Virtual Reality-enhanced Exercise and Education in Cardiac Rehabilitation
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|ClinicalTrials.gov Identifier: NCT03945201|
Recruitment Status : Completed
First Posted : May 10, 2019
Last Update Posted : August 2, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Adherence, Patient Motivation Satisfaction||Other: Virtual walking trails Other: Standard of care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Consent and enrollment process does not mention virtual reality to maintain blinding between control and intervention arms.|
|Official Title:||Effect of a Virtual Reality-enhanced Exercise and Education Intervention on Patient Engagement and Learning in Cardiac Rehabilitation|
|Actual Study Start Date :||January 29, 2018|
|Actual Primary Completion Date :||May 31, 2019|
|Actual Study Completion Date :||July 29, 2019|
Active Comparator: Standard of care
Participants receive normal cardiac rehabilitation according to approved standard of care. They use multiple pieces of exercise equipment at each session for increasing amounts of time and at incrementally increasing levels of difficulty. After establishing a baseline, participants are allowed to use the treadmill for "up to 15 minutes" at each session.
Other: Standard of care
Participants receive normal standard of care cardiac rehabilitation, completing multiple pieces of exercise equipment at increasing intervals according to the Jefferson Methodist Cardiac Rehabilitation program's protocols. Participants are given the option to use the treadmill for "up to" 15 minutes.
Experimental: Virtual walking trails
Participants use multiple pieces of exercise equipment at each session for increasing amounts of time and at incrementally increasing levels of difficulty. After establishing a baseline, participants are allowed to use the treadmill for "up to 15 minutes" at each session. The treadmill is positioned in front of a vertically oriented high definition television screen showing Bionautica Trails, virtual walking trails created by Plas.md.
Other: Virtual walking trails
During time on the treadmill, participants walk in front of Bionautica Trails, the virtual walking trails created by Plas.md. Participants can select between seven trails including various nature themed trails and a space setting. While walking, participants wear wireless headphones that provide audio of cardiac rehabilitation education at random intervals. These education pieces cover six categories of information: Understanding Your Heart Condition, Diet, Exercise, Medication, Managing Risk Factors, and Emotional Health.
Other Name: Bionautica Trails
- Comparison of Participant 6-minute Walk Test Improvement Between Control and Intervention Groups [ Time Frame: From date of enrollment through study completion, an average of 12 weeks ]Each participant will complete a 6MWT at both their first and last cardiac rehab treatment sessions. Distance improvement between first and last treatment session is expected for all participants. Average distance improvement (measured in feet) between study arms will be compared to evaluate effectiveness of interventions.
- Participant Satisfaction with Cardiac Rehab Treatment [ Time Frame: At completion of cardiac rehab treatment, an average of 12 weeks ]All participants are asked to complete a satisfaction survey, utilizing likert scales and location specific questions to evaluate their satisfaction with treatment. Questions delineate the differences between experiences part of standard of care and those specific to the trial.
- Participant Cardiac Education Retention [ Time Frame: At enrollment; at date of treatment completion, average of 12 weeks; two months following treatment completion ]Participants will complete a brief, 5-question, education quiz at several times throughout their rehabilitation treatment. The quiz will be administered to establish a baseline of their cardiac knowledge prior to treatment, at the end of their treatment to evaluate primary comprehension, and again after treatment to evaluate longterm retention of information. Quiz scores and trends will be compared between study arms.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Participants must independently choose or be referred to Jefferson Health Methodist Cardiac Rehabilitation Program for outpatient cardiac rehabilitation.
- Participants must have a referring cardiac condition requiring cardiac rehabilitation therapy.
- Physical inability to use treadmill
- Medically unsafe to use a treadmill for 15 minutes
- Inability to understand English
- Unable to provide consent
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): NCT03945201
|United States, Pennsylvania|
|Jefferson Health Methodist Cardiac Rehabilitation Program|
|Philadelphia, Pennsylvania, United States, 19145|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Thomas Jefferson University|
|Other Study ID Numbers:||
|First Posted:||May 10, 2019 Key Record Dates|
|Last Update Posted:||August 2, 2019|
|Last Verified:||August 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||De-identified participant data will be made available for all gathered data, including primary and secondary outcomes, by request.|
|Time Frame:||Data will be available by request indefinitely.|
|Access Criteria:||Data will be available by request.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|