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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04681976
Other study ID # 1493554
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 11, 2021
Est. completion date September 27, 2021

Study information

Verified date September 2021
Source University of Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 27, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Spain University of Valencia - Faculty of Physiotherapy Valencia

Sponsors (1)

Lead Sponsor Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in quality of Life 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 Adherence Measurement of adherence (expressed in % of assistance to the 24 sessions) to the 3-month telematic dance program. 0-3 months
Secondary Body composition Changes on body composition (measured by bioimpedance in %) generated by 3-month telematic dance program 0-3 months
Secondary Balance 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
Secondary Fear of falling 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
Secondary Level of physical activity 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
Secondary Mood 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
Secondary Functionality 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
Secondary Knee extension isometric strength Changes produced in knee extension isometric strength measured with dynamometer (N) by a 3-month telematic dance program 0-3 months
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