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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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