Clinical trial NCT05175365: The Impact of Dancing in Parkinson's Disease
Official title: Dance in Parkinson's Disease: An Optimized and Adapted Approach to Promote the Well-being and Functional Status of Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
Collaborators: name: Kinésiphilia
First posted: 2022-01-03
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study intends to confirm the results of previous studies showing the positive effect of dance on patients with Parkinson's disease on both mental and physical health via a randomized controlled trial. Patients will be randomized into the intervention group (dance courses in addition to standard care) or in the control group (standard care).

Detailed description: This is a clinical study on the benefits of dance in Parkinson's disease. In recent years, dance has become an interesting strategy to promote motor and non-motor functions in Parkinson's disease. More than a rehabilitation strategy, dance appears to be an optimal approach to promote functional outcomes as it combines physical, rhythmic, cognitive, emotional and social elements that could have a positive impact on multiple impairments in Parkinson's disease. The investigators believe that the notion of pleasure is crucial for rehabilitation, especially in people suffering from depression, and that it is often not taken into account in conventional rehabilitation strategies.

The goal of the present study is to confirm these preliminary results. This clinical study will run over two years, from January 2022 to January 2024, but an experimental session will last 4 months. The aim of this protocol is to better characterize the impact of dance on well-being, disease progression and possible neuronal reorganization in patients with Parkinson's disease. A better quality of life, a higher level of satisfaction and an improvement in functional status are expected in the experimental group.

During this study, three examinations will be carried out over 4 months. One at the start of the study, one at mid-term (after 8 weeks) and one at the end of the study. These evaluations will take place at the place of the dance lessons for the experimental group and within the university hospital for the control group.

Assessment will be done through different scales and questionnaires to assess well-being, satisfaction, feelings of happiness, functional status, cognitive functions and the correlation between functional and cognitive progress and neuronal activity.

This study is a "controlled and randomized" study that is to say that in a random manner, half of the participants will participate in weekly dance sessions lasting 60 minutes in addition to their conventional physiotherapy sessions while the control group will only receive conventional physiotherapy sessions during the first 4 months but will still benefit from dance sessions after the 4 months of evaluation.

Eligibility criteria: Inclusion Criteria:

* Patient with Parkinson's disease
* Hoehn \& Yahr Stadium \<3
* Signature of the written consent form

Exclusion Criteria:

* No cardiac or respiratory or neurological or rheumatological disease incompatible with the practice of a physical activity
* Has not had any surgery interfering with motor function in the past 6 months
* Has no cognitive impairment - MoCA \<26
* Does not present hearing problems that do not all

Primary outcomes:
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: 16 weeks
measure: Satisfaction and well-being visual analog scale
timeFrame: 16 weeks
Secondary outcomes:
measure: MDS-Unified Parkinson Disease Rating Scale part III (MDSUPDRS)
timeFrame: 16 weeks
measure: 10-m walk test (10MWT)
timeFrame: 16 weeks
measure: Time up and go
timeFrame: 16 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Esneux
country: Belgium
facility: Site Ourthe-Amblève - CHU de Liège
state: Liège
city: Tinlot
country: Belgium
facility: CNRF
state: Liège
city: Liège
country: Belgium
facility: CHU de Liège site Sart-Tilman
Study officials:
References: