Clinical trial NCT04422353: Video Dance Class and Unsupervised Physical Activity During Covid-19 Pandemic in People With Parkinson's Disease
Official title: The Impact of Video Dance Class and Unsupervised Physical Activity on Parkinson's People During the Covid-19 Pandemic: Interventional
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Parkinson Disease 10
Keywords: Functionality
movement disorders
rehabilitation
depressive symptoms
quality of life
cognition
self-isolation
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Aline Nogueira Haas
name: Flávia Gomes Martinez
First posted: 2020-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The aim of this study is to analyze the impact of video dance class and unsupervised physical activity on clinical-functional parameters, self-isolation and non-motors symptoms in people with Parkinson's disease during the Covid-19 pandemic.

Detailed description: Experimental Design: an interventional study. Search Location: Exercise Research Laboratory at the School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, and in the Movement Disorders Outpatient Clinic of the Hospital of Clinicals of Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil. Participants: 60 participants from the Dance, the Nordic Walking, and the Aquatic Jogging extension projects at Federal University of Rio Grande do Sul, both sexes, from 50 to 80 years old, diagnosed with idiopathic PD, will be separate in three groups: Video Dance Classes, in the unsupervised physical activity, and in the control group. Interventions: video dance class, unsupervised physical activity, and a control group. The video dance class program will have a frequency of two sessions per week and a duration of 30 minutes for 12 weeks. The unsupervised physical activity receives an unsupervised home exercise program with a frequency of two sessions per week and a duration of 30 minutes for 12 weeks during the Covid-19 pandemic.

The control group will be people with PD, engaged, before the Covid-19 pandemic, in the Dance, the Nordic Walk and the Aquatic Jogging extension projects at Federal University of Rio Grande do Sul but did not do any type of physical activity during the Covid-19 pandemic.

To evaluate the impacts of the activities during the Covid-19 pandemic, evaluations will be performed by telephone after 60 days of social distance and self-isolation. Outcomes: clinical-functional parameters and non-motor parameters. Data Analysis: Data will be described by average values and standard deviation values. The comparisons between groups will be performed using a Generalized Estimating Equations (GEE) analysis, adopting a level of significance (α) of 0.05. Expected Results: Participants who have remained committed with the video dance class or with the unsupervised physical activity during the Covid-19 pandemic expected to be less affected in the analyzed outcomes, especially in Quality of Life, when compared to the control group. In addition, it is expected that the research results could help to future developments in the scientific, technological, economic, social, and environmental fields.

Eligibility criteria: Inclusion Criteria:

* Volunteers
* aged over 50 years
* both sexes
* clinical diagnosis of idiopathic PD
* PD staging between 1 and 4 in Hoehn and Yahr Scale (H\&Y)
* Peoples with PD engaged, before the Covid-19 pandemic, in the Dance, the Nordic Walk and the Aquatic Jogging extension projects at Federal University of Rio Grande do Sul.

Exclusion Criteria:

* performing recent surgeries, deep brain stimulation (DBS - Deep Brain Stimulations);
* severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker;
* stroke or other associated neurological diseases; insanity;
* prostheses in the lower limbs;
* without ambulation conditions.

Primary outcomes:
measure: Quality of life (QoL)
timeFrame: Change from baseline at 12 weeks.
measure: Depressive symptoms - Geriatric Depression Scale - 15 item
timeFrame: Change from baseline at 12 weeks.
measure: Physical Activity - International Physical Activity Questionnaires (IPAQ)
timeFrame: Change from baseline at 12 weeks.
Secondary outcomes:
measure: Cognitive function - Montreal Cognitive Assessment by telephone
timeFrame: Change from baseline at 12 weeks.
measure: Falls - Falls Efficacy Scale - International
timeFrame: Change from baseline at 12 weeks.
measure: Functional lower extremity strength -Five Times Sit to Stand Test
timeFrame: Change from baseline at 12 weeks.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Leonardo A. Peyré-Tartaruga, PhD
role: STUDY_DIRECTOR
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