NCT02575976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

April 28, 2022

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

2.6 years

First QC Date

October 12, 2015

Results QC Date

November 27, 2018

Last Update Submit

April 26, 2022

Conditions

Cardiovascular DiseaseCoronary Disease

Keywords

RehabilitationCoronary artery diseasePatient EducationRandomized Controlled TrialProtocol

Outcome Measures

Primary Outcomes (1)

  • Functional Capacity Assessed by Changes in Total Distance Walked in the Incremental Shuttle Walk Test

    The Incremental Shuttle Walk Test (ISWT). The ISWT consists of an incremental, walking test where participants are required to walk up and down a 10-meter course. The speed of walking, which is increased by a small increment every minute (0.17 ms-l), is externally paced and controlled by audio signals played from a tape recorder19. There are 12 levels in total, beginning with 0.5 ms-1, and each level lasts for one minute. At the end of each minute, exercise heart rate (HR) and rating of perceived exertion (RPE) scores will be recorded. For this test, the higher the number of meters, the higher the functional capacity.

    Functional capacity measured by walked distance in the ISWT at 6 months

Secondary Outcomes (4)

  • Risk Factors Measurement of Systolic Blood Pressure

    Systolic blood pressure measured at 6 months

  • Risk Factors Measurement of Waist Circumference.

    Waist circumference measured at 6 months

  • Risk Factors Measurement of Fasting Blood Glucose Values

    Glycaemia measured at 6 months

  • Risk Factors Measurement of Total Cholesterol Values.

    Cholesterol measured at 6 months.

Other Outcomes (1)

  • Heart-health Behaviors

    Measured at 6 months.

Study Arms (3)

comprehensive CR

EXPERIMENTAL

education and exercise-based cardiac rehabilitation

Behavioral: comprehensive CR

exercise-based CR

ACTIVE COMPARATOR

Exercise-based cardiac rehabilitation

Other: exercise-based CR

wait list control

OTHER

no cardiac rehabilitation

Other: wait list control

Interventions

comprehensive CRBEHAVIORAL

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)

comprehensive CR
exercise-based CROTHER

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

exercise-based CR
wait list controlOTHER

No cardiac rehabilitation.

wait list control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Related Publications (11)

  • 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.

    PMID: 21734590BACKGROUND

  • 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.

    PMID: 10519467BACKGROUND

  • 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.

    PMID: 1299819BACKGROUND

  • 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.

    PMID: 21884449BACKGROUND

  • 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.

    PMID: 24529720BACKGROUND

  • 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.

    PMID: 27849287BACKGROUND

  • 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.

    PMID: 25387466BACKGROUND

  • 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.

    PMID: 27542575BACKGROUND

  • 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.

    PMID: 30282639RESULT

  • 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.

    PMID: 30764702RESULT

  • 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.

    PMID: 32694454DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Results Point of Contact

Title
Professor Raquel Britto
Organization
Federal University of Minas Gerais
r3britto@gmail.com
+55 31 99970-4527

Study Officials

  • Raquel R Britto, Post doc

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 12, 2015

First Posted

October 15, 2015

Study Start

March 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

April 28, 2022

Results First Posted

April 28, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)