- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05460039
Impact of a Technology Mediated Dance Intervention
February 5, 2024 updated by: Anabela G Silva, Aveiro University
Technology-mediated Dance: Impact on Psychossocial, Physical, and Cognitive Functions of the Old
This study aims to investigate whether a technology-mediated dance impacts on psychosocial, physical and cognitive functions of the old adults when compared to usual activities.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study aims to investigate whether a technology-mediated dance impacts on psychosocial, physical, and cognitive functions of old adults when compared to usual activities.
It will have two arms one of which will receive a dance mat and perform dance sessions for 8 weeks, while the other group will continue their usual activities.
Participants will be assessed for psychosocial, physical, and cognitive aspects at baseline, end of the intervention, and at 3 months follow-up.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- 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
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Aveiro, Portugal
- School of Health Sciences
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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
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- People living independently in the community
- 65 years old or older
- With no cognitive impairment defined based on the 6-item cognitive decline test [4]
- Independent at walking without walking aids
- Access to a personal computer and internet
- For older adults unable to use a computer, a patient or carer with digital literacy needs to be identified for the older adult to enter the study.
Exclusion Criteria:
- Reporting cardiovascular pathology that limits the performance of the dance or dizziness or imbalance prior to using the mat
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual activities
This group will receive no intervention.
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Experimental: DanceMove
This group will perform dance sessions mediated by technology (a dance mat and a web platform).
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A web system and a dance mat are used to stimulate participants to perform dance activities for 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait velocity
Time Frame: Baseline
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Assessed using the gait velocity test, i.e., the velocity of gait when walking in a straight line for 4 meters; it is measured in meters per second.
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Baseline
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Gait velocity
Time Frame: After the intervention (8 weeks after baseline assessment)
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Assessed using the gait velocity test, i.e., the velocity of gait when walking in a straight line for 4 meters; it is measured in meters per second.
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After the intervention (8 weeks after baseline assessment)
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Gait velocity
Time Frame: At 3 months follow up
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Assessed using the gait velocity test, i.e., the velocity of gait when walking in a straight line for 4 meters; it is measured in meters per second.
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At 3 months follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: Baseline
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Balance will be assessed through the Functional Reach Test, which measures the ability of a person to reach forward without moving the feet; it is measured in cm.
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Baseline
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Balance
Time Frame: After the intervention (8 weeks after baseline assessment)
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Balance will be assessed through the Functional Reach Test, which measures the ability of a person to reach forward without moving the feet; it is measured in cm.
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After the intervention (8 weeks after baseline assessment)
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Balance
Time Frame: At 3 months follow up
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Balance will be assessed through the Functional Reach Test, which measures the ability of a person to reach forward without moving the feet; it is measured in cm.
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At 3 months follow up
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Cognitive functioning
Time Frame: Baseline
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This will be measured using the Trail Making Test which is a paper-based test; score is given in seconds.
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Baseline
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Cognitive functioning
Time Frame: After the intervention (8 weeks after baseline assessment)
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This will be measured using the Trail Making Test which is a paper-based test; score is given in seconds.
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After the intervention (8 weeks after baseline assessment)
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Cognitive functioning
Time Frame: At 3 months follow up
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This will be measured using the Trail Making Test which is a paper-based test; score is given in seconds.
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At 3 months follow up
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Pain intensity
Time Frame: Baseline
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Measured with a 100 mm Vertical Numeric Pain Rating Scale, anchored with 0 (no pain) and 100 (worst possible pain)
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Baseline
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Pain intensity
Time Frame: After the intervention (8 weeks after baseline assessment)
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Measured with a 100 mm Vertical Numeric Pain Rating Scale, anchored with 0 (no pain) and 100 (worst possible pain)
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After the intervention (8 weeks after baseline assessment)
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Pain intensity
Time Frame: At 3 months follow up
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Measured with a 100 mm Vertical Numeric Pain Rating Scale, anchored with 0 (no pain) and 100 (worst possible pain)
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At 3 months follow up
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Quality of life
Time Frame: Baseline
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Measured using the WHOQOL-Bref (WHO Quality of Life questionnaire); scores range between 0 to 20 and higher scores indicate better quality of life
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Baseline
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Quality of life
Time Frame: After the intervention (8 weeks after baseline assessment)
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Measured using the WHOQOL-Bref (WHO Quality of Life questionnaire); scores range between 0 to 20 and higher scores indicate better quality of life
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After the intervention (8 weeks after baseline assessment)
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Quality of life
Time Frame: At 3 months follow up
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Measured using the WHOQOL-Bref (WHO Quality of Life questionnaire); scores range between 0 to 20 and higher scores indicate better quality of life
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At 3 months follow up
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Health status
Time Frame: Baseline
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Measured using the EuroQoL EQ-5D; scores range from 5 to 25 and higher scores; indicate lower quality of life (note: according to the EuroQol Research Foundation, EQ-5D is not an abbreviation and is the correct term to use in print or verbally)
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Baseline
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Health status
Time Frame: After the intervention (8 weeks after baseline assessment)
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Measured using the EuroQoL EQ-5D; scores range from 5 to 25 and higher scores; indicate lower quality of life (note: according to the EuroQol Research Foundation, EQ-5D is not an abbreviation and is the correct term to use in print or verbally)
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After the intervention (8 weeks after baseline assessment)
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Health status
Time Frame: At 3 months follow up
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Measured using the EuroQoL EQ-5D; scores range from 5 to 25 and higher scores; indicate lower quality of life (note: according to the EuroQol Research Foundation, EQ-5D is not an abbreviation and is the correct term to use in print or verbally)
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At 3 months follow up
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Self-efficacy
Time Frame: Baseline
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Measured using the Perceived Self-Efficacy Scale; scores vary between 10 and 40 and higher scores indicate higher self-efficacy
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Baseline
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Self-efficacy
Time Frame: After the intervention (8 weeks after baseline assessment)
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Measured using the Perceived Self-Efficacy Scale; scores vary between 10 and 40 and higher scores indicate higher self-efficacy
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After the intervention (8 weeks after baseline assessment)
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Self-efficacy
Time Frame: At 3 months follow up
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Measured using the Perceived Self-Efficacy Scale; scores vary between 10 and 40 and higher scores indicate higher self-efficacy
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At 3 months follow up
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Loneliness
Time Frame: Baseline
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Measured using the University of California, Los Angeles, Loneliness Scale; scores vary between 4 and 28 and higher scores indicate higher loneliness
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Baseline
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Loneliness
Time Frame: After the intervention (8 weeks after baseline assessment)
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Measured using the University of California, Los Angeles, Loneliness Scale; scores vary between 4 and 28 and higher scores indicate higher loneliness
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After the intervention (8 weeks after baseline assessment)
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Loneliness
Time Frame: At 3 months follow up
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Measured using the University of California, Los Angeles, Loneliness Scale; scores vary between 4 and 28 and higher scores indicate higher loneliness
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At 3 months follow up
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Social support
Time Frame: Baseline
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Measured with the Oslo Social Support Scale (OSSS-3) with Life Events Scale; score varies between 3 and 14 and higher scores indicate stronger social support
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Baseline
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Social support
Time Frame: After the intervention (8 weeks after baseline assessment)
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Measured with the Oslo Social Support Scale (OSSS-3) with Life Events Scale; score varies between 3 and 14 and higher scores indicate stronger social support
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After the intervention (8 weeks after baseline assessment)
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Social support
Time Frame: At 3 months follow up
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Measured with the Oslo Social Support Scale (OSSS-3) with Life Events Scale; score varies between 3 and 14 and higher scores indicate stronger social support
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At 3 months follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anabela Silva, School of Health Sciences, University of Aveiro
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)
July 19, 2022
Primary Completion (Actual)
November 30, 2023
Study Completion (Actual)
November 30, 2023
Study Registration Dates
First Submitted
July 14, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (Actual)
July 15, 2022
Study Record Updates
Last Update Posted (Estimated)
February 6, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- DanceMove
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
product manufactured in and exported from the U.S.
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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