Older Adults Without Any Specific Clinical ConditionNCT05460039
Impact of a Technology Mediated Dance Intervention
A study testing Dance mediated by tecnhology in people with Older Adults Without Any Specific Clinical Condition, run by Aveiro University at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults Without Any Specific Clinical Condition
- What is being tested?
- Dance mediated by tecnhology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePortugal
- Study dates
- 19 Jul 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- Reporting cardiovascular pathology that limits the performance of the dance or dizziness or imbalance prior to using the mat
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Dance mediated by tecnhology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance mediated by tecnhologyOther
A web system and a dance mat are used to stimulate participants to perform dance activities for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Usual activities | No intervention | This group will receive no intervention. |
| DanceMove | Experimental | This group will perform dance sessions mediated by technology (a dance mat and a web platform). Receives: Other: Dance mediated by tecnhology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait velocity
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.
Measured: Baseline
Gait velocity
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.
Measured: After the intervention (8 weeks after baseline assessment)
Gait velocity
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.
Measured: At 3 months follow up
Secondary outcomes (24)
Balance
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.
Measured: Baseline
Balance
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.
Measured: After the intervention (8 weeks after baseline assessment)
Balance
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.
Measured: At 3 months follow up
Cognitive functioning
This will be measured using the Trail Making Test which is a paper-based test; score is given in seconds.
Measured: Baseline
Cognitive functioning
This will be measured using the Trail Making Test which is a paper-based test; score is given in seconds.
Measured: After the intervention (8 weeks after baseline assessment)
Cognitive functioning
This will be measured using the Trail Making Test which is a paper-based test; score is given in seconds.
Measured: At 3 months follow up
Pain intensity
Measured with a 100 mm Vertical Numeric Pain Rating Scale, anchored with 0 (no pain) and 100 (worst possible pain)
Measured: Baseline
Pain intensity
Measured with a 100 mm Vertical Numeric Pain Rating Scale, anchored with 0 (no pain) and 100 (worst possible pain)
Measured: After the intervention (8 weeks after baseline assessment)
Pain intensity
Measured with a 100 mm Vertical Numeric Pain Rating Scale, anchored with 0 (no pain) and 100 (worst possible pain)
Measured: At 3 months follow up
Quality of life
Measured using the WHOQOL-Bref (WHO Quality of Life questionnaire); scores range between 0 to 20 and higher scores indicate better quality of life
Measured: Baseline
Quality of life
Measured using the WHOQOL-Bref (WHO Quality of Life questionnaire); scores range between 0 to 20 and higher scores indicate better quality of life
Measured: After the intervention (8 weeks after baseline assessment)
Quality of life
Measured using the WHOQOL-Bref (WHO Quality of Life questionnaire); scores range between 0 to 20 and higher scores indicate better quality of life
Measured: At 3 months follow up
Health status
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)
Measured: Baseline
Health status
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)
Measured: After the intervention (8 weeks after baseline assessment)
Health status
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)
Measured: At 3 months follow up
Self-efficacy
Measured using the Perceived Self-Efficacy Scale; scores vary between 10 and 40 and higher scores indicate higher self-efficacy
Measured: Baseline
Self-efficacy
Measured using the Perceived Self-Efficacy Scale; scores vary between 10 and 40 and higher scores indicate higher self-efficacy
Measured: After the intervention (8 weeks after baseline assessment)
Self-efficacy
Measured using the Perceived Self-Efficacy Scale; scores vary between 10 and 40 and higher scores indicate higher self-efficacy
Measured: At 3 months follow up
Loneliness
Measured using the University of California, Los Angeles, Loneliness Scale; scores vary between 4 and 28 and higher scores indicate higher loneliness
Measured: Baseline
Loneliness
Measured using the University of California, Los Angeles, Loneliness Scale; scores vary between 4 and 28 and higher scores indicate higher loneliness
Measured: After the intervention (8 weeks after baseline assessment)
Loneliness
Measured using the University of California, Los Angeles, Loneliness Scale; scores vary between 4 and 28 and higher scores indicate higher loneliness
Measured: At 3 months follow up
Social support
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
Measured: Baseline
Social support
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
Measured: After the intervention (8 weeks after baseline assessment)
Social support
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
Measured: At 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start19 Jul 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older Adults Without Any Specific Clinical ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
- Investigators
- Anabela Silva, Principal investigator, School of Health Sciences, University of Aveiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460039
- Sponsor's protocol ID
- DanceMove
- Status last verified
- Feb 2024
- First submitted
- 14 Jul 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva AG, Martins AI, Andias R, Nery E, Silva T, Ribeiro O, Santinha G, Rocha NP. A web step-based digital solution's impact on physical, cognitive and psychosocial functioning of community-dwelling older adults: A mixed methods randomized and controlled trial. Internet Interv. 2024 Aug 21;38:100766. doi: 10.1016/j.invent.2024.100766. eCollection 2024 Dec.
PubMed 39280041
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-mediated Dance: Impact on Psychossocial, Physical, and Cognitive Functions of the Old
- ClinicalTrials.gov ID
- NCT05460039
- Acronym / sponsor ID
- DanceMove
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual activities | No intervention | –This group will receive no intervention. |
| DanceMove | Experimental | Other: Dance mediated by tecnhologyThis group will perform dance sessions mediated by technology (a dance mat and a web platform). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Reporting cardiovascular pathology that limits the performance of the dance or dizziness or imbalance prior to using the mat
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance mediated by tecnhologyA web system and a dance mat are used to stimulate participants to perform dance activities for 8 weeks. | Other | DanceMove |
Primary outcome
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.
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.
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.
24 secondary outcomes
Balance
Time frame: Baseline
Balance
Time frame: After the intervention (8 weeks after baseline assessment)
Balance
Time frame: At 3 months follow up
Cognitive functioning
Time frame: Baseline
Cognitive functioning
Time frame: After the intervention (8 weeks after baseline assessment)
Cognitive functioning
Time frame: At 3 months follow up
Pain intensity
Time frame: Baseline
Pain intensity
Time frame: After the intervention (8 weeks after baseline assessment)
Pain intensity
Time frame: At 3 months follow up
Quality of life
Time frame: Baseline
Quality of life
Time frame: After the intervention (8 weeks after baseline assessment)
Quality of life
Time frame: At 3 months follow up
Health status
Time frame: Baseline
Health status
Time frame: After the intervention (8 weeks after baseline assessment)
Health status
Time frame: At 3 months follow up
Self-efficacy
Time frame: Baseline
Self-efficacy
Time frame: After the intervention (8 weeks after baseline assessment)
Self-efficacy
Time frame: At 3 months follow up
Loneliness
Time frame: Baseline
Loneliness
Time frame: After the intervention (8 weeks after baseline assessment)
Loneliness
Time frame: At 3 months follow up
Social support
Time frame: Baseline
Social support
Time frame: After the intervention (8 weeks after baseline assessment)
Social support
Time frame: At 3 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 39280041Silva AG, Martins AI, Andias R, Nery E, Silva T, Ribeiro O, Santinha G, Rocha NP. A web step-based digital solution's impact on physical, cognitive and psychosocial functioning of community-dwelling older adults: A mixed methods randomized and controlled trial. Internet Interv. 2024 Aug 21;38:100766. doi: 10.1016/j.invent.2024.100766. eCollection 2024 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anabela Silva principal investigator
School of Health Sciences, University of Aveiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance mediated by tecnhology in people with Older Adults Without Any Specific Clinical Condition, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait velocity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05460039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.