Two-year Follow-up to High-intensity Multi-component Agility Intervention That Improves Clinical and Motor Symptoms of Parkinson's Disease
Primary Purpose
Follow up, Parkinson Disease, Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Follow-up
Post-treatment control
Control Parkinson group
Sponsored by
About this trial
This is an interventional treatment trial for Follow up focused on measuring Balance, Posturograpy, quality of life
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
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise therapy
Arm Description
Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years.
Outcomes
Primary Outcome Measures
EQ5D-5L
Questionnaire
posturography
body sway, Objective measurement of holding instability
Timed up and Go test
Measuring the speed of walking
Secondary Outcome Measures
Full Information
NCT ID
NCT03193489
First Posted
June 1, 2017
Last Updated
April 29, 2020
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
Collaborators
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT03193489
Brief Title
Two-year Follow-up to High-intensity Multi-component Agility Intervention That Improves Clinical and Motor Symptoms of Parkinson's Disease
Official Title
A High-intensity Multi-component Agility Intervention in Parkinson's Patients: Two-year Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 11, 2015 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
Collaborators
University Medical Center Groningen
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
Individualization of exercise is recommended but rarely performed in patients with Parkinson's disease (PD).
Unusually High Intensity and Individual Sensor Motor with Visuomotor Mobility Trainer The clinical symptoms, mobility and posture of PD patients. After 3 weeks of intensive treatment, treated patients and the control group were subjected to a two-year observation.
Objectives: The effect of the unusually highly intense and strictly individualized sensomotor and visuomotor agility program was determined for the clinical symptoms, mobility and stability of non-demented PD patients with a two-year follow-up. Detection and comparison of results of patients undergoing biphasic maintenance with the results of intensively treated patients and the control group.
Patients were recalled every 3 months after the first intensive examination and one year after a one-year control. The results of the active group were continuously compared with the results of the passive and control groups, thus determining the effectiveness of our treatment and the deterioration of the other groups in life-quality.
The treated groups will be divided into two. One Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years. The other group does not undergo a special series of exercises after 3 weeks of intensive therapy.
Main outcome measures: Movement disorder Society Unified Parkinson Disease Rating Scale, Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD symptoms.
In group time, repeated measurements of variance analysis were compared to MDS-UPDRS M-EDL, Beck Depression Score, PDQ-39, EQ5D VAS, Schwab & England Scale for Parkinson's Disease. The TUG test and 12 static posturographic measurements are compared and compared to the healthy group as a standard.
An at-limit and individualized sensorimotor and visuomotor agility exercise program vs. standard care, will improve non-demeted, stage 2-3 PD patient's clinical symptoms, mobility, and postural stability by functionally meaningful margins. As a long-term solution, a follow-up treatment can slow down the progression of clinical symtoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follow up, Parkinson Disease, Rehabilitation
Keywords
Balance, Posturograpy, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise therapy
Arm Type
Experimental
Arm Description
Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years.
Intervention Type
Other
Intervention Name(s)
Follow-up
Intervention Type
Other
Intervention Name(s)
Post-treatment control
Intervention Description
After 3 weeks of intensive treatment, no special exercises are performed as a control.
Intervention Type
Other
Intervention Name(s)
Control Parkinson group
Intervention Description
No treatment.
Primary Outcome Measure Information:
Title
EQ5D-5L
Description
Questionnaire
Time Frame
0-5 scale (2 year-long, higher point is better)
Title
posturography
Description
body sway, Objective measurement of holding instability
Time Frame
mm (2 year-long, the smaller the mm the better the result)
Title
Timed up and Go test
Description
Measuring the speed of walking
Time Frame
sec (2 year-long, the less time you take the test, the better the result )
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
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/
Description
Description Related Info
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Two-year Follow-up to High-intensity Multi-component Agility Intervention That Improves Clinical and Motor Symptoms of Parkinson's Disease
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