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Virtual Exercises in Patients With Parkinson's Disease.

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Virtual exercises
Sponsored by
Faculdade Evangelica do Parana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Physical Therapy, Fatigue, Quality of Life

Eligibility Criteria

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

Inclusion Criteria:

  • will be selected for the study
  • subjects with a clinical diagnosis of Parkinson's disease
  • 0-III H&Y
  • 40 to 80 years
  • both sexes
  • with preserved cognitive stage (Mini Mental> 24).

Exclusion Criteria:

  • will be excluded subjects who have some acute pain or associated diseases
  • such as severe or unstable heart disease
  • visual disturbances
  • using some march auxiliary device, which compromise the 6MWT and exercise protocol

Sites / Locations

  • Associação Paranaense dos Portadores de Parkinsonismo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Virtual exercises

Control

Arm Description

All patients underwent 12 sessions, twice a week for a period of 06 weeks. The exercises were performed in the "on" dopaminergic medication, supervised by the researchers, the period instrument used was the video game with the Nintendo ® Wii Balance Board ® platform.

Traditional exercises. All patients underwent 12 sessions, twice a week for a period of 06 weeks. The exercises were performed in the "on" dopaminergic medication, supervised by the researchers.

Outcomes

Primary Outcome Measures

Improvement of functional exercise capacity
Assessed by the 6-minute walk test (6MWT), according to the guidelines of the American Thoracic Society, which is based on the evaluation of the maximum distance traveled by the patient for six minutes, expressed in meters.

Secondary Outcome Measures

Reduction of Fatigue
Assessed by the Fatigue Severity Scale, which consists of a questionnaire that assesses the impact of fatigue-related activities of daily living, rating ranges from 1 to 7 where 1 indicates little tired and 7, very tired.

Full Information

First Posted
December 23, 2013
Last Updated
July 30, 2019
Sponsor
Faculdade Evangelica do Parana
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1. Study Identification

Unique Protocol Identification Number
NCT02023034
Brief Title
Virtual Exercises in Patients With Parkinson's Disease.
Official Title
EFFECTIVENESS OF VIRTUAL EXERCISES ON THE FUNCTIONAL EXERCISE CAPACITY, FATIGUE AND QUALITY OF LIFE IN PATIENTS WITH PARKINSON'S DISEASE: A RANDOMIZED CLINICAL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade Evangelica do Parana

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction: Although the motor changes are well determined in Parkinson's disease (PD), few studies describe the effects the virtual exercises on the clinical and functional outcomes in this disease. Objectives: To analyze the effectiveness of virtual exercises on functional exercise capacity, fatigue and quality of life in patients with PD. Methods: 20 subjects, 60 years old will be included, who will be randomized into 2 groups: group of virtual exercises associated with conventional exercises (n = 10) and control group with conventional exercise group (n = 10). The following variables are evaluated: functional exercise through walking test in 6 minutes, fatigue by the Fatigue Severity Scale and Quality of Life through Quality of Life Questionnaire-PDQ-39.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Physical Therapy, Fatigue, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual exercises
Arm Type
Experimental
Arm Description
All patients underwent 12 sessions, twice a week for a period of 06 weeks. The exercises were performed in the "on" dopaminergic medication, supervised by the researchers, the period instrument used was the video game with the Nintendo ® Wii Balance Board ® platform.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Traditional exercises. All patients underwent 12 sessions, twice a week for a period of 06 weeks. The exercises were performed in the "on" dopaminergic medication, supervised by the researchers.
Intervention Type
Other
Intervention Name(s)
Virtual exercises
Intervention Description
The exercises will be performed with the Nintendo ® Wii Balance Board ® platform, and consist in: 1) Table Tilt; 2) Obstacle Course; 3) Tilt City; 4) Basic step; 5) Penguin; 6) Heading Soccer; 7) Basic Run. All patients underwent 12 sessions, twice a week for a period of 06 weeks.
Primary Outcome Measure Information:
Title
Improvement of functional exercise capacity
Description
Assessed by the 6-minute walk test (6MWT), according to the guidelines of the American Thoracic Society, which is based on the evaluation of the maximum distance traveled by the patient for six minutes, expressed in meters.
Time Frame
The subjects will be followed for a period of 90 days.
Secondary Outcome Measure Information:
Title
Reduction of Fatigue
Description
Assessed by the Fatigue Severity Scale, which consists of a questionnaire that assesses the impact of fatigue-related activities of daily living, rating ranges from 1 to 7 where 1 indicates little tired and 7, very tired.
Time Frame
The subjects will be followed for a period of 90 days.
Other Pre-specified Outcome Measures:
Title
Improvement of Quality of life
Description
Assessed by the specific questionnaire for Parkinson's Disease, the PDQ 39.
Time Frame
The subjects will be followed for a period of 90 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: will be selected for the study subjects with a clinical diagnosis of Parkinson's disease 0-III H&Y 40 to 80 years both sexes with preserved cognitive stage (Mini Mental> 24). Exclusion Criteria: will be excluded subjects who have some acute pain or associated diseases such as severe or unstable heart disease visual disturbances using some march auxiliary device, which compromise the 6MWT and exercise protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Valderramas, PhD
Organizational Affiliation
Faculdade Evangelica do Parana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Associação Paranaense dos Portadores de Parkinsonismo
City
Curitiba
State/Province
Parana
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Virtual Exercises in Patients With Parkinson's Disease.

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