- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04681976
Telematic Dance Intervention on Quality of Life of Older
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Valencia, Spain, 46009
- University of Valencia - Faculty of Physiotherapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Intervention Group participants will perform a 3-month telematic dance program based on choreographic work, 2 times per week
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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. |
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No Intervention: Control group
Control group will follow their daily routine without added exercise
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What is the study measuring?
Primary Outcome Measures
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).
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0-3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence
Time Frame: 0-3 months
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Measurement of adherence (expressed in % of assistance to the 24 sessions) to the 3-month telematic dance program.
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0-3 months
|
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Body composition
Time Frame: 0-3 months
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Changes on body composition (measured by bioimpedance in %) generated by 3-month telematic dance program
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0-3 months
|
|
Balance
Time Frame: 0-3 months
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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).
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0-3 months
|
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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).
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0-3 months
|
|
Level of physical activity
Time Frame: 0-3-6 months
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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
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0-3-6 months
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Mood
Time Frame: 0-3-6 months
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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.
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0-3-6 months
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Functionality
Time Frame: 0-3 months
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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.
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0-3 months
|
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Knee extension isometric strength
Time Frame: 0-3 months
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Changes produced in knee extension isometric strength measured with dynamometer (N) by a 3-month telematic dance program
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0-3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francisco Martínez-Arnau, PhD, Universitat de Valencia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1493554
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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