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OpenTrials
Completed

NCT Number: NCT02023034

Virtual Exercises in Patients With Parkinson's Disease.

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Associação Paranaense dos Portadores de Parkinsonismo

Curitiba, Paraná, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual exercises

Other

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Faculdade Evangelica do Parana

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 30, 2013
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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