Parkinson Disease Clinical Trial
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
| 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 |
| Verified date | July 2019 |
| Source | Faculdade Evangelica do Parana |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Associação Paranaense dos Portadores de Parkinsonismo | Curitiba | Parana |
| Lead Sponsor | Collaborator |
|---|---|
| Faculdade Evangelica do Parana |
Brazil,
| 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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