Clinical trial NCT05910216: Online Dance Versus Therapeutic Exercise for Parkinson Disease.
Official title: Online Dance Versus Online Therapeutic Exercise on Quality of Life - A Protocol for a Randomized Controlled Trial Investigating Social Telerehabilitation Efficacy in Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Dance
Physiotherapy
Telehealth
Telerehabilitation
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two groups
Primary purpose: TREATMENT

Brief summary: This is a randomized clinical trial in an online format, which will only include people with PD randomly divided into two groups:

Group 1 - Social Telerehabilitation with Dance and Music Group 2 - Social Telerehabilitation with Multimodal Therapeutic Exercise and Music


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of idiopathic PD according to the clinical criteria of the London Brain Bank Criteria (2006);
* Age between 40-90 years;
* A minimum score of 18 in the Montreal Cognitive Assessment;
* Drug therapy/exercise stable for at least four weeks before the study starts;
* Agreement to participate in the study according to the Informed Consent Form.

Exclusion Criteria:

* Auditory and/or visual disturbances that compromise understanding simple commands;
* Access to the internet and a device to access online classes;
* A house member and/or caregiver at home for supervision during the entire experiment, including evaluations and interventions. For patients scoring less than 2.5 points on the modified Hoehn and Yahr Scale (indicating mild disease impairment, independence in daily living activities, and no risk of falls), the requirement for household member supervision may be waived.

Primary outcomes:
measure: Assessment of Quality of life
timeFrame: Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)
measure: Assessment of Well-being
timeFrame: Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)
Secondary outcomes:
measure: Assessment of Motor symptoms severity
timeFrame: Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)
measure: Assessment of Functional lower extremity strength
timeFrame: Change from Pre to Post treatment (12 weeks)
measure: Assessment of Symptoms of Anxiety
timeFrame: Change from Pre to Post treatment (12 weeks)
measure: Assessment of Attention and Memory Recognition
timeFrame: Change from Pre to Post treatment (12 weeks)
measure: Feasibility (self-perceptions)
timeFrame: Change from Pre to Post treatment (12 weeks)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Aline
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Aline Pagnussat, PhD
role: PRINCIPAL_INVESTIGATOR
References: