Effects of Cardiac Rehabilitation (CR) on Functional Capacity and Cardiovascular Risk Factors

NCT ID: NCT02575976

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-10-31

Brief Summary

The purpose of this trial are to pragmatically investigate whether participation in a comprehensive CR (i.e., exercise with education) program in a Latin American MIC results in better functional capacity, cardiovascular risk factor control, health behavior, disease-related knowledge, depressive symptoms and lower mortality when compared exercise only CR or wait list control.

Detailed Description

The design is a single-blinded, single-site pragmatic superiority RCT with 3 parallel arms: comprehensive CR (education and exercise) versus exercise-based CR (no education, as delivered in Brazil) versus wait list control (i.e., no CR). Patient assessments will be undertaken pre-randomization and again at 6 and 12 months later (in accordance with the end of CR). Mortality will be ascertained at 6 months and 1 year post-recruitment.

The main program is 6 months in duration, with 36 1-hour exercise sessions offered at the following frequencies:

1. participants come to CR for 12 sessions, 3x a week (total of 4 weeks of intervention).

2. participants come to CR for 8 sessions, 2x a week (total of 4 weeks of intervention).

3. participants come to CR for 12 sessions, 1x a week (total of 12 weeks of intervention).

Each participant will receive an individualized exercise prescription based on a grade exercise stress test. Participants will be exercising between 50 and 80% of heart rate reserve. In all stages patients will be requested to exercise in their community other days of the week, to accumulate 30 or more minutes of physical activity at a moderate to vigorous-intensity 5 or more days per week, as recommended in the guidelines.

In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration. More specifically, the education component consists of:

• weekly group education sessions, which are strategically mapped based on patients' information needs and sequenced to support the program learning outcomes. Education sessions are delivered by a health educator team. See table 1 for the CR program schedule, including educational topics (e.g.. diet, medication and exercise).
• A comprehensive education workbook to accompany the sessions, containing 20 chapters. The empirically-validated English version has been translated and culturally-adapted to Brazilian-Portuguese. Clinicians and patients have reviewed the material, and a plain language and clear design review was completed in preparation for this trial.

The standard of care for Brazilian adults with CVD does not include access to CR for all patients, given the gross lack of capacity. All participants will have follow-up appointments with their physician as deemed medically appropriate. Consistent with CONSORT guidelines, usual care will be described in detail for each participant (e.g., number of health visits - both inpatient and outpatient, other treatments).

The number of patients approached and date will be recorded, as well as the reasons for inclusion/exclusion. With informed written consent from the patient and CR clearance from the physician, potentially eligible participants will be scheduled to come on-site to complete pre-test assessments. Participants will be asked to complete a sociodemographic questionnaire, to establish the generalizability of the sample, among other surveys. Clinical information will be extracted from participants' charts.

Eligible participants will be randomized to one of the 3 groups. The randomization sequence was generated using the random.org website in random blocks of 4, with a 1:1:1 allocation ratio. To ensure allocation concealment, the local principal investigator has the allocation sequence in a password-protected file, and will only provide randomization information to the student once it is confirmed the participant is eligible. Due to the nature of the intervention, participants and the doctoral student cannot be blind to treatment allocation.

The primary outcome of functional capacity will be assessed again at 6 months. All other post-test assessments will be undertaken 6 months post-randomization. Mortality will be ascertained from hospital charts and family phone call at 6 months and 1-year. With regard to the baseline and 6 months assessments, participants will be invited to come to the study center to:

1. undertake the shuttle walk test as the indicator of functional capacity,

2. undertake assessments of secondary outcomes including a blood draw for lipids, and

3. complete surveys related to tertiary outcomes.

A master's student blinded to random allocation will undertake post-test assessments, outcome ascertainment and data entry. To minimize loss to follow-up, investigators will send mail and telephone reminders for patients to come on-site for these assessments, based on the Dillman method.

Measures Participants will be asked to complete a sociodemographic questionnaire. Clinical characteristics will be extracted from the medical charts, including sex, age, risk factors, cardiac history, cardiac test results, comorbidities and medications. These are based on the Canadian Cardiovascular Society core element and demographic data definitions. CR session attendance will be extracted from program charts at post-test for participants randomized to the CR arms.

Conditions

Cardiovascular Disease; Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

comprehensive CR

education and exercise-based cardiac rehabilitation

Group Type: EXPERIMENTAL

comprehensive CR

Intervention Type: BEHAVIORAL

In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)

exercise-based CR

Exercise-based cardiac rehabilitation

Group Type: ACTIVE_COMPARATOR

exercise-based CR

Intervention Type: OTHER

The main program is 6 months in duration, with 36 1-hour exercise sessions.

wait list control

no cardiac rehabilitation

Group Type: OTHER

wait list control

Intervention Type: OTHER

No cardiac rehabilitation.

Interventions

comprehensive CR

In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)

Intervention Type: BEHAVIORAL

exercise-based CR

The main program is 6 months in duration, with 36 1-hour exercise sessions.

Intervention Type: OTHER

wait list control

No cardiac rehabilitation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients older than 18 years old
• patients living in the Belo Horizonte area

Exclusion Criteria

• any comorbid physical or serious mental condition which would interfere with the ability to exercise according to CR clinical practice guidelines (i.e., heart failure with ejection fraction less than 45%, complex ventricular dysrhythmia, advanced dementia, leg amputation, advanced cancer, disabling stroke, Parkinson's or substance dependence), and
• any visual or cognitive condition which would preclude the participant from completing the questionnaires.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Raquel Rodrigues Britto

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raquel R Britto, Post doc

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

References

Aldcroft SA, Taylor NF, Blackstock FC, O'Halloran PD. Psychoeducational rehabilitation for health behavior change in coronary artery disease: a systematic review of controlled trials. J Cardiopulm Rehabil Prev. 2011 Sep-Oct;31(5):273-81. doi: 10.1097/HCR.0b013e318220a7c9.

Reference Type: BACKGROUND

PMID: 21734590 (View on PubMed)

Dusseldorp E, van Elderen T, Maes S, Meulman J, Kraaij V. A meta-analysis of psychoeduational programs for coronary heart disease patients. Health Psychol. 1999 Sep;18(5):506-19. doi: 10.1037//0278-6133.18.5.506.

Reference Type: BACKGROUND

PMID: 10519467 (View on PubMed)

Mullen PD, Mains DA, Velez R. A meta-analysis of controlled trials of cardiac patient education. Patient Educ Couns. 1992 Apr;19(2):143-62. doi: 10.1016/0738-3991(92)90194-n.

Reference Type: BACKGROUND

PMID: 1299819 (View on PubMed)

Schadewaldt V, Schultz T. Nurse-led clinics as an effective service for cardiac patients: results from a systematic review. Int J Evid Based Healthc. 2011 Sep;9(3):199-214. doi: 10.1111/j.1744-1609.2011.00217.x.

Reference Type: BACKGROUND

PMID: 21884449 (View on PubMed)

Ghisi GL, Abdallah F, Grace SL, Thomas S, Oh P. A systematic review of patient education in cardiac patients: do they increase knowledge and promote health behavior change? Patient Educ Couns. 2014 May;95(2):160-74. doi: 10.1016/j.pec.2014.01.012. Epub 2014 Jan 30.

Reference Type: BACKGROUND

PMID: 24529720 (View on PubMed)

Chaves GS, Ghisi GL, Grace SL, Oh P, Ribeiro AL, Britto RR. Effects of comprehensive cardiac rehabilitation on functional capacity and cardiovascular risk factors in Brazilians assisted by public health care: protocol for a randomized controlled trial. Braz J Phys Ther. 2016 Nov-Dec;20(6):592-600. doi: 10.1590/bjpt-rbf.2014.0192. Epub 2016 Oct 27.

Reference Type: BACKGROUND

PMID: 27849287 (View on PubMed)

Herdy AH, Lopez-Jimenez F, Terzic CP, Milani M, Stein R, Carvalho T, Serra S, Araujo CG, Zeballos PC, Anchique CV, Burdiat G, Gonzalez K, Gonzalez G, Fernandez R, Santibanez C, Rodriguez-Escudero JP, Ilarraza-Lomeli H. South American guidelines for cardiovascular disease prevention and rehabilitation. Arq Bras Cardiol. 2014 Aug;103(2 Suppl 1):1-31. doi: 10.5935/abc.2014s003. No abstract available. English, Portuguese.

Reference Type: BACKGROUND

PMID: 25387466 (View on PubMed)

Grace SL, Turk-Adawi KI, Contractor A, Atrey A, Campbell NR, Derman W, Ghisi GL, Sarkar BK, Yeo TJ, Lopez-Jimenez F, Buckley J, Hu D, Sarrafzadegan N. Cardiac Rehabilitation Delivery Model for Low-Resource Settings: An International Council of Cardiovascular Prevention and Rehabilitation Consensus Statement. Prog Cardiovasc Dis. 2016 Nov-Dec;59(3):303-322. doi: 10.1016/j.pcad.2016.08.004. Epub 2016 Aug 17.

Reference Type: BACKGROUND

PMID: 27542575 (View on PubMed)

Chaves GSDS, Ghisi GLM, Grace SL, Oh P, Ribeiro AL, Britto RR. Effects of comprehensive cardiac rehabilitation on functional capacity in a middle-income country: a randomised controlled trial. Heart. 2019 Mar;105(5):406-413. doi: 10.1136/heartjnl-2018-313632. Epub 2018 Oct 3.

Reference Type: RESULT

PMID: 30282639 (View on PubMed)

Chaves GSS, Lima de Melo Ghisi G, Britto RR, Grace SL. Maintenance of Gains, Morbidity, and Mortality at 1 Year Following Cardiac Rehabilitation in a Middle-Income Country: A Wait-List Control Crossover Trial. J Am Heart Assoc. 2019 Feb 19;8(4):e011228. doi: 10.1161/JAHA.118.011228.

Reference Type: RESULT

PMID: 30764702 (View on PubMed)

Ghisi GLM, Chaves GSS, Ribeiro AL, Oh P, Britto RR, Grace SL. Comprehensive Cardiac Rehabilitation Effectiveness in a Middle-Income Setting: A RANDOMIZED CONTROLLED TRIAL. J Cardiopulm Rehabil Prev. 2020 Nov;40(6):399-406. doi: 10.1097/HCR.0000000000000512.

Reference Type: DERIVED

PMID: 32694454 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RCT-898235

Identifier Type: -

Identifier Source: org_study_id