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

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ClinicalTrials.gov Identifier: NCT03193268
Recruitment Status : Unknown
Verified July 2017 by Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : June 20, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Tollár József, 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Balance Rehabilitation Motor Function Other: Single-blind RTC of PD patients Other: cycling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of Intensity-matched Agility and Cycling Exercise Training on PD Patients' Clinical Symptoms, Posture, and Mobility
Estimated Study Start Date : October 15, 2017
Estimated Primary Completion Date : November 21, 2017
Estimated Study Completion Date : November 21, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Quality of life [ Time Frame: 5 weeks ]
    Questionnaire

  2. Borg test [ Time Frame: 5 weeks ]
    Fatigue questionnaire

  3. PDQ-39 [ Time Frame: 5 weeks ]
    special Parkinson's Disease test - motor and no-motor function

  4. SPPB test (gait, balance, leg stregth) [ Time Frame: 5 weeks ]
    Walking and balance testing



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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193268


Locations
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Hungary
Somogy Megyei Kaposi Mór Teaching Hospital
Kaposvár, Somogy, Hungary, 7400
Sponsors and Collaborators
Somogy Megyei Kaposi Mór Teaching Hospital

Additional Information:
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Responsible Party: Tollár József, Principal Investoigator, Somogy Megyei Kaposi Mór Teaching Hospital
ClinicalTrials.gov Identifier: NCT03193268     History of Changes
Other Study ID Numbers: IKEB0014/2015
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital:
sensorimotor training
quality of life
posture

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases