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Study of the Effects of Three Exercise Programs in Parkinson's Disease (STEP)

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Functional training
Stationary bike
Exergaming
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Accidental Falls, Exercise therapy, Virtual Reality Exposure Therapy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Referencia Estadual de Atencao a Saude do Idoso (CREASI)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Functional Training

Stationary Bike

Exergaming

Arm Description

Functional exercise training program

Stationary bike training program

Virtual Reality Exposure Therapy

Outcomes

Primary Outcome Measures

Proportion of recurrent fallers (2 or more falls over the study period)

Secondary Outcome Measures

Proportion of recurrent fallers (2 or more falls over the study period)
Number of falls
6-Minute Walk Test (cardiovascular endurance)
Get Up and Down Test
10 meters test (gait speed)
Photometry-measured posture
Balance Evaluation Systems Test - BESTEST
Frontal Assessment Battery - FAB
Quality of life on the Parkinson's Disease Questionnaire-39 - PDQ39
World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0

Full Information

First Posted
November 26, 2015
Last Updated
October 8, 2019
Sponsor
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT02622737
Brief Title
Study of the Effects of Three Exercise Programs in Parkinson's Disease
Acronym
STEP
Official Title
Comparison of the Effects of Exercise by Functional Training, Stationary Bicycle and Exergame in Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
The recruitment site changed their admission policy to only more severely affected patients.
Study Start Date
December 14, 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, Accidental Falls, Exercise therapy, Virtual Reality Exposure Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional Training
Arm Type
Experimental
Arm Description
Functional exercise training program
Arm Title
Stationary Bike
Arm Type
Experimental
Arm Description
Stationary bike training program
Arm Title
Exergaming
Arm Type
Experimental
Arm Description
Virtual Reality Exposure Therapy
Intervention Type
Other
Intervention Name(s)
Functional training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Stationary bike
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Exergaming
Other Intervention Name(s)
Virtual Reality Exposure Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of recurrent fallers (2 or more falls over the study period)
Time Frame
6 months after completion of the exercise training
Secondary Outcome Measure Information:
Title
Proportion of recurrent fallers (2 or more falls over the study period)
Time Frame
3 months
Title
Number of falls
Time Frame
6 months
Title
6-Minute Walk Test (cardiovascular endurance)
Time Frame
8 weeks
Title
Get Up and Down Test
Time Frame
8 weeks
Title
10 meters test (gait speed)
Time Frame
8 weeks
Title
Photometry-measured posture
Time Frame
8 weeks
Title
Balance Evaluation Systems Test - BESTEST
Time Frame
8 weeks
Title
Frontal Assessment Battery - FAB
Time Frame
8 weeks
Title
Quality of life on the Parkinson's Disease Questionnaire-39 - PDQ39
Time Frame
8 weeks
Title
World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamary Oliveira-Filho, MD
Organizational Affiliation
Federal University of Bahia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Referencia Estadual de Atencao a Saude do Idoso (CREASI)
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41820000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29337023
Citation
Ferraz DD, Trippo KV, Duarte GP, Neto MG, Bernardes Santos KO, Filho JO. The Effects of Functional Training, Bicycle Exercise, and Exergaming on Walking Capacity of Elderly Patients With Parkinson Disease: A Pilot Randomized Controlled Single-blinded Trial. Arch Phys Med Rehabil. 2018 May;99(5):826-833. doi: 10.1016/j.apmr.2017.12.014. Epub 2018 Jan 11.
Results Reference
derived

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Study of the Effects of Three Exercise Programs in Parkinson's Disease

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