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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
Sponsor:
Information provided by (Responsible Party):
Jamary Oliveira-Filho, Federal University of Bahia

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Experimental: Exergaming
Virtual Reality Exposure Therapy
Device: Exergaming
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




Primary Outcome Measures :
  1. Proportion of recurrent fallers (2 or more falls over the study period) [ Time Frame: 6 months after completion of the exercise training ]

Secondary Outcome Measures :
  1. Proportion of recurrent fallers (2 or more falls over the study period) [ Time Frame: 3 months ]
  2. Number of falls [ Time Frame: 6 months ]
  3. 6-Minute Walk Test (cardiovascular endurance) [ Time Frame: 8 weeks ]
  4. Get Up and Down Test [ Time Frame: 8 weeks ]
  5. 10 meters test (gait speed) [ Time Frame: 8 weeks ]
  6. Photometry-measured posture [ Time Frame: 8 weeks ]
  7. Balance Evaluation Systems Test - BESTEST [ Time Frame: 8 weeks ]
  8. Frontal Assessment Battery - FAB [ Time Frame: 8 weeks ]
  9. Quality of life on the Parkinson's Disease Questionnaire-39 - PDQ39 [ Time Frame: 8 weeks ]
  10. World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0 [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Regular use of medication for PD;
  • Age greater than or equal to 60 years;
  • Stage 2, 2.5 or 3 according to the modified Hoehn and Yahr classification;
  • Signed informed consent.

Exclusion Criteria:

  • neurodegenerative diseases other than Parkinson disease; dementia; muscle diseases that preclude the practice of physical activity; chronic uncontrolled disease (hypertension, diabetes mellitus, chronic pain); unstable cardiovascular disease (acute heart failure, myocardial recent infarction, unstable angina and uncontrolled arrhythmia); using alcohol and other toxic substances; contraindications for performing exercise according the criteria of the American College of Sports Medicine; to practice or have practiced physical exercise program in the last six months; to participate or have participated in regular resistance training (eg, 2-3 times per week) in the previous 12 months.

Information from the National Library of Medicine

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


Contacts
Contact: Monica H Frank, MD +557132705745 creasi.diretoria@outlook.com

Locations
Brazil
Centro de Referencia Estadual de Atencao a Saude do Idoso (CREASI) Recruiting
Salvador, Bahia, Brazil, 41820000
Contact: Monica H Frank, MD    +557132705750    creasi.diretoria@gmail.com   
Sub-Investigator: Daniel D Ferraz, PT         
Sub-Investigator: Karen V Trippo, PT         
Principal Investigator: Jamary Oliveira-Filho, MD         
Sponsors and Collaborators
Federal University of Bahia
Investigators
Principal Investigator: Jamary Oliveira-Filho, MD Federal University of Bahia

Responsible Party: Jamary Oliveira-Filho, Associate Professor, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT02622737     History of Changes
Other Study ID Numbers: CAAE # 41228415.5.0000.5662
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Jamary Oliveira-Filho, Federal University of Bahia:
Parkinson disease
Accidental Falls
Exercise therapy
Virtual Reality Exposure Therapy

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases