Does early exercise help recovery after heart surgery? comparing structured interval training with standard care in a randomized study

ISRCTN	ISRCTN13043265
DOI	https://doi.org/10.1186/ISRCTN13043265
Sponsor	National University of Malaysia
Funder	Universiti Kebangsaan Malaysia

Submission date: 07/04/2026
Registration date: 17/04/2026
Last edited: 15/04/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Dr. Nur Ayub Md Ali
Principal investigator

Hospital Canselor Tuanku Muhriz
Jalan Yaacob Latif
Kuala Lumpur
Bandar Tun Razak
Cheras
56000
Malaysia

Phone	+60 0123177845
Email	drnurayub@gmail.com

Dr Katijjahbe Mohd. Ali
Scientific, Public

Hospital Canselor Tuanku Muhriz
Jalan Yaacob Latif
Kuala Lumpur
Bandar Tun Razak
Cheras
56000
Malaysia

Phone	+60 01110253818
Email	katijjahbe@yahoo.com

Prof DR. Mohd Rizal Haji Abdul Manaf
Scientific, Public

Hospital Canselor Tuanku Muhriz
Jalan Yaacob Latif
Kuala Lumpur
Bandar Tun Razak
Cheras
56000
Malaysia

Phone	+60 038921 5555
Email	mrizal@ppukm.ukm.edu.my

Dr Mohamad Nazreen Hisham Nain
Public, Scientific

Hospital Canselor Tuanku Muhriz
Jalan Yaacob Latif
Kuala Lumpur
Bandar Tun Razak
Cheras
56000
Malaysia

Phone	+60 0179636782
Email	drnazreennain@gmail.com

Dr Muhammad Ishamuddin Ismail
Public, Scientific

Hospital Canselor Tuanku Muhriz
Jalan Yaacob Latif
Kuala Lumpur
Bandar Tun Razak
Cheras
56000
Malaysia

Phone	+60 038921 5555
Email	ishamuddin@gmail.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Supportive care, Treatment
Participant information sheet	49327_PIS.pdf
Scientific title	Structured interval training for early mobilization versus standard care after cardiac surgery: effects on mobility and physical function—a randomized controlled trial
Study objectives	1. The goal is to assess how a structured interval training for early mobilization protocol affects physical function and mobility in patients who underwent cardiac surgery via median sternotomy. 2. The objective is to evaluate the effect of a structured interval training for early mobilization protocol on health-related quality of life, unplanned length of stay in the ICU, pain and postoperative pulmonary complications (PPC) in patients who underwent cardiac surgery via median sternotomy.
Ethics approval(s)	Approved 27/05/2025, Universiti Kebangsaan Malaysia (UKM) Research Ethics Secretariate (Level 1, Clinical Block, Hospital Canselor Tuanku Muhriz, Jalan Yaacob Latif, Kuala Lumpur, Bandar Tun Razak, Cheras, 56000, Malaysia; +60 0391455046; sepukm@ukm.edu.my), ref: JEP-2025-193
Health condition(s) or problem(s) studied	Rehabilitation for patient following cardiac surgery.
Intervention	Standard Care (Control Group): Preoperative physiotherapy care will be initiated through education, similar to standard care with an added interval structured for early ambulation protocol based on Boden et al. (2018). This includes instructions on safe movement using the Move in the Tube (MinT) method and the importance of early movement after surgery. After surgery, once the patient is medically stable, the physiotherapist will repeat this education. Patients will also be assessed to identify their risk of developing lung complications after surgery. It will be provided as soon as practical after surgery by a physiotherapist. Patients will receive one supervised ambulation session per day until a threshold score is met or discharge from hospital, whichever occurs first. After the breathing tube is removed, patients will start simple exercises. These include arm, foot, and ankle movements, as well as gradual walking. The physiotherapist will guide patients to continue using the MinT method and to increase their activity step by step until discharge. The key difference from the intervention group is that there is no fixed or structured plan for how long the exercises or walking sessions should be. Intervention Group: Before surgery, patients will receive the same physiotherapy education as the standard care group. In addition, they will follow a structured walking (ambulation) program. After surgery, this program will begin as soon as it is safe. A physiotherapist will supervise one walking session per day until the patient reaches the target level or is discharged. At every session, the participant will be progressed sequentially through the protocol stages. The daily aim for the participant is to achieve stage 6 or greater, aiming to achieve a walking time of at least 10 min, but no more than 15 min, at an intensity of at least three on the Borg 10-point visual analogue scale (VAS) of perceived exertion and where breathing is deeper than at rest. The treating physiotherapist will use a stopwatch to ensure the treatment session does not exceed 15 minutes and can provide a walking aid if clinically indicated. If necessary, ambulation sessions can comprise of equal work/rest intervals. Shorter but not longer rest times are allowable. The final achieved ambulation stage corresponds to total time walked, including the marching on the spot time and not including rest periods. Successful ambulation is defined as continuously marching on the spot beside the bed or walking away from the bedside for more than 1 minute. Time from surgery to time of first successful ambulation will be recorded. If participants are unavailable or unable to achieve ambulation for more than 1 minute, the assisted ambulation session will be attempted once again on the same day. The reasons for participants being unable to ambulate or not achieving a minimum of 10 minutes will be recorded. If a participant is unable to participate in upright ambulation, then no other non-ambulatory exercises will be provided that day. All treating therapists will be provided with protocol badge cards and trained by the site investigator. An allied health assistant can deliver the ambulation protocol once this is deemed safe to do so by the treating physiotherapist. The professional qualification of the person assisting each ambulation session will be documented.
Intervention type	Other
Primary outcome measure(s)	Physical Function measured using The 6-Min Walk Test (6MWT) at baseline (pre-op), before discharge, and 1 month post-operatively Hand Grip Strength measured using Jamar Hand Grip at baseline (pre-op), before discharge, and 1 month post-operatively Mobility measured using the Modified Iowa Level of Assistance (mILOA) at daily from the first postoperative day until day seven
Key secondary outcome measure(s)	Pain measured using Numerical Rating Scale (NRS) for Pain at daily postoperatively until discharge and at 1 month post operatively Quality of life measured using the EQ-5D-5L at pre-operatively, before discharge and 1 month postoperatively. Intensive Care Unit (ICU) length of stay measured using data collected on the number of days spent in the intensive care unit from the day of admission for an acute condition to the day of discharge to the general ward at study end Post Operative Pulmonary Complication (PPC) measured using the Melbourne Group Score at daily until post-op day 7. From post-op days 8 to 14, additional PPC assessments are only performed when clinically suspected based on signs or symptoms of respiratory system deterioration reported within the medical record.
Completion date	30/09/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	90 Years
Sex	All
Target sample size at registration	58
Key inclusion criteria	1. Elective cardiac surgical procedure, involving a median sternotomy 2. Able to provide informed consent 3. Adults over the age of 18 years
Key exclusion criteria	1. Insufficient Malay/English comprehension to provide informed consent 2. Unable to complete simple, written questionnaires, and/or understand simple, verbal instructions 3. Unable to perform physical assessment/6 min walk test 4. Unwilling to participate in the study
Date of first enrolment	01/05/2026
Date of final enrolment	31/08/2026

Locations

Countries of recruitment

Malaysia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other files			15/04/2026	No	No
Participant information sheet			15/04/2026	No	Yes
Protocol file			07/04/2026	No	No

Additional files

49327_Protocol.pdf: Protocol file
49327_PIS.pdf: Participant information sheet
49327_Participant Consent Form_English.pdf: Other files

Editorial Notes

15/04/2026: Study’s existence confirmed by the Universiti Kebangsaan Malaysia (UKM) Research Ethics Secretariate.