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

May 11, 2021 updated by: Leonardo A. Peyré-Tartaruga, Federal University of Rio Grande do Sul

The Impact of Video Dance Class and Unsupervised Physical Activity on Parkinson's People During the Covid-19 Pandemic: Interventional

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90690-200
        • Recruiting
        • Universidade Federal do Rio Grande do Sul
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Flávia G. Martinez, PhD
        • Sub-Investigator:
          • Elren P. Monteiro, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from baseline at 12 weeks.
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.
Change from baseline at 12 weeks.
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.
Change from baseline at 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at 12 weeks.
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).
Change from baseline at 12 weeks.
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.
Change from baseline at 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Aline Nogueira Haas
Flávia Gomes Martinez

Investigators

  • Study Director: Leonardo A. Peyré-Tartaruga, PhD, Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2020

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

December 30, 2024

Study Registration Dates

First Submitted

June 7, 2020

First Submitted That Met QC Criteria

June 7, 2020

First Posted (ACTUAL)

June 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTT-Parkinson/COVID19 (REGISTRY: PTT-Parkinson/COVID19)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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