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

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.

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

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.
70

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

  • Portugal
      • Aveiro, Portugal
        • School of Health Sciences

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

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

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.
No Intervention: Usual activities
This group will receive no intervention.
Experimental: DanceMove
This group will perform dance sessions mediated by technology (a dance mat and a web platform).
Other: Dance mediated by tecnhology
A web system and a dance mat are used to stimulate participants to perform dance activities for 8 weeks.

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
Gait velocity
Time Frame: Baseline
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.
Baseline
Gait velocity
Time Frame: After the intervention (8 weeks after baseline assessment)
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.
After the intervention (8 weeks after baseline assessment)
Gait velocity
Time Frame: At 3 months follow up
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.
At 3 months follow up

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
Balance
Time Frame: Baseline
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.
Baseline
Balance
Time Frame: After the intervention (8 weeks after baseline assessment)
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.
After the intervention (8 weeks after baseline assessment)
Balance
Time Frame: At 3 months follow up
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.
At 3 months follow up
Cognitive functioning
Time Frame: Baseline
This will be measured using the Trail Making Test which is a paper-based test; score is given in seconds.
Baseline
Cognitive functioning
Time Frame: After the intervention (8 weeks after baseline assessment)
This will be measured using the Trail Making Test which is a paper-based test; score is given in seconds.
After the intervention (8 weeks after baseline assessment)
Cognitive functioning
Time Frame: At 3 months follow up
This will be measured using the Trail Making Test which is a paper-based test; score is given in seconds.
At 3 months follow up
Pain intensity
Time Frame: Baseline
Measured with a 100 mm Vertical Numeric Pain Rating Scale, anchored with 0 (no pain) and 100 (worst possible pain)
Baseline
Pain intensity
Time Frame: After the intervention (8 weeks after baseline assessment)
Measured with a 100 mm Vertical Numeric Pain Rating Scale, anchored with 0 (no pain) and 100 (worst possible pain)
After the intervention (8 weeks after baseline assessment)
Pain intensity
Time Frame: At 3 months follow up
Measured with a 100 mm Vertical Numeric Pain Rating Scale, anchored with 0 (no pain) and 100 (worst possible pain)
At 3 months follow up
Quality of life
Time Frame: Baseline
Measured using the WHOQOL-Bref (WHO Quality of Life questionnaire); scores range between 0 to 20 and higher scores indicate better quality of life
Baseline
Quality of life
Time Frame: After the intervention (8 weeks after baseline assessment)
Measured using the WHOQOL-Bref (WHO Quality of Life questionnaire); scores range between 0 to 20 and higher scores indicate better quality of life
After the intervention (8 weeks after baseline assessment)
Quality of life
Time Frame: At 3 months follow up
Measured using the WHOQOL-Bref (WHO Quality of Life questionnaire); scores range between 0 to 20 and higher scores indicate better quality of life
At 3 months follow up
Health status
Time Frame: Baseline
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)
Baseline
Health status
Time Frame: After the intervention (8 weeks after baseline assessment)
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)
After the intervention (8 weeks after baseline assessment)
Health status
Time Frame: At 3 months follow up
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)
At 3 months follow up
Self-efficacy
Time Frame: Baseline
Measured using the Perceived Self-Efficacy Scale; scores vary between 10 and 40 and higher scores indicate higher self-efficacy
Baseline
Self-efficacy
Time Frame: After the intervention (8 weeks after baseline assessment)
Measured using the Perceived Self-Efficacy Scale; scores vary between 10 and 40 and higher scores indicate higher self-efficacy
After the intervention (8 weeks after baseline assessment)
Self-efficacy
Time Frame: At 3 months follow up
Measured using the Perceived Self-Efficacy Scale; scores vary between 10 and 40 and higher scores indicate higher self-efficacy
At 3 months follow up
Loneliness
Time Frame: Baseline
Measured using the University of California, Los Angeles, Loneliness Scale; scores vary between 4 and 28 and higher scores indicate higher loneliness
Baseline
Loneliness
Time Frame: After the intervention (8 weeks after baseline assessment)
Measured using the University of California, Los Angeles, Loneliness Scale; scores vary between 4 and 28 and higher scores indicate higher loneliness
After the intervention (8 weeks after baseline assessment)
Loneliness
Time Frame: At 3 months follow up
Measured using the University of California, Los Angeles, Loneliness Scale; scores vary between 4 and 28 and higher scores indicate higher loneliness
At 3 months follow up
Social support
Time Frame: Baseline
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
Baseline
Social support
Time Frame: After the intervention (8 weeks after baseline assessment)
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
After the intervention (8 weeks after baseline assessment)
Social support
Time Frame: At 3 months follow up
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
At 3 months follow up

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.
Aveiro University

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: 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)

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.
July 19, 2022

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.
November 30, 2023

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.
November 30, 2023

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).
July 14, 2022

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.
July 14, 2022

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.
July 15, 2022

Study Record Updates

Last Update Posted (Estimated)

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.
February 6, 2024

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.
February 5, 2024

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.
February 1, 2024

More Information

Terms related to this study

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.
  • 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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