Aging WellNCT04681976
Telematic Dance Intervention on Quality of Life of Older
A study testing Telematic dance program in people with Aging Well, run by University of Valencia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Well
- What is being tested?
- Telematic dance program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jan 2021to 27 Sep 2021
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Telematic Dance Intervention on the Quality of Life of Older People: Randomized Clinical Trial
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.
- Conditions
- Aging Well
- Being tested
- Telematic dance program
- Keywords
- older; dance; muscle strenght; quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telematic dance programBehavioural
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:
- 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.
- 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)).
- Cool down: It will consist of global movements of decreasing intensity, stretching, breathing, and relaxing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention Group participants will perform a 3-month telematic dance program based on choreographic work, 2 times per week Receives: Behavioral: Telematic dance program |
| Control group | No intervention | Control group will follow their daily routine without added exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 0-3 months
Secondary outcomes (8)
Adherence
Measurement of adherence (expressed in % of assistance to the 24 sessions) to the 3-month telematic dance program.
Measured: 0-3 months
Body composition
Changes on body composition (measured by bioimpedance in %) generated by 3-month telematic dance program
Measured: 0-3 months
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).
Measured: 0-3 months
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).
Measured: 0-3 months
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
Measured: 0-3-6 months
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.
Measured: 0-3-6 months
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.
Measured: 0-3 months
Knee extension isometric strength
Changes produced in knee extension isometric strength measured with dynamometer (N) by a 3-month telematic dance program
Measured: 0-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start11 Jan 2021
- Primary completion30 Apr 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Martínez Arnau, University of Valencia
- Investigators
- Francisco Martínez-Arnau, PhD, Principal investigator, Universitat de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681976
- Sponsor's protocol ID
- 1493554
- Status last verified
- Sep 2021
- First submitted
- 16 Dec 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Telematic Dance Intervention on the Quality of Life of Older People: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04681976
- Acronym / sponsor ID
- 1493554
- Conditions
- Aging Well
- Keywords
- older; dance; muscle strenght; quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 23 Dec 2020 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Telematic dance programIntervention Group participants will perform a 3-month telematic dance program based on choreographic work, 2 times per week |
| Control group | No intervention | –Control group will follow their daily routine without added exercise |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
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 |
|---|---|---|
| Telematic dance programTelematic 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. | Behavioural | Intervention group |
Primary outcome
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).
8 secondary outcomes
Adherence
Time frame: 0-3 months
Body composition
Time frame: 0-3 months
Balance
Time frame: 0-3 months
Fear of falling
Time frame: 0-3 months
Level of physical activity
Time frame: 0-3-6 months
Mood
Time frame: 0-3-6 months
Functionality
Time frame: 0-3 months
Knee extension isometric strength
Time frame: 0-3 months
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 28 Sep 2021.
- 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.
Francisco Martínez-Arnau, PhD principal investigator
Universitat de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telematic dance program in people with Aging Well, run by University of Valencia at 1 site in Spain.
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 2 inclusion and 7 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 28 Sep 2021. 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 Spain. 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?
Changes in quality of Life (time frame: 0-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2021.