Clinical trial NCT03189680: Agility Training in Parkinson's Disease
Official title: A High-Intensity Multi-Component Agility Intervention Improves Parkinson's Patients' Clinical and Motor Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: sensorimotor training
exergaming
posture
quality of life
Lead sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
First posted: 2017-06-16
Enrollment: 3
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The single-arm, 3-week-long intervention, administered daily, targeted postural instability and mobility using at-limit intensity sensorimotor and visuomotor agility training (n = 35, 17 males) conceptualized but seldom implemented previously. Each of the 15 training sessions lasted 60 minutes. Patients performed each exercise under increasingly difficult conditions and speed according to principles of periodization. All patients kept an exercise log detailing the positive and negative effects of the intervention on clinical and motor symptoms. The logs and attendance were checked daily. The no-intervention control, consisting of PD patients (n = 20, 12 males) received unsupervised standard care, consisting of the prescribed medications and daily, unsupervised 30 minutes of exercises at home.
Primary purpose: TREATMENT

Brief summary: To determine the effects of an unusually highly intensity and individualized sensorimotor and visuomotor agility exercise program on non-demented PD patients' clinical symptoms, mobility, and postural stability.

Detailed description: Design: Intervention study

Setting: Outpatient rehabilitation center

Participants: 55 Parkinson's disease (PD) patients completed the trial and 42 serves as comparison healthy controls

Intervention: An initial screening established specific dysfunctions of PD patients with Hoehn-Yahr stage 2-3 who were then randomly assigned to standard care (n = 20) or standard care plus at-limit intensity, individualized agility program (15 sessions, 3 weeks, n = 35).

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 the picture parkinson's disease based on MDS-UPDRS M-EDL, Beck depression score, PDQ-39, EQ5D VAS, Schwab \& England scale. 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-demented, stage 2-3 PD patients' clinical symptoms, mobility, and postural stability by functionally meaningful margins.

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

Primary outcomes:
measure: EQ5D-5L
timeFrame: 0-5 scale (3 week-long, higher number is better)
Secondary outcomes:
Other outcomes:
Locations:
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Teaching Hospital
state: Somogy
Study officials:
References:
citation: Tollar J, Nagy F, Kovacs N, Hortobagyi T. Two-Year Agility Maintenance Training Slows the Progression of Parkinsonian Symptoms. Med Sci Sports Exerc. 2019 Feb;51(2):237-245. doi: 10.1249/MSS.0000000000001793.