Effects of Intensity-matched Agility and Cycling Exercise Training on PD Patients' Clinical Symptoms, Posture, and Mobility

Not Applicable

Completed

• Conditions: Parkinson Disease; Rehabilitation; Balance; Motor Function
• Interventions: Other: Single-blind RTC of PD patients; Other: cycling

• Registration Number: NCT03193268
• Lead Sponsor: Somogy Megyei Kaposi Mór Teaching Hospital

Brief Summary

Determine the short-term and lasting effects of intensity-matched exercise programs on level 2-3 PD patients' clinical symptoms, postural control, and mobility.

Hypothesis

1. The inclusion of a Borg-scale/heart-rate matched active control group will allow us to test the idea that, in addition to a fitness element, the reflexive movements that chellenge PD patients' sensorimotor system will improve patients' clinical symptoms, posture, and mobility more than fitness training and that such lasting effects will be superior in the agility compared with the fitness-control group. This hypothesis emered from the idea that the favorable results in the currently under review paper may be in part due to a simple conditioning effect instead of a specific motor learning effect caused by the xbox training.

2. If feasible, i.e., if there is a lerge enough pool of patients to randomize, a balance training group will be also added to test the idea that the reflexive actions evoked by the agility program by xbox exergaming still produce superior adaptations vs. the balance group because xbox forces patients to rapidly and reflexively execute movements (respond to cues, prompts), while balance training allows patients to stop, go, stop, and go and disrupt the continous execution of linked movements. The disruptions of movement chains could arise from small losses of balance on the unstabel surfaces, need for patients to re-initiate every movement element of a sequence, planning each movement element. It is not clear yet how it woul be possible to match all three intervention groups on Borg/heart rate intensity.

Detailed Description

Agility: Xbox based high intensity program, as detailed in the submitted manuscript. Borg scale after after each exercise block is recorded. Heart rate continuosly measured. These data are used to set intensity in the fitness group.

Fitness: A stationary bicycle ergometer program that includes visual stimulation in the form of watching nature programs and movies to account for visual stimulus in Agility group. Mean heart rate and Borg scale readings from Agility group will form the target intensity.

Control: No-exercise, measurment-only control group.

Study Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-20
• Status Verified: 2017-07
• Study Start: 2017-10-15
• Primary Completion: 2017-11-21
• Study Completion: 2017-11-21
• Last Update Submitted: 2020-04-30
• Last Update Posted: 2020-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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

Exclusion Criteria

• Severe heart problems, severe demeanor, alcoholism, drug problems,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity agility group	Single-blind RTC of PD patients	Exercise therapy
Non-agility cycling group	cycling	Parkinson's Bicycle Group, which takes 1 hour of exercise every day for 5 weeks

Primary Outcome Measures

Name	Time	Method
Borg test	0-40 point (5 week-long, higher score is better)	Fatigue questionnaire
PDQ-39	0-39 scale (5week-long, higher score is better)	special Parkinson's Disease test - motor and no-motor function
EQ5D-5L	0-5 scale (5 weeks-long, the higher score is better)	Questionnaire
SPPB test (gait, balance, leg stregth)	0-12 scale (5 week-long, higher score is better)	Walking and balance testing

Trial Locations

Locations (1)

Somogy Megyei Kaposi Mór Teaching Hospital; 🇭🇺 Kaposvár, Somogy, Hungary