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Video Dance Class and Unsupervised Physical Activity During Covid-19 Pandemic in People With Parkinson's Disease (PTT-Online)

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ClinicalTrials.gov Identifier: NCT04422353
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Aline Nogueira Haas
Flávia Gomes Martinez
Elren Passos Monteiro
Information provided by (Responsible Party):
Leonardo A. Peyré-Tartaruga, Federal University of Rio Grande do Sul

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Parkinson Disease 10 Other: Video Dance classes Other: Unsupervised physical activities Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Video Dance Class and Unsupervised Physical Activity on Parkinson's People During the Covid-19 Pandemic: Interventional
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: video Dance classes

The dance program consists of dance lessons inspired by Forró rhythm and Samba rhythm.

Classes will be divided into four stages: Joint warm-up and stretching on the chairs; strengthening, balance, and rhythm exercises with the support of the chair; exercises inspired by the samba and forró (Brazilian ballroom dance) basic steps; and Final cool down. The classes will be held through a recorded video that must be played twice a week. Each video class lasts 30 minutes.

The video Dance classes will happen in the period of self-isolation and social distance during the Covid-19 pandemic.

Other: Video Dance classes
The dance program consists of dance lessons inspired by Forró rhythm and Samba rhythm. The classes will be held through a recorded video that must be played twice a week. Each video class lasts 30 minutes.

Active Comparator: Unsupervised physical activities
The unsupervised physical activity programs will happen in the period of self-isolation and social distance during the Covid-19 pandemic. The classes will be held through a recorded video that must be played twice a week. Each video class lasts 30 minutes.
Other: Unsupervised physical activities
The classes will be held through a recorded video that must be played twice a week. Each video class lasts 30 minutes.

No Intervention: control group
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.



Primary Outcome Measures :
  1. Quality of life (QoL) [ Time Frame: Change from baseline at 12 weeks. ]
    The quality of life (QoL) will be measured by the Parkinson's Disease Quality of life (PDQ-8). PDQ-8 is a reduced version of a specific health status questionnaire comprising 39 items, with 8 items. Respondents are requested to affirm one of five ordered response categories according to how often, due to their PD, they have experienced the problem defined by each item. Each item is grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 (100¼more health problems).

  2. Depressive symptoms - Geriatric Depression Scale - 15 item [ Time Frame: Change from baseline at 12 weeks. ]
    This outcome will be measure for the Geriatric Depression Scale - 15 item. The scale consists of 15 dichotomous questions in which participants are asked to answer yes or no about how they felt over the past week (for instance, "Do the patient feel that their life is empty?," Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms.

  3. Physical Activity - International Physical Activity Questionnaires (IPAQ) [ Time Frame: Change from baseline at 12 weeks. ]
    This outcome will be measure for the International Physical Activity Questionnaires (IPAQ). The IPAQ comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.


Secondary Outcome Measures :
  1. Cognitive function - Montreal Cognitive Assessment by telephone [ Time Frame: Change from baseline at 12 weeks. ]
    Montreal Cognitive Assessment (MoCA) is a brief screening tool for mild cognitive impairment. This evaluation accesses different cognitive domains and investigates the individual's abilities in the following areas: attention and concentration, executive functions, memory, language, visuoconstructive skills, conceptualization, calculation, and orientation. The total score of the MoCA is 30 points, with a score of 26, or more, considered normal and less than 26 is considered a cognitive impairment.

  2. Falls - Falls Efficacy Scale - International [ Time Frame: Change from baseline at 12 weeks. ]
    This outcome will be measure for the Falls - Falls Efficacy Scale - International (FES-I). FES-I can be administered as self-completion questionnaires, or administered verbally as part of a research interview or clinical assessment. To calculate the FES-I score when all items are completed, simply add the scores for each item together to give a total that ranges as follows: minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).

  3. Functional lower extremity strength -Five Times Sit to Stand Test [ Time Frame: Change from baseline at 12 weeks. ]
    The Five Times Sit to Stand Test measures one aspect of transfer skill. This test quantifies functional lower extremity strength and identifies movement strategies a people use to complete the transitional movement.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422353


Contacts
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Contact: Leonardo A. Peyré-Tartaruga, PhD +555133085818 ext 5820 leonardo.tartaruga@ufrgs.br
Contact: Aline N. Haas, PhD +555133085818 ext 5820 alinehaas02@hotmail.com

Locations
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Brazil
Universidade Federal do Rio Grande do Sul Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90690-200
Contact: Leonardo A Peyré-Tartaruga, PhD    +555133085818 ext 5820    leonardo.tartaruga@ufrgs.br   
Contact: Aline N. Haas, PhD    +5551999633496    alinehaas02@hotmail.com   
Sub-Investigator: Flávia G. Martinez, PhD         
Sub-Investigator: Elren P. Monteiro, PhD         
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Aline Nogueira Haas
Flávia Gomes Martinez
Elren Passos Monteiro
Investigators
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Study Director: Leonardo A. Peyré-Tartaruga, PhD Federal University of Rio Grande do Sul
Publications of Results:
Other Publications:

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Responsible Party: Leonardo A. Peyré-Tartaruga, Adjunct Professor, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT04422353    
Other Study ID Numbers: PTT-Parkinson/COVID19
PTT-Parkinson/COVID19 ( Registry Identifier: PTT-Parkinson/COVID19 )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Leonardo A. Peyré-Tartaruga, Federal University of Rio Grande do Sul:
Functionality
movement disorders
rehabilitation
depressive symptoms
quality of life
cognition
self-isolation
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases