NCT05175365

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).

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
68

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

December 14, 2021

Last Update Submit

July 27, 2022

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • Parkinson's Disease Questionnaire (PDQ-39)

    This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. It also assesses the impact of Parkinson's on specific dimensions of functioning and well-being. Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.

    16 weeks

  • Satisfaction and well-being visual analog scale

    Patients will have to rate their feeling of satisfaction and well-being on a scale ranging from 0 (worst/lowest state of satisfaction and happiness) to 100 (highest state of satisfaction and happiness).

    16 weeks

Secondary Outcomes (4)

  • MDS-Unified Parkinson Disease Rating Scale part III (MDSUPDRS)

    16 weeks

  • 10-m walk test (10MWT)

    16 weeks

  • Time up and go

    16 weeks

  • Montreal Cognitive Assessment (MoCA)

    16 weeks

Study Arms (2)

Dance

EXPERIMENTAL

Patients allocated to this group will attend dance classes for patients with Parkinson's disease given once a week over a 4-month period for a total of 16 dance sessions.

Behavioral: Dance

Control

NO INTERVENTION

The control group will receive its rehabilitation care.

Interventions

DanceBEHAVIORAL

Each session consists of a 60-minute dance class taught by a professional dancer. Dance classes begin with a seated warm-up with various coordination, rhythm, range of motion, memorization and coordination exercises. The level of difficulty of the exercises increases as the sessions progress. Balance is also an important part of training as well as the feeling of being part of a group, of interacting with each other. The hour ends with stretching in a sitting position.

Dance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Site Ourthe-Amblève - CHU de Liège

Esneux, Liège, 4130, Belgium

RECRUITING

CNRF

Tinlot, Liège, 4557, Belgium

RECRUITING

CHU de Liège site Sart-Tilman

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Helena Cassol, PhD

CONTACT

+32475474128hcassol@chuliege.be

Olivier Bouquiaux, MD

CONTACT

+32495501576olivier.bouquiaux@chuliege.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 3, 2022

Study Start

April 1, 2022

Primary Completion

January 1, 2024

Study Completion

January 1, 2025

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

BE(3)