and impedance scale.
Assessed before the first intervention (baseline).
Muscle mass
Time Frame: Assessed after the first intervention (3 months later).
Assessed with and impedance scale.
Assessed after the first intervention (3 months later).
Muscle mass
Time Frame: Assessed after the second intervention (3 months after the previous assessement).
Assessed with and impedance scale.
Assessed after the second intervention (3 months after the previous assessement).
Muscle mass
Time Frame: Assessed after 3 months from the previous assessement.
Assessed with and impedance scale.
Assessed after 3 months from the previous assessement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2021

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1504602336419

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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