NCT Number: NCT03193489
Two-year Follow-up to High-intensity Multi-component Agility Intervention That Improves Clinical and Motor Symptoms of Parkinson's Disease
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.
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Notify MeKey information
Conditions
Age range
55 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Parkinson's disease
- Hoenh Yahr scale of 2-3
- Instability problem
Exclusion criteria
- Severe heart problems
- Severe demeanor
- Alcoholism
- Drug problems
Treatment and study plan
Post-treatment control
OtherAfter 3 weeks of intensive treatment, no special exercises are performed as a control.
Control Parkinson group
OtherNo treatment.
Primary outcomes
-
EQ5D-5L
Time frame: 0-5 scale (2 year-long, higher point is better)
Questionnaire
-
posturography
Time frame: mm (2 year-long, the smaller the mm the better the result)
body sway, Objective measurement of holding instability
-
Timed up and Go test
Time frame: sec (2 year-long, the less time you take the test, the better the result )
Measuring the speed of walking
Sponsors and collaborators
Lead sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
Other
Collaborators
- University Medical Center Groningen
Registry information
Official study title
A High-intensity Multi-component Agility Intervention in Parkinson's Patients: Two-year Follow-up
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jun 20, 2017
- Registry last updated
- May 1, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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