NCT05744011

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

February 8, 2023

Last Update Submit

February 22, 2023

Conditions

Keywords

older adultscognitive impairmentdance movement therapyphysical performancetango-therapyquality of lifewell-beinggait

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    Before intervention/ after 1 month / after 3 months

  • Change from Baseline questionnaire on Quality of Life (QoL) at 1 and 3 months

    Before intervention/ after 1 month / after 3 months

  • Change from Baseline neuropsychiatric symptoms at 1 and 3 months

    Before intervention/ after 1 month / after 3 months

  • Change from Baseline signs and symptoms of major depression at 1 and 3 months

    Before intervention/ after 1 month / after 3 months

Study Arms (2)

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.

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

Other: Adapted Physical Activity

Interventions

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.

Also known as: dance-movement-therapy
Tango group

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.

Also known as: APA
Physical activity group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Over 65 years old
  • MMSE \< 21
  • agreed to participate
  • lived permanently in the nursing home
  • able to walk 10 meters without human assistance

You may not qualify if:

  • medical contraindications,
  • limited life expectancy
  • bedridden persons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier du Mont d'Or

Albigny-sur-Saône, France

COMPLETED

Ehpad Du Chg Le Val D'Or

Chasselay, 69380, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • France Mourey, Professor

    Inserm U1093, University of Burgundy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Renaud Jamet, Nurse

CONTACT

Lucia Bracco, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 24, 2023

Study Start

December 1, 2022

Primary Completion

June 16, 2023

Study Completion

September 29, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations