Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001491752
Ethics application status
Approved
Date submitted
26/07/2022
Date registered
29/11/2022
Date last updated
3/04/2024
Date data sharing statement initially provided
29/11/2022
Date results provided
29/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative study of the effects of cardiac rehabilitation on autonomic, hemodynamic, metabolic and physical condition parameters among subjects submitted to percutaneous revascularization and bypass due to Acute Coronary Syndrome.
Scientific title
Comparative study of the effects of cardiac rehabilitation on autonomic, hemodynamic, metabolic and physical condition parameters among subjects submitted to percutaneous revascularization and bypass due to Acute Coronary Syndrome.
Secondary ID [1] 307649 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes 327153 0
Percutaneous revascularization 327154 0
Ischaemic heart disease 327155 0
Coronary artery bypass 327156 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324290 324290 0 0
Physiotherapy
Cardiovascular 324291 324291 0 0
Coronary heart disease
Surgery 324637 324637 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention will commence after inpatient discharge. In the outpatient cardiac rehabilitation center
Patient with coronary bypass who will received 12 consecutive weeks of physical training, with a frequency of 3 days per week, 60 minutes per session, consisting on: 5 minutes of warm-up, 40 minutes of work in treadmill and cycloergometer, and a 5-minute cool down. An intensity between 50% and 70% of the reserve heart rate or 3-6 in the modified Borg scale.
In addition, two sessions per week of resistance training in upper extremities with moderate intensity (3-5 modified Borg) in this days the patient will receive 10 minutes of resistant training whit elastic bands of different resistances 4 sets of 8 - 10 reps 3 or 4 exercises like shoulder abduction, elbow flexion and extension and so on, this days the session will take 10 more minutes. The intervention will be delivered by a specialized physiotherapist in cardiopulmonary, and it will be provided individually.
Each day the patient will sign an attendance registry which contents the follow up.
Intervention code [1] 324103 0
Rehabilitation
Intervention code [2] 324362 0
Prevention
Comparator / control treatment
The comparator group will receive the same treatment as the intervention group, however will consist of patients who have undergone percutaneous revascularisation rather than coronary bypass.
Intervention will commence after inpatient discharge. In the outpatient cardiac rehabilitation center
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332104 0
Functional capacity (Mets/Vo2 max)
Instruments: 6 minutes walking tes
Total distance walked during the 6-minute walk test
Timepoint [1] 332104 0
Initial assessment (T0): Prior to the beginning of the intervention.
Second assessment (T1): 12 weeks post commencement of intervention
Primary outcome [2] 332105 0
Cardiovascular Autonomic Control
Instruments: electrocardiographic recording of R-R intervals and analysis of Hearth Rate Variability at rest.
Timepoint [2] 332105 0
Initial assessment (T0): Prior the beginning of the intervention.
Second assessment (T1): 12 weeks post commencement of intervention
Primary outcome [3] 332106 0
Total cholesterol and triglycerides
Instruments: Accutrend plus portable.
both measures will be analysed together as a composite primary outcome.
Timepoint [3] 332106 0
Initial assessment (T0): Prior the beginning of the intervention.
Second assessment (T1): 12 weeks post commencement of intervention
Secondary outcome [1] 412217 0
Glycemia
Glucometer
Timepoint [1] 412217 0
Initial assessment (T0): Prior the beginning of the intervention.
Second assessment (T1): 12 weeks post commencement of intervention

Eligibility
Key inclusion criteria
Subjects over 18 years, residing in Bucaramanga during the study and who are referred to a cardiac rehabilitation program-Phase II, after having undergone percutaneous or bypass revascularization for a first coronary event.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who have absolute or relative contraindications for the performance of physical exercise or the functional capacity test.
-Subjects with ejection fraction <40%.
-Patients with pacemaker implantation.
-Patients with diagnosed arrhythmias.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participant are assign according to if received coronary bypass or percutaneous transluminal coronary angioplasty
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Stata 12.0 software will be used. The difference between measurements will be compared between groups using the Student t-test for independent data; while the intra-group comparison of the change before and after the intervention will be made using the Student t-test for paired data. A level of 5% will be considered for the entire analysis.
Prior A Linear Mixed Model analysis (LMM) will be use to estimate the mean peak VO2
from the mean 6 MWD (minute walk distance)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/06/2022
Date of last participant enrolment
Anticipated
Actual
10/03/2023
Date of last data collection
Anticipated
31/01/2023
Actual
2/06/2023
Sample size
Target
34
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 24917 0
Colombia
State/province [1] 24917 0
SANTANDER

Funding & Sponsors
Funding source category [1] 311910 0
University
Name [1] 311910 0
Universidad de Santander
Country [1] 311910 0
Colombia
Primary sponsor type
Other Collaborative groups
Name
Profesionales de la Salud Ltda.
Address
Calle 46 # 33-16, Bucaramanga, Santander
Country
Colombia
Secondary sponsor category [1] 313395 0
University
Name [1] 313395 0
Universidade de São Paulo
Address [1] 313395 0
Laboratory of Physiology and Cardiovascular Physioterapy, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto 14049-900,
Country [1] 313395 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311346 0
The Institutional Ethics Committee of the University of Santander.
Ethics committee address [1] 311346 0
Ethics committee country [1] 311346 0
Colombia
Date submitted for ethics approval [1] 311346 0
16/11/2021
Approval date [1] 311346 0
25/11/2021
Ethics approval number [1] 311346 0
VII – 108 – BUC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120794 0
Prof Zully Rocio Rincon Rueda
Address 120794 0
Santander University
calle 70 No 55-210 Bucaramanga, Santander
Country 120794 0
Colombia
Phone 120794 0
+573102289525
Fax 120794 0
Email 120794 0
[email protected]
Contact person for public queries
Name 120795 0
Zully Rocio Rincon Rueda
Address 120795 0
Santander University
calle 70 No 55-210 Bucaramanga, Santander
Country 120795 0
Colombia
Phone 120795 0
+57 3102289525
Fax 120795 0
Email 120795 0
[email protected]
Contact person for scientific queries
Name 120796 0
Zully Rocio Rincon Rueda
Address 120796 0
Santander University
calle 70 No 55-210 Bucaramanga, Santander
Country 120796 0
Colombia
Phone 120796 0
+573102289525
Fax 120796 0
Email 120796 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.