Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000363987
Ethics application status
Approved
Date submitted
29/10/2019
Date registered
16/03/2020
Date last updated
16/03/2020
Date data sharing statement initially provided
16/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a 8 and 12-week exercise program on aerobic capacity after percutaneous revascularization in subjects with Acute Coronary Syndromes
Scientific title
Effect of a 8 and 12-week exercise program on aerobic capacity after percutaneous revascularization in subjects with Acute Coronary Syndromes
Secondary ID [1] 299265 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes
 314945 0
Condition category
Condition code
Cardiovascular 313292 313292 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 2
Context of intervention: outpatient rehabilitation clinic
12 weeks group: 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) for 10 minutes using elastic bands. The intervention will be delivered by a specialized physiotherapist in cardiopulmonary, and it will be provided individually. In order to monitor adherence to to the intervention a session attendance checklist will be used
Intervention code [1] 315883 0
Rehabilitation
Comparator / control treatment
8 weeks group: 8 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 with moderate intensity (3-5 modified Borg) for 10 minutes. The intervention will be delivered by a specialized physiotherapy in cardiopulmonar rehabilitation, and it will be provided individually
Control group
Active

Outcomes
Primary outcome [1] 321787 0
Primary outcome: Functional capacity (Mets/Vo2 max)
Instruments: 6 minutes walking test
Timepoint [1] 321787 0
Initial assessment (T0): Previous the beginning of the intervention.
Second assessment (T1): 8 weeks post commencement of intervention
Third assessment (T2): 12 weeks post commencement of intervention

no primary timepoint is stablished
Secondary outcome [1] 376209 0
Adverse cardiovascular events, such as: Dyspnea, syncope, nausea and heart attack. They will be assessed through clinical examination and participant self-reported.
Timepoint [1] 376209 0
only if presented, they will be assessed for the 12 weeks of the study

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 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
All subjects who have received or are receiving phase II cardiac rehabilitation treatment after percutaneous revascularization. In addition, those who have absolute or relative contraindications for the performance of physical exercise or the functional capacity test. Finally subjects who doesnt complete the 80% of the programmed physical exercise sessions will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A non-probabilistic sampling will be performed for convenience. It will be done by simple random assignment (sealed opaque envelope).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The Stata 12.0 software was used to calculate the sample size and the functional capacity results obtained in the study by Golabchi et al. (20): Group A: 9.7 ± 1.7 Mets; Group B: 8.6 ± 2.2 Mets; with an alpha level of 0.05, a power of 80, a ratio of 1 between groups and an alpha of 0.05. Finally, the sample size obtained was 51 participants for each group; However, considering 20 percent of losses, the number of patients to be recruited will be 60 in each group.

Observation: When considering the time offered for the study and its complexity, preliminary results of 40 patients (20 in each group) will be presented. The sample will be completed in a subsequent study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/03/2019
Date of last participant enrolment
Anticipated
13/04/2020
Actual
Date of last data collection
Anticipated
13/07/2020
Actual
Sample size
Target
40
Accrual to date
16
Final
Recruitment outside Australia
Country [1] 21963 0
Colombia
State/province [1] 21963 0
Santander

Funding & Sponsors
Funding source category [1] 303798 0
University
Name [1] 303798 0
Universidad Santo Tomás, Seccional Bucaramanga
Country [1] 303798 0
Colombia
Funding source category [2] 304130 0
University
Name [2] 304130 0
Universidad de Santander
Country [2] 304130 0
Colombia
Funding source category [3] 304131 0
Other Collaborative groups
Name [3] 304131 0
Profesionales de la Salud CIA LTDA.
Country [3] 304131 0
Colombia
Primary sponsor type
Individual
Name
Juan Carlos Sánchez Delgado
Address
calle 70 No 55-210 Bucaramanga, Santander
Programa de Fisioterapia
Country
Colombia
Secondary sponsor category [1] 304356 0
Individual
Name [1] 304356 0
Adriana Jácome Hortúa
Address [1] 304356 0
Universidad de Santander- UDES
calle 70 No 55-210 Bucaramanga, Santander
Programa de Fisioterapia
Country [1] 304356 0
Colombia
Secondary sponsor category [2] 304361 0
Individual
Name [2] 304361 0
Andrea Juliana Ortiz Patiño
Address [2] 304361 0
Universidad de Santander- UDES
calle 70 No 55-210 Bucaramanga, Santander
Programa de Fisioterapia
Country [2] 304361 0
Colombia
Other collaborator category [1] 281004 0
Individual
Name [1] 281004 0
carmen juliana villamizar jaimes
Address [1] 281004 0
Profesionales de la Salud y CIA LTDA
Calle 46 # 33-16, Bucaramanga, Santander
Country [1] 281004 0
Colombia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304317 0
Ethics Committee of Universidad Santo Tomás de Bucaramanga
Ethics committee address [1] 304317 0
Ethics committee country [1] 304317 0
Colombia
Date submitted for ethics approval [1] 304317 0
Approval date [1] 304317 0
14/02/2019
Ethics approval number [1] 304317 0

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

Contacts
Principal investigator
Name 96514 0
Prof Juan Carlos Sánchez Delgado
Address 96514 0
calle 70 No 55-210 Bucaramanga, Santander
Programa de Fisioterapia
Country 96514 0
Colombia
Phone 96514 0
+57 3157207661
Fax 96514 0
Email 96514 0
[email protected]
Contact person for public queries
Name 96515 0
Juan Carlos Sánchez Delgado
Address 96515 0
calle 70 No 55-210 Bucaramanga, Santander
Programa de Fisioterapia
Country 96515 0
Colombia
Phone 96515 0
+57 3157207661
Fax 96515 0
Email 96515 0
[email protected]
Contact person for scientific queries
Name 96516 0
Juan Carlos Sánchez Delgado
Address 96516 0
calle 70 No 55-210 Bucaramanga, Santander
Programa de Fisioterapia
Country 96516 0
Colombia
Phone 96516 0
+57 3157207661
Fax 96516 0
Email 96516 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
We have no intention to share this data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5483Informed consent form    378364-(Uploaded-29-10-2019-01-37-28)-Study-related document.doc
5484Statistical analysis plan  [email protected]
5485Study protocol  [email protected]



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.