Virtual Exercises in Patients With Parkinson's Disease.

NCT02023034 | Completed

• 1 other identifier: FEPAR - 04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease, Physical Therapy, Fatigue, Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reduction of Fatigue

  The subjects will be followed for a period of 90 days.

Other Outcomes (1)

• Improvement of Quality of life

  The subjects will be followed for a period of 90 days.

Study Arms (2)

Virtual exercises

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

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.

Control; Virtual exercises

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• will be selected for the study
• subjects with a clinical diagnosis of Parkinson's disease
• III H\&Y
• to 80 years
• both sexes
• with preserved cognitive stage (Mini Mental\> 24).

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculdade Evangelica do Parana: lead

Study Sites (1)

Associação Paranaense dos Portadores de Parkinsonismo

Curitiba, Paraná, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease; Fatigue

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Silvia Valderramas, PhD

  Faculdade Evangelica do Parana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Silvia Valderramas

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 30, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

BR (1)