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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03193268
• Other study ID #: IKEB0014/2015
• Status: Completed
• Phase: N/A
• Start date: October 15, 2017
• Est. completion date: November 21, 2017

Study information

• Verified date: July 2017
• Source: Somogy Megyei Kaposi Mór Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: November 21, 2017
• Est. primary completion date: November 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Parkinson's disease,

• Hoenh Yahr scale of 2-3,

• instability problem,

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Balance
• Motor Function
• Parkinson Disease
• Rehabilitation

Intervention

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.
• cycling
Patients must undergo a daily exercise cycle of 1 hour during the intervention

Locations

Country	Name	City	State
Hungary	Somogy Megyei Kaposi Mór Teaching Hospital	Kaposvár	Somogy

Sponsors (1)

Lead Sponsor	Collaborator
Somogy Megyei Kaposi Mór Teaching Hospital

Country where clinical trial is conducted

Hungary, 

Outcome

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

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