Dance Therapy WorkshopUnidanceNCT05436574
Impact of the Implementation of Dance Therapy Workshops on the Quality of Life of Dependent Elderly People Institutionalized Within the Establishments of the Univi Group
A study testing Dance therapy in people with Dance Therapy Workshop, run by Centre Médical Porte Verte.
Trial summary
Dance is a multimodal activity involving motor, cognitive, sensory and sensory-motor skills as well as emotional and social skills. A growing body of research shows that the creative arts and physical exercise are able to alleviate disability, improve social interactions, and slow the progression of Alzheimer's… Read more about this study
- Who is it for?
- Ages 60 to 110 years
- Conditions the study is for
- Dance Therapy Workshop
- What is being tested?
- Dance therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 940 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 31 Mar 2024
- 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 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People aged over 60
- Dependent elderly people residing in EHPAD or USLD including people under guardianship and curatorship
- People having signed an informated and weitten consent
- People with a minimum of language skills to understand instructions and simple questions
Who cannot join
- Participants in palliative care
- Contraindication to the practice of dance
- Severe cognitive and/or behavioral disorders that do not allow you to follow a dance workshop
- Permanent bed rest
- Non-affiliation to a social security scheme
About this study
Official title: Impact of the Implementation of Dance Therapy Workshops on the Quality of Life of Dependent Elderly People Institutionalized Within the Establishments of the Univi Group: Longitudinal Intervention Study
Dance is a multimodal activity involving motor, cognitive, sensory and sensory-motor skills as well as emotional and social skills. A growing body of research shows that the creative arts and physical exercise are able to alleviate disability, improve social interactions, and slow the progression of Alzheimer's disease and related disorders.
The Associative Group UNIVI wants to evaluate through this study the effects of the practice of dance on the quality of life of the people accommodated in its USLD and EHPAD
Read the detailed description
This research is an interventional study involving the human person of category 2 involving only minimal risks and constraints, it is multicentric and longitudinal prospective. This is a before/after study to measure the effects of the implementation of a dance therapy activity on the quality of life of the elderly population housed in the 30 establishments of the univi group.
The dance therapy will be deployed in all the medico-social establishments participating in the study over a period of 12 weeks.
To do this, dance therapists will be recruited to provide these classes.
The dance-therapy will be carried out:
- in groups of 10 to 12 people who have given their informed consent,
- at least twice a week per group,
- over a period of 30 to 45 minutes maximum twice a week for 3 months. Several groups per establishment can be planned depending on the number of people who can and want to be included in the dance workshop. 940 participant in the study will be inclued and followed at 1 month, 3 months and 6 months after the end of the dance therapy workshops.
- Conditions
- Dance Therapy Workshop
- Being tested
- Dance therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance therapyOther
Before/after study to measure the effects of the dance therapy activity on the quality of life of the elderly population housed in the establishments of UNIVI group.
| Study group | Role | What they receive |
|---|---|---|
| Before/after study | Other | Before/after study to measure the effects of the implementation of a dance therapy activity on the quality of life of the elderly population Receives: Other: Dance therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
QOL-AD NH scale
The QOL-AD is a brief 13-item measure designed specifically to obtain an assessment of the patient's quality of life from both the patient and the caregiver.
It was developed for people with dementia, based on feedback from patients, caregivers and experts, to maximize construct validity and ensure measurement focuses on areas of quality of considered important in older adults with cognitive impairment The measurement of 13 items, rated on a four-point scale, of which 1 is poor and 4 excellent. Total partitions range from 13 to 52.
Measured: Eight months
Secondary outcomes (5)
Tinetti test: assessement of walking and balance
The Tinetti test is an effective and reproductible tool for the assessement of the risk of falling, its administration time is approximately 5 to 10 minutes and evaluates static and dynamic balance
Measured: Eight months
Get up and Go test
This test evaluates the transfers sitting, standing, walking and changes of direction of the person. . Interpretation: risk of falling if score greater than or equal to 9
Measured: Eight months
Time up and Go test
The time up and go test is the timed version of the get up and go test. The subject seated on a chair must get up, walk 3 meters in front of him, return to his chair and sit down. The score is given by the time in seconds.
Interpretation: risk of falling if the score is greater than or equal to 21 seconds.
Measured: Eignt months
NPI-ES: NEUROPSYCHIATRIC INVENTORY
assesses the presence of behavioral problems in people with dementia. . a score of Ten behavioral domains and 2 neurovegetative variables are taken into account.
Measured: Eight months
The mini GDS
The mini GDS (Geriatric Depression Scale) aims to identify the person's risk of depression. It consists of 4 simple questions that must be answered with "yes" or "no".
Measured: Eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dance Therapy WorkshopStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 940 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Médical Porte Verte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valérie BRENIERE, Centre Médical Porte Verte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436574
- Sponsor's protocol ID
- 2022-A01255-38
- Acronym
- Unidance
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Implementation of Dance Therapy Workshops on the Quality of Life of Dependent Elderly People Institutionalized Within the Establishments of the Univi Group: Longitudinal Intervention Study
- ClinicalTrials.gov ID
- NCT05436574
- Acronym / sponsor ID
- Unidance / 2022-A01255-38
- Conditions
- Dance Therapy Workshop
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 940 participants (estimated)
- Lead sponsor
- Centre Médical Porte VerteUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 29 Jun 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.
Dance is a multimodal activity involving motor, cognitive, sensory and sensory-motor skills as well as emotional and social skills. A growing body of research shows that the creative arts and physical exercise are able to alleviate disability, improve social interactions, and slow the progression of Alzheimer's disease and related disorders.
The Associative Group UNIVI wants to evaluate through this study the effects of the practice of dance on the quality of life of the people accommodated in its USLD and EHPAD
Detailed description
This research is an interventional study involving the human person of category 2 involving only minimal risks and constraints, it is multicentric and longitudinal prospective. This is a before/after study to measure the effects of the implementation of a dance therapy activity on the quality of life of the elderly population housed in the 30 establishments of the univi group.
The dance therapy will be deployed in all the medico-social establishments participating in the study over a period of 12 weeks.
To do this, dance therapists will be recruited to provide these classes.
The dance-therapy will be carried out:
- in groups of 10 to 12 people who have given their informed consent,
- at least twice a week per group,
- over a period of 30 to 45 minutes maximum twice a week for 3 months. Several groups per establishment can be planned depending on the number of people who can and want to be included in the dance workshop. 940 participant in the study will be inclued and followed at 1 month, 3 months and 6 months after the end of the dance therapy workshops.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Before/after study | Other | Other: Dance therapyBefore/after study to measure the effects of the implementation of a dance therapy activity on the quality of life of the elderly population |
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People aged over 60
- Dependent elderly people residing in EHPAD or USLD including people under guardianship and curatorship
- People having signed an informated and weitten consent
- People with a minimum of language skills to understand instructions and simple questions
Key exclusion criteria (5 listed)
- Participants in palliative care
- Contraindication to the practice of dance
- Severe cognitive and/or behavioral disorders that do not allow you to follow a dance workshop
- Permanent bed rest
- Non-affiliation to a social security scheme
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 therapyBefore/after study to measure the effects of the dance therapy activity on the quality of life of the elderly population housed in the establishments of UNIVI group. | Other | Before/after study |
Primary outcome
QOL-AD NH scale
Time frame: Eight months
The QOL-AD is a brief 13-item measure designed specifically to obtain an assessment of the patient's quality of life from both the patient and the caregiver. It was developed for people with dementia, based on feedback from patients, caregivers and experts, to maximize construct validity and ensure measurement focuses on areas of quality of considered important in older adults with cognitive impairment The measurement of 13 items, rated on a four-point scale, of which 1 is poor and 4 excellent. Total partitions range from 13 to 52.
5 secondary outcomes
Tinetti test: assessement of walking and balance
Time frame: Eight months
Get up and Go test
Time frame: Eight months
Time up and Go test
Time frame: Eignt months
NPI-ES: NEUROPSYCHIATRIC INVENTORY
Time frame: Eight months
The mini GDS
Time frame: Eight months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dance therapy in people with Dance Therapy Workshop, run by Centre Médical Porte Verte.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
QOL-AD NH scale (time frame: Eight 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 29 Jun 2022.