Old Age; DementiaNCT05744011
Tango for Older People With Dementia
A study testing Tango intervention and Adapted Physical Activity in people with Old Age; Dementia, run by University of Burgundy at 2 sites in France.
Trial summary
Cognitive impairment (CI) is the leading cause of loss of autonomy and has a huge impact on physical performance and quality of life (QOL) in older people. Pharmacological treatments currently available have modest efficacy at best. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Old Age; Dementia
- What is being tested?
- Tango intervention and Adapted Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2022to 29 Sep 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
- No healthy volunteers
- Older adult
Who may be able to join
- Over 65 years old
- MMSE < 21
- agreed to participate
- lived permanently in the nursing home
- able to walk 10 meters without human assistance
Who cannot join
- medical contraindications,
- limited life expectancy
- bedridden persons.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 1 recruiting
- Completed
Centre Hospitalier du Mont d'Or
Albigny-sur-Saône
- Recruiting
Ehpad Du Chg Le Val D'Or
Chasselay, 69380
Renaud Jamet, Nurse, (0033)0472081896 ext. 4574, r.jamet@ch-montdor.fr
Lucia Bracco, PhD Student, (0033)0786952449, lucia.bracco@u-bourgogne.fr
About this study
Official title: Effects of Tango on Older People With Dementia. Randomized Controlled Study.
Cognitive impairment (CI) is the leading cause of loss of autonomy and has a huge impact on physical performance and quality of life (QOL) in older people. Pharmacological treatments currently available have modest efficacy at best. Dance as both artistic and physical activity, combining emotions, social interaction, and sensory stimulation, therefore appears as a non-pharmacological intervention, which could contribute to the prevention of functional decline.
Among all the existing dances, tango occupies a special place because of the cultural and emotional resonance it carries, but also because of what it leads to motor mobilization (variations in the rhythm of walking, rotation of the belts, weight transfers…). These characteristics seem to make the tango an excellent tool for the rehabilitation of balance and gait, as well as for the prevention of the loss of autonomy in older adults with CI.
The objective of this study is to evaluate and compare the effectiveness of an intervention based on tango and classical physical activity.
Read the detailed description
CI is a major cause of loss of independence in older people. Alterations in balance and gait are very often present, these worsen the overall condition of the patient and are a sign of poor prognosis. Consequently, the quality of life of the patient and his family is severely affected. The pharmacological treatments currently available aim to alleviate the symptoms. Current data support the modest efficacy of these treatments at best. Non-pharmacological interventions (NPI) are key tools for improving physical performance, functional abilities, cognitive, psychological and social functioning. The benefits of NPIs are observed daily in the field. To be better known, recognized and deployed more widely, it is essential to evaluate their effects and their implementation in a scientific way by following the criteria of evidence-based medicine. Dancing is widely appreciated by older people. "It is both an artistic and physical activity that combines emotions, social interaction, sensory stimulation, thus creating enriched environmental conditions for the elderly". Tango in particular has been used as a therapeutic instrument for a long time. Its regular practice has benefits in many aspects of health and can have a positive impact on cognitive abilities, as it requires sustained attention. Studies on tango as a therapy in Parkinson's disease have shown its effectiveness in improving psychomotor and cognitive signs and especially in the quality of life. Numerous studies have demonstrated the benefits that dance-based interventions can bring, far outweighing the risk of falls they represent. From a motor point of view, tango is a moderate-intensity exercise in which static and dynamic postural control is stimulated. This dance, based on walking, proves to be an excellent tool for rehabilitation, prevention of falls, as well as for the prevention of functional decline in older people with CI.
Objectives: The general goal of this project is to analyze the effects of tango on physical abilities, gait and quality of life of older people with C
Secondary objectives:
- Evaluate the effectiveness of this type of program compared to traditional treatment.
- Refine the characteristics of effective management, concerning the dose, frequency, and duration of intervention.
- Analyze the effects of tango on the spatiotemporal parameters of walking.
General hypotheses: Various studies have highlighted the positive effects of tango face of different conditions, including Parkinson's disease. Based on these findings, the investigators hypothesize that tango interventions have a positive effect on physical abilities and quality of life in older adults with CI.
- Conditions
- Old Age; Dementia
- Being tested
- Tango intervention, Adapted Physical Activity
- Keywords
- older adults, cognitive impairment, dance movement therapy, physical performance, tango-therapy, quality of life, well-being, gait
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tango interventionOther
Also called dance-movement-therapy
The interventions will be implemented by ABB Reportages and will be carried out by nursing staff who had previously received training in therapeutic tango at the University of Burgundy.
A dance movement therapist and a musician will accompany the interventions twice a month.
Participants will attend a 1-hour tango session, twice a week for twelve weeks.
Adapted Physical ActivityOther
Also called APA
The intervention will be carried out by an Adapted Physical Activity professor and by nursing staff.
Music is prohibited during the sessions. Participants will attend a 1-hour APA, twice a week for twelve weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tango group | Experimental | Tango intervention 2 times/week
1 hour During 3 months Conducted by care staff who previously received training in therapeutic tango from the University of Burgundy. Receives: Other: Tango intervention |
| Physical activity group | Active comparator | Physical activity intervention 2 times/week
1 hour During 3 months No music Conducted by physical activity professor assisted by care staff Receives: Other: Adapted Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline physical abilities (balance, gait speed and lower limbs strength) at 1 and 3 months
Physical abilities will be measured with the Short Physical Performance Battery (SPPB). This test is composed of three evaluation criteria: balance, walking speed and sit to stand [23]. Specifically, during the balance test, the subject had to maintain each of three distinct positions for 10 seconds (feet together, semi-tandem and tandem). The failure of a step was the condition to start the second test, in which the subject walked 4 meters two consecutive times. The best score was retained. Finally, the time taken to complete the fastest 5 chair lifts without the help of the upper limbs was evaluated. At the end of the three tests, a score of a maximum of 12 points could be obtained.
Measured: Before intervention/ after 1 month / after 3 months
Change from Baseline general physical performance at 1 and 3 months
The Timed Up \& Go test (TUG) is a general physical performance test used to assess mobility, balance and locomotor performance in elderly people with balance disturbances.
The individual must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed at a comfortable and safe pace. One practice trial is permitted to allow the individual to familiarize him/herself with the task. Timing commences with the verbal instruction "go" and stops when the patient returns to seated position. The individual wears their regular footwear and is permitted to use their walking aid (cane/walker) with its use indicated on the data collection form. No physical assistance is given.
Measured: Before intervention/ after 1 month / after 3 months
Secondary outcomes (4)
Change from Baseline ability to perform activities of daily living (ADL) at 1 and 3 months
Ability to perform ADL will be measured using the Katz Index, consisting of a questionnaire assessing abilities in six activities of daily living (ADL): personal hygiene care, dressing, toilet use, locomotion, continence and eating. For each domain, the answer var-ies between: 1 (complete independence), 0.5 (partial independence) or 0 (absolute depend-ence). In total, an index of zero to six is obtained, where zero indicates the highest degree of dependence.
Measured: Before intervention/ after 1 month / after 3 months
Change from Baseline questionnaire on Quality of Life (QoL) at 1 and 3 months
QoL will be measured with the questionnaire Quality of Life in Alzheimer disease (QoL-AD).This questionnaire is administered directly to the participant, up to a severe stage of the disease, and to the main caregiver. The participant and caregiver ratings were combined into a weighted composite score: (2 × patient score + 1 × caregiver score)/3. Thus, the answers provided by the patient remain preponderant in this model. The QoL-AD comprises 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self, ability to carry out daily tasks, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.
Measured: Before intervention/ after 1 month / after 3 months
Change from Baseline neuropsychiatric symptoms at 1 and 3 months
neuropsychiatric symptoms will be evaluated using the Neuropsychiatric Inventory-Questionnaire (NPI-Q), which is an informant-based interview that assesses neuropsychiatric symptoms of the participant. NPI consists of 10 (or 12) items that are assayed with questions, subquestions, and ratings of frequency and severity.
Measured: Before intervention/ after 1 month / after 3 months
Change from Baseline signs and symptoms of major depression at 1 and 3 months
Signs and symptoms of major depression will be assessed with the Cornell Scale for Depression in Dementia (CSDD), which is a 19-item clinician-administered instrument that uses information from interviews with both the patient and a nursing staff member, a method suitable for demented patients. The scale has high interrater reliability (kw = 0.67), internal consistency (coefficient alpha: 0.84), and sensitivity. Total Cornell Scale scores correlate (0.83) with depressive subtypes of various intensity classified according to Research Diagnostic Criteria.
Measured: Before intervention/ after 1 month / after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Dec 2022
- Primary completion16 Jun 2023 (estimated)
- Study completion29 Sep 2023 (estimated)
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 Old Age; DementiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Burgundy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, France Mourey, University of Burgundy
- Investigators
- France Mourey, Professor, Principal investigator, Inserm U1093, University of Burgundy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744011
- Sponsor's protocol ID
- CERUBFC-2022-09-29-031
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bracco L, Pinto-Carral A, Hillaert L, Mourey F. Tango-therapy vs physical exercise in older people with dementia; a randomized controlled trial. BMC Geriatr. 2023 Oct 24;23(1):693. doi: 10.1186/s12877-023-04342-x.
PubMed 37875856
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tango on Older People With Dementia. Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT05744011
- Acronym / sponsor ID
- CERUBFC-2022-09-29-031
- Conditions
- Old Age; Dementia
- Keywords
- older adults, cognitive impairment, dance movement therapy, physical performance, tango-therapy, quality of life, well-being, gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of BurgundyUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 16 Jun 2023 (estimated)
- Study completion
- 29 Sep 2023 (estimated)
- First posted
- 24 Feb 2023 (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.
Cognitive impairment (CI) is the leading cause of loss of autonomy and has a huge impact on physical performance and quality of life (QOL) in older people. Pharmacological treatments currently available have modest efficacy at best. Dance as both artistic and physical activity, combining emotions, social interaction, and sensory stimulation, therefore appears as a non-pharmacological intervention, which could contribute to the prevention of functional decline.
Among all the existing dances, tango occupies a special place because of the cultural and emotional resonance it carries, but also because of what it leads to motor mobilization (variations in the rhythm of walking, rotation of the belts, weight transfers…). These characteristics seem to make the tango an excellent tool for the rehabilitation of balance and gait, as well as for the prevention of the loss of autonomy in older adults with CI.
The objective of this study is to evaluate and compare the effectiveness of an intervention based on tango and classical physical activity.
Detailed description
CI is a major cause of loss of independence in older people. Alterations in balance and gait are very often present, these worsen the overall condition of the patient and are a sign of poor prognosis. Consequently, the quality of life of the patient and his family is severely affected. The pharmacological treatments currently available aim to alleviate the symptoms. Current data support the modest efficacy of these treatments at best. Non-pharmacological interventions (NPI) are key tools for improving physical performance, functional abilities, cognitive, psychological and social functioning. The benefits of NPIs are observed daily in the field. To be better known, recognized and deployed more widely, it is essential to evaluate their effects and their implementation in a scientific way by following the criteria of evidence-based medicine. Dancing is widely appreciated by older people. "It is both an artistic and physical activity that combines emotions, social interaction, sensory stimulation, thus creating enriched environmental conditions for the elderly". Tango in particular has been used as a therapeutic instrument for a long time. Its regular practice has benefits in many aspects of health and can have a positive impact on cognitive abilities, as it requires sustained attention. Studies on tango as a therapy in Parkinson's disease have shown its effectiveness in improving psychomotor and cognitive signs and especially in the quality of life. Numerous studies have demonstrated the benefits that dance-based interventions can bring, far outweighing the risk of falls they represent. From a motor point of view, tango is a moderate-intensity exercise in which static and dynamic postural control is stimulated. This dance, based on walking, proves to be an excellent tool for rehabilitation, prevention of falls, as well as for the prevention of functional decline in older people with CI.
Objectives: The general goal of this project is to analyze the effects of tango on physical abilities, gait and quality of life of older people with C
Secondary objectives:
- Evaluate the effectiveness of this type of program compared to traditional treatment.
- Refine the characteristics of effective management, concerning the dose, frequency, and duration of intervention.
- Analyze the effects of tango on the spatiotemporal parameters of walking.
General hypotheses: Various studies have highlighted the positive effects of tango face of different conditions, including Parkinson's disease. Based on these findings, the investigators hypothesize that tango interventions have a positive effect on physical abilities and quality of life in older adults with CI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Tango group | Experimental | Other: Tango interventionTango intervention 2 times/week 1 hour During 3 months Conducted by care staff who previously received training in therapeutic tango from the University of Burgundy. |
| Physical activity group | Active comparator | Other: Adapted Physical ActivityPhysical activity intervention 2 times/week 1 hour During 3 months No music Conducted by physical activity professor assisted by care staff |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Over 65 years old
- MMSE < 21
- agreed to participate
- lived permanently in the nursing home
- able to walk 10 meters without human assistance
Key exclusion criteria (3 listed)
- medical contraindications,
- limited life expectancy
- bedridden persons.
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 |
|---|---|---|
| Tango interventionAlso: dance-movement-therapyThe interventions will be implemented by ABB Reportages and will be carried out by nursing staff who had previously received training in therapeutic tango at the University of Burgundy. A dance movement therapist and a musician will accompany the interventions twice a month. Participants will attend a 1-hour tango session, twice a week for twelve weeks. | Other | Tango group |
| Adapted Physical ActivityAlso: APAThe intervention will be carried out by an Adapted Physical Activity professor and by nursing staff. Music is prohibited during the sessions. Participants will attend a 1-hour APA, twice a week for twelve weeks. | Other | Physical activity group |
Primary outcome
Change from Baseline physical abilities (balance, gait speed and lower limbs strength) at 1 and 3 months
Time frame: Before intervention/ after 1 month / after 3 months
Physical abilities will be measured with the Short Physical Performance Battery (SPPB). This test is composed of three evaluation criteria: balance, walking speed and sit to stand [23]. Specifically, during the balance test, the subject had to maintain each of three distinct positions for 10 seconds (feet together, semi-tandem and tandem). The failure of a step was the condition to start the second test, in which the subject walked 4 meters two consecutive times. The best score was retained. Finally, the time taken to complete the fastest 5 chair lifts without the help of the upper limbs was evaluated. At the end of the three tests, a score of a maximum of 12 points could be obtained.
Change from Baseline general physical performance at 1 and 3 months
Time frame: Before intervention/ after 1 month / after 3 months
The Timed Up \& Go test (TUG) is a general physical performance test used to assess mobility, balance and locomotor performance in elderly people with balance disturbances. The individual must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed at a comfortable and safe pace. One practice trial is permitted to allow the individual to familiarize him/herself with the task. Timing commences with the verbal instruction "go" and stops when the patient returns to seated position. The individual wears their regular footwear and is permitted to use their walking aid (cane/walker) with its use indicated on the data collection form. No physical assistance is given.
4 secondary outcomes
Change from Baseline ability to perform activities of daily living (ADL) at 1 and 3 months
Time frame: Before intervention/ after 1 month / after 3 months
Change from Baseline questionnaire on Quality of Life (QoL) at 1 and 3 months
Time frame: Before intervention/ after 1 month / after 3 months
Change from Baseline neuropsychiatric symptoms at 1 and 3 months
Time frame: Before intervention/ after 1 month / after 3 months
Change from Baseline signs and symptoms of major depression at 1 and 3 months
Time frame: Before intervention/ after 1 month / after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Derived from this study: PubMed 37875856Bracco L, Pinto-Carral A, Hillaert L, Mourey F. Tango-therapy vs physical exercise in older people with dementia; a randomized controlled trial. BMC Geriatr. 2023 Oct 24;23(1):693. doi: 10.1186/s12877-023-04342-x.
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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.
France Mourey, Professor principal investigator
Inserm U1093, University of Burgundy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tango intervention and Adapted Physical Activity in people with Old Age; Dementia, run by University of Burgundy at 2 sites in France.
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 5 inclusion and 3 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 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renaud Jamet, Nurse ((0033)0472081896 ext. 4574, r.jamet@ch-montdor.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline physical abilities (balance, gait speed and lower limbs strength) at 1 and 3 months (time frame: Before intervention/ after 1 month / after 3 months). The study lists 2 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 NCT05744011, 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 24 Feb 2023; AzTrials last refreshed its copy on 3 Nov 2026.