Multimodal VR Rehabilitation for Cardiorespiratory Fitness in CABG Phase II

December 29, 2025 updated by: Riphah International University

Effects of Multimodal Virtual Reality-based Rehabilitation on Dyspnea, Cardiorespiratory Fitness, Left Ventricular Ejection Fraction, and Quality of Life in CABG Phase II

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Recruiting
        • Riphah International University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Group A: Patients will engage in multimodal circuit training while simultaneously viewing nature scenes through VR in a clinical setting.
Other: 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.
Experimental: Group B
Group B: Patients will be given multimodal circuit training in real -world clinical setting.
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.
Experimental: Group C
Group C: Patients will be given multimodal circuit training through telerehabilitation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dyspnea by Dyspnea 12 questionnaire
Time Frame: 2 months
This 12-item questionnaire was developed to measure the severity of dyspnea. The first seven items of this 4-point Likert-type scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) ask patients about physical difficulties they experience because of dyspnea. The remaining five items of the questionnaire focus on the affective aspects of breathing. The maximum scores for the physical and affective aspects of the questionnaire are 21 and 15, respectively. The minimum total score for the questionnaire is 0, whereas the maximum total score is 36.The higher the score, the more severe will be the dyspnea.
2 months
cardiorespiratory fitness by VO2 max (through Cooper 12 min test)
Time Frame: 2 months

Cooper proposed an indirect approach to estimate VO2 max based on field data. The test can be easily implemented in a common 400 m track field. After a warmup period of about 10 min, subjects are asked to run/ walk as much distance as possible for 12 min. Cooper conducted the test for 105 subjects and found a positive correlation with the value of VO2max quantified via a formal treadmill test. Cooper used linear regression of the covered distance versus the treadmill-estimated VO2 max to find the following relationship:

VO 2 max ≈ 11.288+22.351D12.
2 months
left ventricular ejection fraction [LVEF] by echocardiography
Time Frame: 2 months
LVEF (Left Ventricular Ejection Fraction) by echocardiography is a key measure of heart function, representing the percentage of blood pumped out of the left ventricle with each heartbeat. It is commonly used to assess cardiac efficiency and detect heart failure or other cardiovascular conditions. Echo provides a non-invasive, real-time evaluation of LVEF, offering insights into the heart's pumping capacity and overall health.
2 months
Quality of life by EQ-5D-5L
Time Frame: 2 months
The EQ-5D questionnaire was developed to measure self-reported health simply and generically. It contains a descriptive system that includes the five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/ depression, and a visual analogue scale (the EQ VAS). Both the descriptive system and the EQ VAS measure the current health of the respondent. Combining the respondents' answers in each of the five dimensions of the descriptive system results in a unique health state. On the EQ-VAS, the respondents rate their current health on a scale ranging from 0 to 100. Zero represents "the worst health you can imagine" and 100 represents "the best health you can imagine".
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep by Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 2 months
The PSQI is an 18-item constructed questionnaire designed to assess overall sleep quality over 1 month. The 18 items are divided into 7 derived component scores: (1) sleep quality, (2) sleep latency, (3) sleep duration, (4) sleep efficiency, (5) sleep disturbance, (6) medication use and (7) daytime dysfunction. These items are rated in terms of the frequency or severity of the problem on a four-point Likert scale (e.g., 0 = Not during the past month, 1 = Less than once a week, 2 = Once or twice a week, 3 = Three or more times a week). The sum of the component scores yields a global PSQI score that ranges from 0 to 21, with higher scores representing lower sleep quality.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Wajeeha Zia, PP-DPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2025

Primary Completion (Estimated)

February 25, 2026

Study Completion (Estimated)

February 25, 2026

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Amna Zafar

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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