CTRI

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CTRI Number

CTRI/2025/08/092859 [Registered on: 12/08/2025] Trial Registered Prospectively

Last Modified On:

11/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

In our study we will be including post-CABG patients we will be giving virtual reality exercises to see its effects on early mobility and functional capacity during phase-1 cardiac rehabilitation

Scientific Title of Study

Feasibility of virtual reality exercise training protocol on early mobility and functional capacity during phase-1 cardiac rehabilitation in post-CABG patients-A pilot randomized controlled trial

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Bhakti Ravindra Kakad
Designation	Post Graduate Student
Affiliation	MGM Institue Of Physiotherapy
Address	487,Mhada Colony Opposite Dhoot Hospital Aurangabad Department of cardiorespiratory physiotherapy Aurangabad MAHARASHTRA 431006 India
Phone	9923992530
Fax
Email	bhaktirkakad28@gmail.com

Details of Contact Person
Scientific Query

Name	DrSantosh Dobhal
Designation	Associate Professor
Affiliation	MGM Institue of Physiotherapy
Address	N-6 CIDCO, Aurangabad department of cardiorespiratory physiotherapy Aurangabad MAHARASHTRA 431003 India
Phone	9923401079
Fax
Email	santoshdobhal@mgmiop.edu.in

Details of Contact Person
Public Query

Name	Dr Santosh Dobhal
Designation	Associate Professor
Affiliation	MGM Institue of Physiotherapy
Address	N-6 CIDCO, Aurangabad Department of Cardiorespiratory physiotherapy Aurangabad MAHARASHTRA 431003 India
Phone	9923401079
Fax
Email	santoshdobhal@mgmiop.edu.in

Source of Monetary or Material Support

MGM INSTITUTE OF PHYSIOTHERAPY

Primary Sponsor

Name	MGM Institute of Physiotherapy
Address	N-6 CIDCO Chhtarapati Sanbhajinagar 431003
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DR SANTOSH DOBHAL	MGM Medical College and hospital	cardiac Intensive care unit in MGM medical college and hospital n-6 cidco aurangabad Aurangabad MAHARASHTRA	9923401079 santoshdobhal@mgmiop.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ethics Committee For Research On Human Subject	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: I259\|\|Chronic ischemic heart disease, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	standard cardiac rehabilitation	breathing exercises,ROM exercises of upper limb and lower limb,walking,stair climbing
Intervention	virtual reality exercise training protocol	In this games such as beat saber,maloka,first step should be played through meta quest 2 headset

Inclusion Criteria

Age From	40.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	patients who have undergone coronary artery bypass graft surgery and are at post operative day-3 , haemodynamically stable, cognitive ability to follow VR based rehabilitation instructions willingness to participate and provide informed consent.

ExclusionCriteria

Details

Patients who have neurological deficits limiting mobility,with severe visual or vestibular impairements and had Virtual reality intolerance and severe musculoskeletal conditions preventing mobility exercises.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
PERMES ICU MOBILITY SCALE	PRE AND POST INTERVENTION

Secondary Outcome

Outcome	TimePoints
6 MINUTE WALK TEST	PRE AND POST INTERVENTION

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

01/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

The procedure will begin with obtaining permission from ethical commiitee,followed by trial registration. The study Involved 30 partcipants who were screened and included based on specific eligibility criteria from the CICU of a tertiary care hospital.The demographic data of the partcipants will be noted . partcipants who have undergone Coronary Artery Byapss Surgery (CABG) surgery will be allocated into two groups using block randomization.These participants will receive treatment based on their allocation for seven days post surgery. 15 partcipants ( control group ) will receive standard cardiac rehabilitation and 15 Participants ( intervention group) will receive virtual reality based exercise treatment protocol. Assessments will be conducted both before and after intervention, Early mobility will be measured using Permes ICU mobility scale and functional capacity will be measured using 6 minute walk test.finally based on the results conclusion will be drawn.