Two-year Follow-up to High-intensity Multi-component Agility Intervention That Improves Clinical and Motor Symptoms of Parkinson's Disease

NCT03193489 | Completed DMC

• 1 other identifier: IKEB0013/2015
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Follow up; Parkinson Disease; Rehabilitation

Keywords

Balance; Posturograpy; quality of life

Outcome Measures

Primary Outcomes (3)

• EQ5D-5L

  Questionnaire

  0-5 scale (2 year-long, higher point is better)

• posturography

  body sway, Objective measurement of holding instability

  mm (2 year-long, the smaller the mm the better the result)

• Timed up and Go test

  Measuring the speed of walking

  sec (2 year-long, the less time you take the test, the better the result )

Study Arms (1)

Exercise therapy

EXPERIMENTAL

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; Other: Control Parkinson group

Interventions

Follow-up OTHER

Exercise therapy

Post-treatment control OTHER

After 3 weeks of intensive treatment, no special exercises are performed as a control.

Exercise therapy

Control Parkinson group OTHER

No treatment.

Exercise therapy

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe heart problems
• Severe demeanor
• Alcoholism
• Drug problems

Sponsors & Collaborators

• Somogy Megyei Kaposi Mór Teaching Hospital: lead
• University Medical Center Groningen: collaborator

Related Links

• Description Related Info

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 20, 2017
• Study Start: May 11, 2015
• Primary Completion: May 31, 2017
• Study Completion: June 30, 2017
• Last Updated: May 1, 2020

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share