Effects of Intensity-matched Agility and Cycling Exercise Training on PD Patients' Clinical Symptoms, Posture, and Mobility
Primary Purpose
Parkinson Disease, Balance, Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Single-blind RTC of PD patients
cycling
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring sensorimotor training, quality of life, posture
Eligibility Criteria
Inclusion Criteria:
- Parkinson's disease,
- Hoenh Yahr scale of 2-3,
- instability problem,
Exclusion Criteria:
• Severe heart problems, severe demeanor, alcoholism, drug problems,
Sites / Locations
- Somogy Megyei Kaposi Mór Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
High intensity agility group
Non-agility cycling group
No-exercise control group
Arm Description
Exercise therapy
Parkinson's Bicycle Group, which takes 1 hour of exercise every day for 5 weeks
Control Parkinson's disease control group thad will not receive exercise treatment
Outcomes
Primary Outcome Measures
EQ5D-5L
Questionnaire
Borg test
Fatigue questionnaire
PDQ-39
special Parkinson's Disease test - motor and no-motor function
SPPB test (gait, balance, leg stregth)
Walking and balance testing
Secondary Outcome Measures
Full Information
NCT ID
NCT03193268
First Posted
June 1, 2017
Last Updated
April 30, 2020
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03193268
Brief Title
Effects of Intensity-matched Agility and Cycling Exercise Training on PD Patients' Clinical Symptoms, Posture, and Mobility
Official Title
Effects of Intensity-matched Agility and Cycling Exercise Training on PD Patients' Clinical Symptoms, Posture, and Mobility
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
November 21, 2017 (Actual)
Study Completion Date
November 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Determine the short-term and lasting effects of intensity-matched exercise programs on level 2-3 PD patients' clinical symptoms, postural control, and mobility.
Hypothesis
The inclusion of a Borg-scale/heart-rate matched active control group will allow us to test the idea that, in addition to a fitness element, the reflexive movements that chellenge PD patients' sensorimotor system will improve patients' clinical symptoms, posture, and mobility more than fitness training and that such lasting effects will be superior in the agility compared with the fitness-control group. This hypothesis emered from the idea that the favorable results in the currently under review paper may be in part due to a simple conditioning effect instead of a specific motor learning effect caused by the xbox training.
If feasible, i.e., if there is a lerge enough pool of patients to randomize, a balance training group will be also added to test the idea that the reflexive actions evoked by the agility program by xbox exergaming still produce superior adaptations vs. the balance group because xbox forces patients to rapidly and reflexively execute movements (respond to cues, prompts), while balance training allows patients to stop, go, stop, and go and disrupt the continous execution of linked movements. The disruptions of movement chains could arise from small losses of balance on the unstabel surfaces, need for patients to re-initiate every movement element of a sequence, planning each movement element. It is not clear yet how it woul be possible to match all three intervention groups on Borg/heart rate intensity.
Detailed Description
Agility: Xbox based high intensity program, as detailed in the submitted manuscript. Borg scale after after each exercise block is recorded. Heart rate continuosly measured. These data are used to set intensity in the fitness group.
Fitness: A stationary bicycle ergometer program that includes visual stimulation in the form of watching nature programs and movies to account for visual stimulus in Agility group. Mean heart rate and Borg scale readings from Agility group will form the target intensity.
Control: No-exercise, measurment-only control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Balance, Rehabilitation, Motor Function
Keywords
sensorimotor training, quality of life, posture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High intensity agility group
Arm Type
Experimental
Arm Description
Exercise therapy
Arm Title
Non-agility cycling group
Arm Type
Experimental
Arm Description
Parkinson's Bicycle Group, which takes 1 hour of exercise every day for 5 weeks
Arm Title
No-exercise control group
Arm Type
No Intervention
Arm Description
Control Parkinson's disease control group thad will not receive exercise treatment
Intervention Type
Other
Intervention Name(s)
Single-blind RTC of PD patients
Intervention Description
The groups participate in observation for 5 weeks. Two groups take part in a motion therapy over the 5-week period.
Intervention Type
Other
Intervention Name(s)
cycling
Intervention Description
Patients must undergo a daily exercise cycle of 1 hour during the intervention
Primary Outcome Measure Information:
Title
EQ5D-5L
Description
Questionnaire
Time Frame
0-5 scale (5 weeks-long, the higher score is better)
Title
Borg test
Description
Fatigue questionnaire
Time Frame
0-40 point (5 week-long, higher score is better)
Title
PDQ-39
Description
special Parkinson's Disease test - motor and no-motor function
Time Frame
0-39 scale (5week-long, higher score is better)
Title
SPPB test (gait, balance, leg stregth)
Description
Walking and balance testing
Time Frame
0-12 scale (5 week-long, higher score is better)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Parkinson's disease,
Hoenh Yahr scale of 2-3,
instability problem,
Exclusion Criteria:
• Severe heart problems, severe demeanor, alcoholism, drug problems,
Facility Information:
Facility Name
Somogy Megyei Kaposi Mór Teaching Hospital
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/
Description
Description Related Info
Learn more about this trial
Effects of Intensity-matched Agility and Cycling Exercise Training on PD Patients' Clinical Symptoms, Posture, and Mobility
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