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Recruiting NCT04804202

Virtual Cycling Environments for Persons With Parkinson Disease

No phase Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bicycling with and without virtual reality.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Virtual Cycling Environments (VCYCLE) Increases Exercise Intensity of Persons With Parkinson Disease

Overview

This study asks three questions about Persons with Parkinson Disease that use a bicycle for exercise. 1. Does the use of virtual reality increase the intensity and and enjoyment of the experience compared to bicycling without virtual reality? 2. Does the way in which the bicycling (interval compared to continous) is performed affect the experience? 3. How does the way the virtual reality is delivered (with goggles or projected on a screen) affect the experience?

Detailed description

Participants attend two sessions. They complete movement assessments and questionnaires about physical activity. During the first session they bicycle in a semi-immersive (projected on a screen) and an immersive (with googles) virtual environment. After each bout they completed a questionnaire about the experience. In the second session they bicycle four times with and without a virtual environment using both a continous and interval mode. Their oxygen consumption is measured during cycling. They complete questionnaires after each exercise bout.

Interventions

  • Other Bicycling with and without virtual reality
    In one session: Exercise intensity and enjoyment are measured while participants bicycle in a virtual compared to non-virtual environment. Cycling takes places in two modes continous and interval. In a second session exercise intensity and enjoyment are compared during bicycling with virtual reality presented in two different ways.

Primary outcome measures

  • Neuromuscular Intensity [Time frame: Collected in two sessions: Session 1(day 1 for 2 hours) collected continuously during 2 exercise bouts to compare exercise bouts.____Session 2 (day 2 for 2 hours) collected continuously in four exercise bouts to compare exercise bouts]
  • Physiological Responses to Exercise- Oxygen Consumption [Time frame: Collected in two sessions: Session 1(day 1 for 2 hours) collected continuously during 2 exercise bouts to compare exercise bouts___ Session 2 (day 2 for 2 hours) collected continuously in four exercise bouts to compare exercise bouts]
  • Enjoyment-Motivation [Time frame: Collected in two sessions: Session 1 collected continuously during 2 exercise bouts in a 2 hour Session 2: in four exercise bouts in a 2 hour session to compare exercise bouts]
  • Heart Rate % of maximum [Time frame: Collected in two sessions: Session 1 collected continuously during 2 exercise bouts in a 2 hour Session 2: in four exercise bouts in a 2 hour session to compare exercise bouts]
Secondary outcome measures (4)
  • Borg Scale for Rate of perceived exertion [Time frame: Collected in both Day 1 and 2 (each day is two hours) as follows: Day 1 (4 times in each of the two cycling bouts) Day 2 (6 times each of the four cycling bouts)]
  • Cyber sickness Questionnaire [Time frame: Collected in Day 1 (2 hour session) twice to compare before and after scores]
  • Perceived Effort Ranking [Time frame: Collected in once in day 1 and once in day 2]
  • Enjoyment Ranking [Time frame: Collected in once in day 1 and once in day 2]

Eligibility criteria

Inclusion criteria

  • Diagnosis of Parkinson's disease
  • Hoehn and Yahr stages II-III,
  • 45-75 years old
  • able to ride a stationary upright bicycle
  • able to sign informed consent.

Exclusion criteria

  • Have a recent history of severe heart disease, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than Parkinson Disease.
  • Are unable to follow directions or sign a consent form
  • Do not have adequate vision or hearing ability to see or hear a television
  • Have unstable medical condition or musculoskeletal disorder such as severe arthritis, recent knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to ride the bicycle
  • Have any other medical condition that prevents bicycling
  • Have moderate depression

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 2 centers
  • School of Health Professions — Newark
  • New York Institute of Technology — Old Westbury

Identifiers

NCT: NCT04804202 · Pro202000518 · R15AG063348-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗