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Virtual Exercises in Patients With Parkinson's Disease.

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ClinicalTrials.gov Identifier: NCT02023034
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Silvia Valderramas, Faculdade Evangelica do Parana

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: Virtual exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual 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, the period instrument used was the video game with the Nintendo ® Wii Balance Board ® platform.
Other: Virtual exercises
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.

Sham Comparator: Control
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.
Other: Virtual exercises
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 Measures :
  1. Improvement of functional exercise capacity [ Time Frame: The subjects will be followed for a period of 90 days. ]
    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 :
  1. Reduction of Fatigue [ Time Frame: The subjects will be followed for a period of 90 days. ]
    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.


Other Outcome Measures:
  1. Improvement of Quality of life [ Time Frame: The subjects will be followed for a period of 90 days. ]
    Assessed by the specific questionnaire for Parkinson's Disease, the PDQ 39.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02023034


Locations
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Brazil
Associação Paranaense dos Portadores de Parkinsonismo
Curitiba, Parana, Brazil
Sponsors and Collaborators
Faculdade Evangelica do Parana
Investigators
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Principal Investigator: Silvia Valderramas, PhD Faculdade Evangelica do Parana

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Responsible Party: Silvia Valderramas, Faculdade Evangelica do Parana
ClinicalTrials.gov Identifier: NCT02023034     History of Changes
Other Study ID Numbers: FEPAR - 04
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

Keywords provided by Silvia Valderramas, Faculdade Evangelica do Parana:
Parkinson disease, Physical Therapy, Fatigue, Quality of Life

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