Telematic Dance Intervention on Quality of Life of Older

September 27, 2021 updated by: Francisco Martínez Arnau, University of Valencia

Effectiveness of a Telematic Dance Intervention on the Quality of Life of Older People: Randomized Clinical Trial

The aim of this study is to analyse the effectiveness of a telematic dance intervention on the quality of life of older people.

This project is a controlled, randomized clinical trial. 54 people (Intervention Group, n=27; Control Group, n=27) between the ages of 60-80 will participate in the study.

Intervention Group participants will perform a 3-month telematic dance program based on choreographic work. The participants shall be measured 3 times, at baseline, post-intervention, and at 6-month post-intervention follow-up. Aside from the quality of life, variables of balance, risk of falling, number of falls, level of physical activity, mood, functionality, comorbidity, and quadriceps strength will also be measured.

Study Overview

Status

Status

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

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 (Actual)

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.
60

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 Locations

  • Spain
      • Valencia, Spain, 46009
        • University of Valencia - Faculty of Physiotherapy

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

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 60-80.
  • Owning a device that can connect to internet to visualize videos and do videocalls, in case a session to resolve doubts is necessary.

Exclusion Criteria:

  • Subjects with degenerative or cognitive pathologies
  • Subjects with severe visual deficiencies.
  • Subjects with any acute pain.
  • Subjects with inability to stand.
  • Subjects with any medical contraindication to exercise (cardiovascular risk factors).
  • Subjects incapable of managing telematic devices to follow the sessions.
  • Subjects who refuse to sign the informed consent.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Experimental: Intervention group
Intervention Group participants will perform a 3-month telematic dance program based on choreographic work, 2 times per week
Behavioral: Telematic dance program

Telematic dance program

The dance program will consist of 24 sessions distributed twice a week for a total period of 3 months. Each session will include:

A) Warm up: It will consist of analytical and global movements of increasing intensity and stretching exercises. It will also involve body awareness and motor control exercises.

B) Choreography part: the participants must follow and learn the choreographies. Intensity ranges shall vary between low and moderate. (3-4 in Borg's Modified Scale (0-10)).

C) Cool down: It will consist of global movements of decreasing intensity, stretching, breathing, and relaxing exercises.
No Intervention: Control group
Control group will follow their daily routine without added exercise

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
Changes in quality of Life
Time Frame: 0-3 months
Changes produced by a 3-month telematic dance program related to quality of life (EuroQol 5 Dimensions - 3 levels Index, 0 to 1 point, higher values = better outcome).
0-3 months

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
Adherence
Time Frame: 0-3 months
Measurement of adherence (expressed in % of assistance to the 24 sessions) to the 3-month telematic dance program.
0-3 months
Body composition
Time Frame: 0-3 months
Changes on body composition (measured by bioimpedance in %) generated by 3-month telematic dance program
0-3 months
Balance
Time Frame: 0-3 months
Changes on balance produced by a 3-month dance program measured by Timed Up and Go Test (measured in seconds) and one single leg stance test (measured in seconds).
0-3 months
Fear of falling
Time Frame: 0-3 months
Changes on fear of falling measured by Falls Efficacy Scale-International (16 items measured by 4 point Lickert scale; 1= not worried, 4= very worried, (0-64)), and number of falls (retractive, 3 previous months and prospective, 3 following months).
0-3 months
Level of physical activity
Time Frame: 0-3-6 months
Changes in the level of physical activity measured by the International Physical Activity Questionnaire (IPAQ) (expressed in minutes) produced by a 3-month telematic dance program
0-3-6 months
Mood
Time Frame: 0-3-6 months
Changes in mood measured by the Mood Evaluation Scale (16 items measured in Likert scales (0-10)) produced by a 3-month telematic dance program.
0-3-6 months
Functionality
Time Frame: 0-3 months
Changes in functionality and independence measured by Barthel Index (0 to 100 points, < 60 dependence, higher values = better outcome) produced by a 3-month telematic dance program.
0-3 months
Knee extension isometric strength
Time Frame: 0-3 months
Changes produced in knee extension isometric strength measured with dynamometer (N) by a 3-month telematic dance program
0-3 months

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francisco Martínez-Arnau, PhD, Universitat de 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.
January 11, 2021

Primary Completion (Actual)

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.
April 30, 2021

Study Completion (Actual)

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 27, 2021

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).
December 16, 2020

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.
December 22, 2020

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.
December 23, 2020

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.
September 28, 2021

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.
September 27, 2021

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.
September 1, 2021

More Information

Terms related to this study

Keywords

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.
  • 1493554

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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