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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Rehabilitation; Motor Function; Balance
• Intervention / Treatment: Other: Single-blind RTC of PD patients; Other: cycling

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Somogy
    • Kaposvár, Somogy, Hungary, 7400
      • Somogy Megyei Kaposi Mór Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High intensity agility group; Exercise therapy	Other: Single-blind RTC of PD patients; The groups participate in observation for 5 weeks. Two groups take part in a motion therapy over the 5-week period.
Experimental: Non-agility cycling group; Parkinson's Bicycle Group, which takes 1 hour of exercise every day for 5 weeks	Other: cycling; Patients must undergo a daily exercise cycle of 1 hour during the intervention
No Intervention: No-exercise control group; Control Parkinson's disease control group thad will not receive exercise treatment

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Somogy Megyei Kaposi Mór Teaching Hospital

Publications and helpful links

Helpful Links

• Description Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Actual): November 21, 2017
• Study Completion (Actual): November 21, 2017

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: quality of life; posture; sensorimotor training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: IKEB0014/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No