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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03193489
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : May 1, 2020
University Medical Center Groningen
Information provided by (Responsible Party):
Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital

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.

Condition or disease Intervention/treatment Phase
Follow up Parkinson Disease Rehabilitation Other: Follow-up Other: Post-treatment control Other: Control Parkinson group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A High-intensity Multi-component Agility Intervention in Parkinson's Patients: Two-year Follow-up
Actual Study Start Date : May 11, 2015
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Exercise therapy
Parkinson's group takes part in a treadmill treatment that takes place 3 times a week for 2 years.
Other: Follow-up
Other: Post-treatment control
After 3 weeks of intensive treatment, no special exercises are performed as a control.

Other: Control Parkinson group
No treatment.

Primary Outcome Measures :
  1. EQ5D-5L [ Time Frame: 0-5 scale (2 year-long, higher point is better) ]

  2. posturography [ Time Frame: mm (2 year-long, the smaller the mm the better the result) ]
    body sway, Objective measurement of holding instability

  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Parkinson's disease
  • Hoenh Yahr scale of 2-3
  • Instability problem

Exclusion Criteria:

  • Severe heart problems
  • Severe demeanor
  • Alcoholism
  • Drug problems
Additional Information:
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Responsible Party: Tollár József, Principal investigator, Somogy Megyei Kaposi Mór Teaching Hospital Identifier: NCT03193489    
Other Study ID Numbers: IKEB0013/2015
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital:
quality of life
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases