- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02622737
Study of the Effects of Three Exercise Programs in Parkinson's Disease (STEP)
Comparison of the Effects of Exercise by Functional Training, Stationary Bicycle and Exergame in Parkinson Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The original study goal was to recruit 210 subjects based on the assumption of a fall risk of 70% in the Bicycle group and 40% in either Exergaming or Functional Training groups, with 80% power and alpha=0.05.
GROUPS:
G1-Functional Training
The intensity was increased by progressive resistance with dumbbells, ankle weights, elastic bands and manual resistance.
- Gait with obstacles: To perform this exercise hula hoops, rubber cones, plastic sticks, wood steps and mattresses were used.
- Up and down stairs and ramp: The participant went up and down 3 steps and 1 ramp until completing 3 minutes.
- Sitting and standing exercises: To increase the difficulty level were used manual resistance, dumbbell and unstable bases (swiss ball).
- Side gear and shin guards: The participant performed side gait according to the physical therapist's commands.
- Balance exercise: The participant performed balance exercises in proprioceptive platforms: balance discs, jumping beds proprioceptive tables.
- Activities with ball: Kicking balls of different sizes and weights, alternating each foot.
- Step exercises: Going up and down steps with the right or left foot according to cognitive commands of the physical therapist.
- Foot tip exercises: The participant performed the exercise on flat and sloped surface with one or two feet maintaining sural triceps contraction for 5 seconds.
- Graded reaching exercises: The exercise was performed standing and sitting. Dual task activities were performed.
- Gait training: The participant walked around the gym following verbal commands to stop and change direction. Gait reeducation consisted of working scapular and pelvic girdle dissociation.
G2-Bicycle
Aerobic training on a stationary bicycle: The training intensity was 50% of maximum heart rate (adjusted for age - Karvonen formula) in the first week, increasing gradually to 75% in the eighth week.
First week: 50% of maximum heart rate. Second and Third weeks: 55% of maximum heart rate. Fourth and Fifth weeks: 65% of maximum heart rate. Sixth and Seventh weeks: 70% of maximum heart rate. Eighth week: 75% of maximum heart rate. The intensity was increased progressively by bike endurance (resistance) and speed.
G3-Exergaming
Physical components involved in Exergames (Virtual Reality Exposure Therapy): strength and muscular endurance, cardiorespiratory fitness, postural balance, executive function and emotional demands.
The participants did not use weights to perform the exercises in the Exergame Group. A physical therapist guided the participants to explore the correct posture and the articular range of motion using both tactile and assistive stimulus and/or verbal command during the games. Each mini-game lasts about 3-minutes, and to complete 30-minutes training, the same one or two mini-games were repeated in different levels of intensity and speed in each session. Mini-games of Kinect Advenctures! game:
- River Rush: One or two players must control the raft using their body, moving from side to side, and jumping in front of the Kinect sensor. Players must work as a team to earn as many points as possible.
- Reflex Ridge: One or two players can move freely on platforms (rollercoaster-like tracks), allowing them to dodge left and right, duck and jump over hazards as they spring forward. Jumping in place makes the platform move faster along its rail.
- 20,000 Leaks: The characters are positioned in a rectangular glass tank underwater, and each of the tank's four walls can crack and begin to leak water at any time. One or two players stand in front of the Kinect sensor and use their arms and legs - or any other body parts - to stop leaking water.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil, 41820000
- Centro de Referencia Estadual de Atencao a Saude do Idoso (CREASI)
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Functional Training
Functional exercise training program
|
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
|
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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of recurrent fallers (2 or more falls over the study period)
Time Frame: 6 months after completion of the exercise training
|
6 months after completion of the exercise training
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of recurrent fallers (2 or more falls over the study period)
Time Frame: 3 months
|
3 months
|
Number of falls
Time Frame: 6 months
|
6 months
|
6-Minute Walk Test (cardiovascular endurance)
Time Frame: 8 weeks
|
8 weeks
|
Get Up and Down Test
Time Frame: 8 weeks
|
8 weeks
|
10 meters test (gait speed)
Time Frame: 8 weeks
|
8 weeks
|
Photometry-measured posture
Time Frame: 8 weeks
|
8 weeks
|
Balance Evaluation Systems Test - BESTEST
Time Frame: 8 weeks
|
8 weeks
|
Frontal Assessment Battery - FAB
Time Frame: 8 weeks
|
8 weeks
|
Quality of life on the Parkinson's Disease Questionnaire-39 - PDQ39
Time Frame: 8 weeks
|
8 weeks
|
World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jamary Oliveira-Filho, MD, Federal University of Bahia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE # 41228415.5.0000.5662
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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