Condition category
Surgery
Date applied
06/03/2020
Date assigned
11/03/2020
Last edited
16/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Delayed participation in cardiac rehabilitation exercise training promotes muscle atrophy, reduces cardiovascular fitness and prolongs recovery. While the growing evidence base for early cardiac rehabilitation exercise training is relatively compelling, good quality evidence is limited. To date, there have not been studies designed to provide solid evidence through comparing a program of usual standard care with precautions to a program that encourages incremental resistance exercise of the arms in the early period following heart surgery.

Current guidelines recommend restriction from supervised cardiac rehabilitation exercise training for 6  weeks in the management of patients following heart surgery. This is not based on evidence, so potentially unnecessary activity restrictions could be being imposed. There is evidence that supports the safety and feasibility of arm movements and activity following cardiac surgery. There is also no consistency in current practice regarding the clinical recommendations given in terms of arm exercises following cardiac surgery.

Research is needed to establish clinical guidelines for early supervised arms resistance training of patients following heart surgery. The aims of this project are to examine whether early supervised incremental resistance training exercises will improve upper limb function and facilitate recovery following heart surgery.

Who can participate?
Patients over 18 who have planned cardiac surgical procedure, involving a median sternotomy at Hospital Canselor Tuanku Muhriz.

What does the study involve?
If the participants agree to participate in the study, they will undergo initial assessments so that the researcher can determine if they are eligible to participate. If they are eligible, they will be randomly assigned to either receive standard care after their operation or to receive an early supervised incremental resistance training exercise program. Participants will have an equal chance of being assigned to each of the two groups.

If the participant is allocated to receive the early supervised incremental resistance training exercise program, they will be given advice and, arm exercises and breathing exercise to complete. This program will continue for the next four to six weeks with sessions two to three times per week supervised by a physiotherapist at the outpatient Physiotherapy Department. The exercises will increase in intensity weekly based on the health and progress of each participant.

A follow-up assessment will be done in the first week after the operation/before discharge from the hospital, at 4 weeks postoperatively, and then at 3 months postoperatively. Your doctor who will complete these assessments will not know which group you have assigned to but in the case of emergencies, this information will be made available to your doctor.

What are the possible benefits and risks of participating?
The risk of issues arising as a result of participating in this research is very minimal because this research is supported by good evidence and will be supervised by an experienced physiotherapist and the support of the medical team in the participating hospital. In the event of a bodily injury or illness directly resulting from the study, all necessary treatment will be provided.

The study will benefit the participant as it will potentially enhance the recovery process and improve quality of life after the surgery. For participants who are in the group receiving exercise training there will be no significant difference in performing activities of daily living because there are no limits on movement.

Where is the study run from?
1. Hospital Canselor Tuanku Muhriz, UKM (Malaysia)
2. Institul Jantung Negara (Malaysia)
3. Hospital Serdang (Malaysia)

When is the study starting and how long is it expected to run for?
June 2019 to January 2022

Who is funding the study?
University Kebangsaan Malaysia (Malaysia)

Who is the main contact?
Dr Katijjahbe Mohd Ali
katijjahbe@yahoo.com

Trial website

Contact information

Type

Public

Primary contact

Dr Katijjahbe Mohd Ali

ORCID ID

http://orcid.org/0000-0002-1348-3617

Contact details

No 6 Jalan Suadamai
Cheras
Kuala Lumpur
43200
Malaysia
+60 0390766454
katijjahbe@yahoo.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NMRR ID 50763

Study information

Scientific title

Efficacy of Early Supervised Incremental Resistance Training (ESPRiT) following Cardiac Surgery via Median Sternotomy – A Multi- Centre RCT

Acronym

ESPRiT

Study hypothesis

We hypothesize that a program of early supervised incremental upper limb resistance exercise will significantly improve upper limb function, pain, functional capacity, multi-domain recovery, psychological recovery, hospital length of stay, incidence of respiratory complications, recovery of physical function, and health-related quality of life in patients following cardiac surgery via median sternotomy compared with patients receiving standard care.

Ethics approval

Approved 27/02/2020, Research Ethics Committee, The National University of Malaysia (Tingkat 1, Blok Klinikal, Hospital Canselor Tuanku Muhriz, Pusat Perubatan UKM, Jalan Yaacob Latif, Bandar Tun Razak, Cheras, 56000 Kuala Lumpur, Malaysia; +603 9145 5046 / 5048; secukm@ukm.edu.my), ref: JEP-2019-654

Study design

Prospective phase II multi-centre concealed allocation double-blind parallel-group randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format. Please contact katijjahbe @yahoo.com to request participation information sheet

Condition

Cardiac Surgery via Median Sternotomy

Intervention

Current interventions as of 16/03/2020:
Participants will be recruited from patients who are anticipated to undergo cardiac surgery via median sternotomy at Hospital Canselor Tuanku Muhriz. After recruitment and baseline testing, participants will be randomized by an independent person using a computer-generated random number sequence which, will allocate each participant to one of two groups that include standard care or intervention group. Participants will be randomly allocated to either the intervention or the control group at a ratio of 1:1. An administration assistant independent of the trial will prepare the allocation papers and put one in each of 240 sequentially numbered (1 to 240) opaque envelopes.

The standard care group will be given standard post-operative management and the intervention group will be given early progressive incremental resistance training as allocated. Both group sessions will begin and terminate with a warm-up and cool down to avoid any adverse events.

Participants in the intervention group will follow the same care as the control group with the addition of the supervised incremental progressive moderate-intensity exercise of the upper limb. With respect to the sternal precautions, they will be provided with instructions to encourage the use of the upper limb within the safe limit of pain and discomfort as per the protocol previously published by Katijjahbe et al, 2018.

The total duration of each treatment session will be 1 h. All baseline assessments will be performed at the same time of day for each participant in the pre-operative period. The postoperative follow-up assessments will take place after 7 days (+/- 1 day) in the in-patient setting, at 4 weeks (+14 days) in the outpatient setting, and at 3 months (±14 days) which will take place in the research room at the physiotherapy unit. An independent and trained assessor (located off-site) blinded to allocation will conduct all measurement sessions. All follow-up tests and questionnaires will be administered face-to-face by the outcome assessors and carried out prior to discharge, 4 weeks and 3 months post-operatively to ensure consistency across participants.

Post-hospital discharge follow-up will be contacted via phone. If participants are unable to be contacted by phone for a period of 14 consecutive days from the assessment due date, they will be considered lost to follow up for the post-discharge outcomes measurement.

Participants will be assessed using clinical tests and questionnaires for functional capacity, pain and other measures of recovery following completion of care using the protocol.


Previous interventions:
Participants will be recruited from patients who are anticipated to undergo cardiac surgery via median sternotomy at Hospital Canselor Tuanku Muhriz. After recruitment and baseline testing, participants will be randomized by an independent person using a computer-generated random number sequence which, will allocate each participant to one of two groups that include standard care or intervention group. Participants will be randomly allocated to either the intervention or the control group at a ratio of 1:1. An administration assistant independent of the trial will prepare the allocation papers and put one in each of 240 sequentially numbered (1 to 240) opaque envelopes.

The standard care group will be given standard post-operative management and the intervention group will be given early progressive incremental resistance training as allocated. Both group sessions will begin and terminate with a warm-up and cool down to avoid any adverse events.

Participants in the intervention group will follow a supervised incremental progressive moderate-intensity exercise and early mobilization protocol developed by Boden et al, 2018. With respect to the sternal precautions, they will be provided with instructions to encourage the use of the upper limb within the safe limit of pain and discomfort as per the protocol previously published by Katijjahbe et al, 2018.

The total duration of each treatment session will be 1 h. All baseline assessments will be performed at the same time of day for each participant in the pre-operative period. The postoperative follow-up assessments will take place after 7 days (+/- 1 day) in the in-patient setting, at 4 weeks (+14 days) in the outpatient setting, and at 3 months (±14 days) which will take place in the research room at the physiotherapy unit. An independent and trained assessor (located off-site) blinded to allocation will conduct all measurement sessions. All follow-up tests and questionnaires will be administered face-to-face by the outcome assessors and carried out prior to discharge, 4 weeks and 3 months post-operatively to ensure consistency across participants.

Post-hospital discharge follow-up will be contacted via phone. If participants are unable to be contacted by phone for a period of 14 consecutive days from the assessment due date, they will be considered lost to follow up for the post-discharge outcomes measurement.

Participants will be assessed using clinical tests and questionnaires for functional capacity, pain and other measures of recovery following completion of care using the protocol.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Upper limb exercise capacity measured using the unsupported limb exercise test at discharge (or 7 days), 4 weeks, and 3 months

Secondary outcome measures

1. Pain measured by the Numerical Rating Scale For Pain (NPRS) and the Visual Analog Scale (VAS) for pain (FDQ) at discharge (or 7 days), 4 weeks, and 3 months
2. Thoracic physical function measured by the Functional Difficulty Questionnaire (FDQ) shortened version at discharge (or 7 days), 4 weeks, and 3 months
3. Multi-domain recovery measured by the Postoperative Quality Recovery Scale (PostopQRS) at discharge (or 7 days), 4 weeks, and 3 months
4. Functional exercise capacity measured by the 6-Min Walk Test (6MWT) at discharge (or 7 days), 4 weeks, and 3 months
5. Levels of anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) at discharge (or 7 days), 4 weeks, and 3 months
6. Sternal stability measured using the Sternal Instability Scale (SIS) at discharge (or 7 days), 4 weeks, and 3 months
7. Handgrip strength (kg) measured using a handheld dynamometer at discharge (or 7 days), 4 weeks, and 3 months
8. Self-perceived recovery of physical function and quality of life measured using the modified Iowa Level of Assistance Scale (mILOA), the World Health Organisation Disability Assessment Schedule V2 (WHODAS), the Self-Assessment of Physical Activity Questionnaire (SAQ), and the Global Rating of Change (GRC) scales at discharge (or 7 days), 4 weeks, and 3 months
9. Respiratory Complications/Sternal Complications assessed through hospital notes at discharge (or 7 days), or via phone at 4 weeks, and 3 months
10. Hospital Length of Stay (LOS) assessed through hospital notes at discharge
11. Discharge Destination assessed through hospital notes at discharge (or 7 days), 4 weeks, and 3 months
12. Major adverse and cerebral events (MACCE) assessed through hospital notes at discharge (or 7 days), or via phone at 4 weeks, and 3 months

Overall trial start date

04/06/2019

Overall trial end date

29/01/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Anticipated elective cardiac surgical procedure, involving a median sternotomy at Hospital Canselor Tuanku Muhriz
2. Able to provide informed consent
3. Aged ≥18 years.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Insufficient Malay/English comprehension to provide informed consent, complete simple, written questionnaires and/or understand simple, verbal instructions.
2. Deterioration in patient’s condition as determined by their respective cardiothoracic surgeons/teams pre-operatively
3. Unstable coronary or other medical condition
4. Physical impairment that prevents participation in the upper/lower limb and trunk tasks tested in the functional task components. This includes patients who have been diagnosed with severe osteoarthritis, significant rotator cuff injury or who are bed/wheelchair-bound

Recruitment start date

11/03/2020

Recruitment end date

29/01/2022

Locations

Countries of recruitment

Malaysia

Trial participating centre

Hospital Canselor Tuanku Muhriz, UKMMC
Universiti Kebangsaan Malaysia Medical Centre Jalan Yaccob Latiff
Kuala Lumpur
56000
Malaysia

Trial participating centre

Institul Jantung Negara
145, Jalan Tun Razak
Kuala Lumpur
50400
Malaysia

Trial participating centre

Hospital Serdang
Jalan Puchong
Kajang
43000
Malaysia

Sponsor information

Organisation

University Kebangsaan Malaysia Medical Centre

Sponsor details

43600 UKM
Bangi
Selangor
Selangor
43600
Malaysia
+60 111025381
katijjahbe@yahoo.com

Sponsor type

Hospital/treatment centre

Website

http://www.ppukm.ukm.my

Funders

Funder type

University/education

Funder name

Universiti Kebangsaan Malaysia

Alternative name(s)

National University of Malaysia

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Malaysia

Results and Publications

Publication and dissemination plan

The findings will be used to provide evidence-based guidelines for medical practitioners and health care professionals involved in pre and post-operative cardiac surgery care.

Planned publication in a peer-reviewed journal of:
1. Study protocol titled "Efficacy of Early Supervised Incremental Resistance Training (ESPRiT) following Cardiac Surgery via Median Sternotomy – A Multi-Centre RCT Protocol"
2. The results of a pilot study to assess safety and feasibility titled "Efficacy of Early Supervised Incremental Resistance Training (ESPRiT) following Cardiac Surgery via Median Sternotomy – A Pilot RCT"
3. The results of the main trial titled "Efficacy of Early Supervised Incremental Resistance Training (ESPRiT) following Cardiac Surgery via Median Sternotomy – A Multi-Centre RCT"

IPD Sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

We will use the excel database for through training of those who collect, check and enter study data; regular data checks for inconsistency between and within measurements and missing data. The data will be available with publications of the final manuscript as a supplemental document. All data will be obtained following the participants' consent.

Intention to publish date

30/05/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/03/2020: The interventions have been updated. 11/03/2020: The recruitment start date has been changed from 23/03/2020 to 11/03/2020. 09/03/2020: Trial’s existence confirmed by the Research Ethics Committee, The National University of Malaysia.