Virtual Exercises in Patients With Parkinson's Disease.

EFFECTIVENESS OF VIRTUAL EXERCISES ON THE FUNCTIONAL EXERCISE CAPACITY, FATIGUE AND QUALITY OF LIFE IN PATIENTS WITH PARKINSON'S DISEASE: A RANDOMIZED CLINICAL TRIAL

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Virtual exercises

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Parana
    • Curitiba, Parana, Brazil
      • Associação Paranaense dos Portadores de Parkinsonismo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Faculdade Evangelica do Parana
• Investigators: Principal Investigator: Silvia Valderramas, PhD, Faculdade Evangélica do Paraná

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: December 27, 2013
• First Posted (Estimate): December 30, 2013

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Parkinson disease, Physical Therapy, Fatigue, Quality of Life
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: FEPAR - 04