Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000832370
Ethics application status
Approved
Date submitted
30/04/2017
Date registered
6/06/2017
Date last updated
6/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of cardiac rehabilitation program on subjective well-being of myocardial infarction patients
Scientific title
Effectiveness of cardiac rehabilitation program on health-related quality of life; A randomized control trial
Secondary ID [1] 291808 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
CRP in MI
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Myocardial infarction 303048 0
Physical medicine / rehabilitation 303049 0
Condition category
Condition code
Cardiovascular 302504 302504 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 302505 302505 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of intervention(s) / exposure: Cardiac rehabilitation (CR) program was the intervention which was a medically supervised program in post myocardial infarction patient. After patients were diagnosed with myocardial infarction by a cardiologist, they were recruited, baseline information recorded and randomized into casual care or casual care plus CR program.
The participants of the CR program (intervention group) were enrolled for a total period of 8 weeks, which was conducted in 2 phases in hospital premises. CR program team consisted of one cardiac consultant, two trained nurses, 1 physiotherapist and 1 dietitian.
CR program consisted following components according to the two phases:
Phase 1: This CR program was of 1-2 weeks duration during hospital stay:
1. Psychological reassurance: A consultant cardiologist conducted a single session of 15-30 minutes at the very start of the patient admission. Participants was encouraged to ask questions or any queries. Any misconceptions were cleared and he/she was reassurance regarding his/her health status and preventive aspects were given.
2. Early mobilization: A trained nurse having an experience of at least 2 years ensured early mobilization of the participant while admitted in the hospital ward. Session consisted of gradual mobilization starting from 1-3 minutes’ walk.
3. Dietary counselling: A dietitian having at least 2 years’ experience conducted two dietary counselling session of 15-30 minutes session per week according to WHO guideline of healthy diet. Healthy food choices were given and unhealthy food were identified by interactive communicative session.
4. Future risk stratification: A consultant cardiologist conducted approximately 15-30 minutes session regarding the participant modifiable risks and how to decrease them.
Phase 2: After 02 weeks they were offered 06 weeks structured exercise program. In this phase, patient were asked to come to the hospital weekly. A schedule appointment was communicated to each patient according to their convenience.
1. Structured exercise program (SEP): The SEP was conducted once weekly by CR team consisting of a trained doctor, physiotherapist and a trained nurse. The program included reassessment by CR team and structured exercise protocol was started for each participant. It consisted of a supervised 30 minutes aerobic and strength exercise training sessions. A total of 6 SEP was conducted in a period of 6 weeks in hospital premises.
2. Health education: A trained nurse having at least 5 years’ experience conducted a 15-30 minutes session on the same day of SEP but before the start of the SEP session. Aim was to increase the understanding of disease process, risk factors, medical compliance and follow up visit.
3. Dietician counselling: A trained dietitian after SEP conducted 15-30 minutes session and reinforced and encouraged the healthy food choices.
The CR program was not individualize or titrated and adherence was not measured.

Intervention code [1] 297920 0
Rehabilitation
Comparator / control treatment
Control group were given the personalized usual care as prescribed by the cardiologist.
Control group
Active

Outcomes
Primary outcome [1] 301916 0
Self-rated health (physiological measure of HRQOL),
Timepoint [1] 301916 0
Baseline and at 6 weeks after intervention commencement
Primary outcome [2] 301917 0
General health questionnaire (psychological measure of HRQOL)
Timepoint [2] 301917 0
Baseline, and at 6 weeks after intervention commencement
Primary outcome [3] 301918 0
MacNew Quality of Life after Myocardial Infarction (MacNew QLMI) (specific measure of HRQOL in myocardial infarction patients)
Timepoint [3] 301918 0
Baseline and at 6 weeks after intervention commencement
Secondary outcome [1] 334275 0
Anthropometric measurements that is height in meters and weight in kilogram were taken by trained data collectors, with standard operating procedures.
Each measurement was taken 3 times and then mean was calculated.
Timepoint [1] 334275 0
Baseline, and at 6 weeks after intervention commencement
Secondary outcome [2] 334571 0
Body mass index (BMI) was calculated by dividing weight in kilograms (measured after removal of shoes and heavy outer clothing using a weight scale machine CAMRY) by the square of height in meters (measured without shoes using a non-stretchable tape).
Timepoint [2] 334571 0
Baseline and at 6 weeks after intervention commencement

Eligibility
Key inclusion criteria
Inclusion criteria consisted of patients of 70 years or below with first attack of myocardial infarction, who received primary treatment in cardiology ward and were discharged from the ward. Those who were willing to participate in the study and came for the sessions of proposed intervention.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included participants with mental illness, who were unable to communicate and who were having physical disability. Patients having “resting systolic BP > 200 mm Hg, diastolic BP >100 mm Hg, ongoing chest pain at rest, decompensated heart failure, severe symptomatic valvular heart disease, complex ventricular arrhythmia, resting paroxysmal supraventricular tachycardia, complex arrhythmia induced by exercise, third degree atrioventricular block without permanent pacemaker, endocarditis, pericarditis, arterial thromboembolism, unable to perform physical exertion” were also excluded from the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was calculated according to Gehan’s Table for calculation of RCT sample . Number of patients needed in each group to detect various differences in Cure Rates; alpha = .05; Power (1-beta) = .80 (two- sided test).
Taking the difference in cure rates between the two groups as 50, it was intended to increase the cure rate by the intervention (CR) to upto 70% so the difference was 20%. Thus keeping in view the 20%, the Gehan's table at 0.20 and the intersecting figure of 0.50 shows is 93 sample size.
Therefore, 93 patients in each intervention and control group and after adding 10% of loss to follow up/non respondents the maximum sample of each group and was increase to 103 and the final total sample size was 206 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/07/2016
Date of last participant enrolment
Anticipated
Actual
1/11/2016
Date of last data collection
Anticipated
Actual
13/12/2016
Sample size
Target
206
Accrual to date
Final
195
Recruitment outside Australia
Country [1] 8855 0
Pakistan
State/province [1] 8855 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 296309 0
Self funded/Unfunded
Name [1] 296309 0
Dr. Zia Ul Haq
Country [1] 296309 0
Pakistan
Primary sponsor type
Individual
Name
Dr. Aliya Hisam
Address
Khyber Medical University
Phase 5, Hayatabad, Peshawar, code =25000
Khyber Pakhtunkhwa, Pakistan
Country
Pakistan
Secondary sponsor category [1] 295236 0
Individual
Name [1] 295236 0
Daud Khan
Address [1] 295236 0
Khyber Medical University
Phase 5, Hayatabad, Peshawar, code =25000
Khyber Pakhtunkhwa, Pakistan
Country [1] 295236 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297539 0
Ethics Board, Khyber Medical University
Ethics committee address [1] 297539 0
Khyber Medical University
Phase 5, Hayatabad, Peshawar, code =25000
Khyber Pakhtunkhwa, Pakistan
Ethics committee country [1] 297539 0
Pakistan
Date submitted for ethics approval [1] 297539 0
02/10/2015
Approval date [1] 297539 0
20/10/2015
Ethics approval number [1] 297539 0
DIR/KMU-AS&RB/EC/000362

Summary
Brief summary
Pakistan being the developing country is facing non-communicable disease burden of 21%. Ischemic heart disease in the leading cause of mortality among Pakistani population. The aspect of secodary prevention of ischemic heart disease in developing countries is the dire need for public health specialists, clinicians and policy makers. There are some evidence that psychotherapeautic measures, including psychotherapy, recreation, exercise and stress management training have positive impact on secondary prevention of cardiovascular diseases but there are some contradictory findings as well. Cardiac rehabilitation program (CRP) post myocardial infarction (MI) is an unexplored aspect in Pakistan specifically Khyber Pakhtunkhwa province. Psychological, physical and specific health-related quality of life (HRQoL) outcomes needs assessment with respect to its practicality, effectiveness and success.
Overall there is lack of published randomized control trials regarding secondary prevention of cardiovascular diseases, particularly in South Asian Region. While searching through search engines like Pub Med and Google Scholar, till January 15th 2015, no such study was found which has been conducted on Pakistani population. This study will give us the true picture and practicality of the effectiveness of cardiac rehabilitation program (CRP) in post myocardial infarction patients in a tertiary health care setup. This study will also provide evidence based medicine to the clinicians and public health physicians regarding secondary prevention of myocardial infarction patients through cost effective strategy i.e. CRP.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1669 1669 0 0
/AnzctrAttachments/372829-Informed consent form.docx (Participant information/consent)
Attachments [2] 1709 1709 0 0
/AnzctrAttachments/372829-372829-Ethical certificate.pdf (Ethics approval)

Contacts
Principal investigator
Name 74374 0
A/Prof Zia Ul Haq
Address 74374 0
Khyber Medical University
Phase 5, Hayatabad, Peshawar, code =25000
Khyber Pakhtunkhwa, Pakistan
Country 74374 0
Pakistan
Phone 74374 0
+92 333 9258763 (for Peshawar, Pakistan)
Fax 74374 0
+92 91 9217258 (for Peshawar, Pakistan)
Email 74374 0
[email protected]
Contact person for public queries
Name 74375 0
A/Prof Aliya Hisam
Address 74375 0
Khyber Medical University
Phase 5, Hayatabad, Peshawar, code =25000
Khyber Pakhtunkhwa, Pakistan
Country 74375 0
Pakistan
Phone 74375 0
+92 321 5111811 (for Peshawar, Pakistan)
Fax 74375 0
Email 74375 0
[email protected]
Contact person for scientific queries
Name 74376 0
A/Prof Dr. Aliya Hisam
Address 74376 0
Khyber Medical University
Phase 5, Hayatabad, Peshawar, code =25000
Khyber Pakhtunkhwa, Pakistan
Country 74376 0
Pakistan
Phone 74376 0
+92 321 5111811 (for Peshawar, Pakistan)
Fax 74376 0
Email 74376 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOral rivaroxaban in symptomatic deep vein thrombosis.2019https://dx.doi.org/10.29271/jcpsp.2019.09.814
N.B. These documents automatically identified may not have been verified by the study sponsor.