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Completed

NCT Number: NCT03193268

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.

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Key information

Conditions

Parkinson Disease Balance Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Motor Function Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Rehabilitation Synucleinopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Somogy Megyei Kaposi Mór Teaching Hospital

Kaposvár, Somogy County, 7400, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Single-blind RTC of PD patients

Other

The groups participate in observation for 5 weeks. Two groups take part in a motion therapy over the 5-week period.

Cycling

Other

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

Primary outcomes

  1. EQ5D-5L

    Time frame: 0-5 scale (5 weeks-long, the higher score is better)

    Questionnaire

  2. Borg test

    Time frame: 0-40 point (5 week-long, higher score is better)

    Fatigue questionnaire

  3. PDQ-39

    Time frame: 0-39 scale (5week-long, higher score is better)

    special Parkinson's Disease test - motor and no-motor function

  4. SPPB test (gait, balance, leg stregth)

    Time frame: 0-12 scale (5 week-long, higher score is better)

    Walking and balance testing

Sponsors and collaborators

Lead sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 20, 2017
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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