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

Primary Purpose

Parkinson Disease, Parkinson Disease 10

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Video Dance classes
Unsupervised physical activities
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Functionality, movement disorders, rehabilitation, depressive symptoms, quality of life, cognition, self-isolation

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal do Rio Grande do SulRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

video Dance classes

Unsupervised physical activities

control group

Arm Description

The dance program consists of dance lessons inspired by ForrΓ³ 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 forrΓ³ (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.

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.

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.

Outcomes

Primary Outcome Measures

Quality of life (QoL)
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 (100ΒΌmore health problems).
Depressive symptoms - Geriatric Depression Scale - 15 item
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.
Physical Activity - International Physical Activity Questionnaires (IPAQ)
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

Cognitive function - Montreal Cognitive Assessment by telephone
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.
Falls - Falls Efficacy Scale - International
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).
Functional lower extremity strength -Five Times Sit to Stand Test
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.

Full Information

First Posted
June 7, 2020
Last Updated
May 11, 2021
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Aline Nogueira Haas, FlΓ‘via Gomes Martinez
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1. Study Identification

Unique Protocol Identification Number
NCT04422353
Brief Title
Video Dance Class and Unsupervised Physical Activity During Covid-19 Pandemic in People With Parkinson's Disease
Acronym
PTT-Online
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Aline Nogueira Haas, FlΓ‘via Gomes Martinez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 (Ξ±) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Parkinson Disease 10
Keywords
Functionality, movement disorders, rehabilitation, depressive symptoms, quality of life, cognition, self-isolation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
video Dance classes
Arm Type
Experimental
Arm Description
The dance program consists of dance lessons inspired by ForrΓ³ 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 forrΓ³ (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.
Arm Title
Unsupervised physical activities
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Video Dance classes
Intervention Description
The dance program consists of dance lessons inspired by ForrΓ³ 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.
Intervention Type
Other
Intervention Name(s)
Unsupervised physical activities
Intervention Description
The classes will be held through a recorded video that must be played twice a week. Each video class lasts 30 minutes.
Primary Outcome Measure Information:
Title
Quality of life (QoL)
Description
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 (100ΒΌmore health problems).
Time Frame
Change from baseline at 12 weeks.
Title
Depressive symptoms - Geriatric Depression Scale - 15 item
Description
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.
Time Frame
Change from baseline at 12 weeks.
Title
Physical Activity - International Physical Activity Questionnaires (IPAQ)
Description
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.
Time Frame
Change from baseline at 12 weeks.
Secondary Outcome Measure Information:
Title
Cognitive function - Montreal Cognitive Assessment by telephone
Description
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.
Time Frame
Change from baseline at 12 weeks.
Title
Falls - Falls Efficacy Scale - International
Description
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).
Time Frame
Change from baseline at 12 weeks.
Title
Functional lower extremity strength -Five Times Sit to Stand Test
Description
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.
Time Frame
Change from baseline at 12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo A. PeyrΓ©-Tartaruga, PhD
Phone
+555133085818
Ext
5820
Email
leonardo.tartaruga@ufrgs.br
First Name & Middle Initial & Last Name or Official Title & Degree
Aline N. Haas, PhD
Phone
+555133085818
Ext
5820
Email
alinehaas02@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo A. PeyrΓ©-Tartaruga, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90690-200
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo A PeyrΓ©-Tartaruga, PhD
Phone
+555133085818
Ext
5820
Email
leonardo.tartaruga@ufrgs.br
First Name & Middle Initial & Last Name & Degree
Aline N. Haas, PhD
Phone
+5551999633496
Email
alinehaas02@hotmail.com
First Name & Middle Initial & Last Name & Degree
FlΓ‘via G. Martinez, PhD
First Name & Middle Initial & Last Name & Degree
Elren P. Monteiro, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Video Dance Class and Unsupervised Physical Activity During Covid-19 Pandemic in People With Parkinson's Disease

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