Multimodal VR Rehabilitation for Cardiorespiratory Fitness in CABG Phase II

NCT ID: NCT07331558

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-02

Study Completion Date

2026-02-25

Brief Summary

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It will be a randomized clinical trial with a sample size of 66. A convenient sampling technique will be used to recruit the CABG phase II patients for the study. Then, they will be divided into three groups by block randomization. Weight-bearing Liuzijue Qigong will be given as a baseline treatment to all groups. In group A, patients will engage in multimodal circuit training while simultaneously viewing the nature scenes through VR in a clinical setting, in group B, patients will be given multimodal circuit training in a clinical setting while in group C, patients will be given multimodal circuit training through telerehabilitation. The dyspnea 12 Questionnaire will be used for measuring dyspnea, Cooper's 12-minute test will be used to assess cardiorespiratory fitness, echocardiography will be used to assess Left ventricular ejection fraction, EQ-5D-5L will be used to assess quality of life, and Pittsburgh Sleep Quality Index (PSQI) will be used to assess the quality of sleep. Data will be entered and analyzed through SPSS version 21.

Detailed Description

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CABG Phase II rehabilitation typically begins a few weeks after hospital discharge and is a structured, medically supervised program aimed at stabilizing patients post-surgery. During this phase, patients often struggle with limited physical capacity, reduced exercise tolerance, and fatigue. Effective cardiac rehabilitation during this critical recovery phase is essential for optimizing health outcomes. Multimodal rehabilitation approaches have been shown to enhance recovery. The integration of innovative techniques like Virtual Reality (VR) into these multimodal programs can further engage patients. The objective of the study is to determine the effects of multimodal virtual reality-based rehabilitation on dyspnea, cardiorespiratory fitness, left ventricular ejection fraction, and quality of life in CABG phase II patients.

It will be a randomized clinical trial with a sample size of 66. A convenient sampling technique will be used to recruit the CABG phase II patients for the study. Then, they will be divided into three groups by block randomization. Weight-bearing Liuzijue Qigong will be given as a baseline treatment to all groups. In group A, patients will engage in multimodal circuit training while simultaneously viewing the nature scenes through VR in a clinical setting, in group B, patients will be given multimodal circuit training in a clinical setting while in group C, patients will be given multimodal circuit training through telerehabilitation. The dyspnea 12 Questionnaire will be used for measuring dyspnea, Cooper's 12-minute test will be used to assess cardiorespiratory fitness, echocardiography will be used to assess Left ventricular ejection fraction, EQ-5D-5L will be used to assess quality of life, and Pittsburgh Sleep Quality Index (PSQI) will be used to assess the quality of sleep. Data will be entered and analyzed through SPSS version 21.

Conditions

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CABG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

Group A: Patients will engage in multimodal circuit training while simultaneously viewing nature scenes through VR in a clinical setting.

Group Type EXPERIMENTAL

multimodal circuit training while viewing nature scenes through VR in a clinical setting

Intervention Type OTHER

This will take place in a clinical setting where participants will also view the nature scenes through virtual reality (VR). The approach is multimodal, incorporating education through a booklet, physical activity via circuit training, nutritional counselling with a healthy diet prescription, and psychological well-being enhanced by behavioural cognitive therapy.

Group B

Group B: Patients will be given multimodal circuit training in real -world clinical setting.

Group Type EXPERIMENTAL

multimodal circuit training in a real-world clinical setting

Intervention Type OTHER

This will take place in a real-world clinical setting. The approach is multimodal, incorporating education through a booklet, physical activity via circuit training, nutritional counselling with a healthy diet prescription, and psychological well-being enhanced by behavioural cognitive therapy.

Group C

Group C: Patients will be given multimodal circuit training through telerehabilitation.

Group Type EXPERIMENTAL

multimodal circuit training through telerehabilitation

Intervention Type OTHER

This will take place through Google Meetings. The approach is multimodal, incorporating education through a booklet, physical activity via circuit training, nutritional counselling with a healthy diet prescription, and psychological well-being enhanced by behavioural cognitive therapy.

Interventions

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multimodal circuit training while viewing nature scenes through VR in a clinical setting

This will take place in a clinical setting where participants will also view the nature scenes through virtual reality (VR). The approach is multimodal, incorporating education through a booklet, physical activity via circuit training, nutritional counselling with a healthy diet prescription, and psychological well-being enhanced by behavioural cognitive therapy.

Intervention Type OTHER

multimodal circuit training in a real-world clinical setting

This will take place in a real-world clinical setting. The approach is multimodal, incorporating education through a booklet, physical activity via circuit training, nutritional counselling with a healthy diet prescription, and psychological well-being enhanced by behavioural cognitive therapy.

Intervention Type OTHER

multimodal circuit training through telerehabilitation

This will take place through Google Meetings. The approach is multimodal, incorporating education through a booklet, physical activity via circuit training, nutritional counselling with a healthy diet prescription, and psychological well-being enhanced by behavioural cognitive therapy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who underwent CABG surgery will be recruited after twelve weeks
* Both male and female
* Age 30-60 years old
* LVEF of \< 40%
* Persistent dyspnea with a self-rated intensity of ⩾5 (out of 10) on a visual analogue dyspnea scale (this dyspnea rating was only used as an inclusion criterion and not as a measure for outcome)
* Preserved cognitive function (Montreal Cognitive Assessment score \>24)

Exclusion Criteria

* Patient with recurrent history of CABG
* Had a non-cardiac surgical procedure ≤2 months prior to recruitment
* Unstable angina, uncontrolled hypertension (blood pressure \>180/100 mmHg), a pacemaker or atrial fibrillation, documented peak orifice area valve stenosis, symptomatic peripheral arterial disease that limits exercise capacity.
* Documented chronic obstructive pulmonary disease (FEV1 \<60% and FVC \<60%)
* Any shoulder impairment that would limit exercise participation
* Patients with Kinesiophobia
* Epilepsy, vertigo, eyesight impairment (conditions contraindicated for VR)
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wajeeha Zia, PP-DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Riphah International University

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Wajeeha Zia, PP-DPT

Role: CONTACT

03234500788

Facility Contacts

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Wajeeha Zia

Role: primary

03234500788

References

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Elbrond P, Hojskov IE, Missel M, Borregaard B. Food and heart-the nutritional jungle: Patients' experiences of dietary habits and nutritional counselling after coronary artery bypass grafting. J Clin Nurs. 2020 Jan;29(1-2):85-93. doi: 10.1111/jocn.15061. Epub 2019 Oct 2.

Reference Type BACKGROUND
PMID: 31512796 (View on PubMed)

Ramos-Campo DJ, Andreu Caravaca L, Martinez-Rodriguez A, Rubio-Arias JA. Effects of Resistance Circuit-Based Training on Body Composition, Strength and Cardiorespiratory Fitness: A Systematic Review and Meta-Analysis. Biology (Basel). 2021 Apr 28;10(5):377. doi: 10.3390/biology10050377.

Reference Type BACKGROUND
PMID: 33924785 (View on PubMed)

Zamzmi G, Rajaraman S, Hsu LY, Sachdev V, Antani S. Real-time echocardiography image analysis and quantification of cardiac indices. Med Image Anal. 2022 Aug;80:102438. doi: 10.1016/j.media.2022.102438. Epub 2022 Jun 9.

Reference Type BACKGROUND
PMID: 35868819 (View on PubMed)

Gungor S, Tosun B, Unal N, Dusak I. Evaluation of dyspnea severity and sleep quality in patients with novel coronavirus. Int J Clin Pract. 2021 Oct;75(10):e14631. doi: 10.1111/ijcp.14631. Epub 2021 Jul 20.

Reference Type BACKGROUND
PMID: 34260144 (View on PubMed)

Rutkowski S, Szczegielniak J, Szczepanska-Gieracha J. Evaluation of the Efficacy of Immersive Virtual Reality Therapy as a Method Supporting Pulmonary Rehabilitation: A Randomized Controlled Trial. J Clin Med. 2021 Jan 18;10(2):352. doi: 10.3390/jcm10020352.

Reference Type BACKGROUND
PMID: 33477733 (View on PubMed)

Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. Evaluation of the Impact of Virtual Reality-Enhanced Cardiac Rehabilitation on Depressive and Anxiety Symptoms in Patients with Coronary Artery Disease: A Randomised Controlled Trial. J Clin Med. 2021 May 16;10(10):2148. doi: 10.3390/jcm10102148.

Reference Type BACKGROUND
PMID: 34065625 (View on PubMed)

Moneruzzaman M, Sun WZ, Changwe GJ, Wang YH. Efficacy of Multiple Exercise Therapy after Coronary Artery Bypass Graft: A Systematic Review of Randomized Control Trials. Rev Cardiovasc Med. 2023 May 9;24(5):141. doi: 10.31083/j.rcm2405141. eCollection 2023 May.

Reference Type BACKGROUND
PMID: 39076757 (View on PubMed)

Dimitriadis S, Qian E, Irvine A, Harky A. Secondary Prevention Medications Post Coronary Artery Bypass Grafting Surgery-A Literature Review. J Cardiovasc Pharmacol Ther. 2021 Jul;26(4):310-320. doi: 10.1177/1074248420987445. Epub 2021 Jan 29.

Reference Type BACKGROUND
PMID: 33514291 (View on PubMed)

Montrief T, Koyfman A, Long B. Coronary artery bypass graft surgery complications: A review for emergency clinicians. Am J Emerg Med. 2018 Dec;36(12):2289-2297. doi: 10.1016/j.ajem.2018.09.014. Epub 2018 Sep 8.

Reference Type BACKGROUND
PMID: 30217621 (View on PubMed)

Pooria A, Pourya A, Gheini A. Postoperative complications associated with coronary artery bypass graft surgery and their therapeutic interventions. Future Cardiol. 2020 Sep;16(5):481-496. doi: 10.2217/fca-2019-0049. Epub 2020 Jun 4.

Reference Type BACKGROUND
PMID: 32495650 (View on PubMed)

McNichols B, Spratt JR, George J, Rizzi S, Manning EW, Park K. Coronary Artery Bypass: Review of Surgical Techniques and Impact on Long-Term Revascularization Outcomes. Cardiol Ther. 2021 Jun;10(1):89-109. doi: 10.1007/s40119-021-00211-z. Epub 2021 Jan 30.

Reference Type BACKGROUND
PMID: 33515370 (View on PubMed)

Other Identifiers

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Amna Zafar

Identifier Type: -

Identifier Source: org_study_id

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