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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02023034
Other study ID # FEPAR - 04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2013
Est. completion date February 2014

Study information

Verified date July 2019
Source Faculdade Evangelica do Parana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil Associação Paranaense dos Portadores de Parkinsonismo Curitiba Parana

Sponsors (1)

Lead Sponsor Collaborator
Faculdade Evangelica do Parana

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Improvement of Quality of life Assessed by the specific questionnaire for Parkinson's Disease, the PDQ 39. The subjects will be followed for a period of 90 days.
Primary 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. The subjects will be followed for a period of 90 days.
Secondary 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. The subjects will be followed for a period of 90 days.
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