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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03193268
Other study ID # IKEB0014/2015
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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,

Study Design


Related Conditions & MeSH terms


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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