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Telematic Dance Intervention on Quality of Life of Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04681976
Recruitment Status : Completed
First Posted : December 23, 2020
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Francisco Martínez Arnau, University of Valencia

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Aging Well Behavioral: Telematic dance program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of a Telematic Dance Intervention on the Quality of Life of Older People: Randomized Clinical Trial
Actual Study Start Date : January 11, 2021
Actual Primary Completion Date : April 30, 2021
Actual Study Completion Date : September 27, 2021
Arms and Interventions
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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
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Adherence [ Time Frame: 0-3 months ]
    Measurement of adherence (expressed in % of assistance to the 24 sessions) to the 3-month telematic dance program.

  2. Body composition [ Time Frame: 0-3 months ]
    Changes on body composition (measured by bioimpedance in %) generated by 3-month telematic dance program

  3. 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).

  4. 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).

  5. 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

  6. 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.

  7. 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.

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681976


Locations
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Spain
University of Valencia - Faculty of Physiotherapy
Valencia, Spain, 46009
Sponsors and Collaborators
University of Valencia
Investigators
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Principal Investigator: Francisco Martínez-Arnau, PhD Universitat de Valencia
More Information
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Responsible Party: Francisco Martínez Arnau, Physiotherapist, PhD, University of Valencia
ClinicalTrials.gov Identifier: NCT04681976    
Other Study ID Numbers: 1493554
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francisco Martínez Arnau, University of Valencia:
older; dance; muscle strenght; quality of life