Study of the Effects of Three Exercise Programs in Parkinson's Disease (STEP)
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|ClinicalTrials.gov Identifier: NCT02622737|
Recruitment Status : Recruiting
First Posted : December 4, 2015
Last Update Posted : March 3, 2017
Introduction: Population aging is associated with increased prevalence of chronic diseases. Parkinson's disease (PD) is the second most common neurodegenerative disease in the world population, affecting motor function and functional independence progressively. The physiological aging promotes the gradual reduction of body weight, lung function, peripheral muscle strength, cardiopulmonary endurance and physical capacity, which increase the debilitating effects. Aging, when associated with PD, can induce loss of functionality, postural changes, further affecting the nutritional status, worsening the quality of life and functional independence of the individual. Although physical therapy is commonly applied with a variety of methodologies to PD patients, evidence for the effectiveness of these interventions is lacking.
Objective: The primary objective of the study is to compare the effects of Functional Training, Stationary Bike and Exergaming Exercises on proportion of fallers in elderly participants with PD. In addition, the secondary objectives are to compare the effects on cardiopulmonary endurance, posture, postural control, executive function, quality of life and functionality of individuals with PD.
Methodology: This is an interventional, randomized, blinded, longitudinal and prospective study. This research will be conducted in the State Reference Center for Health Care of the Elderly (CREASI). The sample will consist of 63 individuals with PD per group. The Experimental Group 1 will be submitted to Functional Training, the Experimental Group 2 with undergo training with Stationary Bike and the Experimental Group 3 will be submitted to exergame training using Xbox360 with KinectTM sensor. All the interventions will be performed three times per week, with 50 minutes per session, during 8 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Other: Functional training Device: Stationary bike Device: Exergaming||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of the Effects of Exercise by Functional Training, Stationary Bicycle and Exergame in Parkinson Disease|
|Actual Study Start Date :||March 2016|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Functional Training
Functional exercise training program
Other: Functional training
Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a functional training and 5 minutes of respiratory exercises.
Experimental: Stationary Bike
Stationary bike training program
Device: Stationary bike
Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a Stationary Bike exercise and 5 minutes of respiratory exercises.
Virtual Reality Exposure Therapy
Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a Virtual Reality exercise (performed by Xbox360 with KinectTM sensor) and 5 minutes of respiratory exercises.
Other Name: Virtual Reality Exposure Therapy
- Proportion of recurrent fallers (2 or more falls over the study period) [ Time Frame: 6 months after completion of the exercise training ]
- Proportion of recurrent fallers (2 or more falls over the study period) [ Time Frame: 3 months ]
- Number of falls [ Time Frame: 6 months ]
- 6-Minute Walk Test (cardiovascular endurance) [ Time Frame: 8 weeks ]
- Get Up and Down Test [ Time Frame: 8 weeks ]
- 10 meters test (gait speed) [ Time Frame: 8 weeks ]
- Photometry-measured posture [ Time Frame: 8 weeks ]
- Balance Evaluation Systems Test - BESTEST [ Time Frame: 8 weeks ]
- Frontal Assessment Battery - FAB [ Time Frame: 8 weeks ]
- Quality of life on the Parkinson's Disease Questionnaire-39 - PDQ39 [ Time Frame: 8 weeks ]
- World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0 [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622737
|Contact: Monica H Frank, MDfirstname.lastname@example.org|
|Centro de Referencia Estadual de Atencao a Saude do Idoso (CREASI)||Recruiting|
|Salvador, Bahia, Brazil, 41820000|
|Contact: Monica H Frank, MD +557132705750 email@example.com|
|Sub-Investigator: Daniel D Ferraz, PT|
|Sub-Investigator: Karen V Trippo, PT|
|Principal Investigator: Jamary Oliveira-Filho, MD|
|Principal Investigator:||Jamary Oliveira-Filho, MD||Federal University of Bahia|