Home-based Cardiac Rehabilitation: Compliance and Effectiveness

NCT03605992 | Completed

• 1 other identifier: FMMinasGerais
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The proposal of this study is to verify if it is feasible and effective to offer a home based cardiac rehabilitation program, that includes the components of health education and physical exercises mostly unsupervised and oriented by telephone and to compare the treatment adherence, the effects in the functional capacity, and the control of coronary risk factors in relation to the traditional cardiac rehabilitation offered mostly supervised and center based.

Conditions

Cardiovascular Diseases; Coronary Disease; Cardiac Disease

Keywords

Rehabilitation; Coronary artery disease; Home-based; Randomized Controlled Trial; Protocol

Outcome Measures

Primary Outcomes (1)

• Change in adherence on CR sessions

  it will be analyzed by the percentage of participants which completed the minimum of 75% of the sessions

  after 3 and 6 months of the intervention

Secondary Outcomes (13)

• Cost

  after 3 and 6 months of the intervention

• Usability

  For TeleRehab group after 3 months of the intervention

• Change in morbidity

  after 3 and 6 months of the intervention

• Change in quality of life

  At baseline, after 3 and 6 months

• Change in scores of depression

  At baseline, after 3 and 6 months

Study Arms (2)

Home-based Rehabilitation

EXPERIMENTAL

Home-based cardiac rehabilitation that includes the components of education and physical exercises mainly unsupervised and oriented by telephone.

Other: Home-based Rehab

CentreRehabilitation

ACTIVE COMPARATOR

Traditional cardiac rehabilitation offered at the outpatient centre including components of education and physical exercises mainly supervised.

Other: CentreRehab

Interventions

Home-based Rehab OTHER

This intervention will have the duration of 12 weeks, with a total of 60 sessions: 2 supervised and 58 at home (to complete five exercise's sessions for week).

Home-based Rehabilitation

CentreRehab OTHER

This intervention will last 12 weeks, with a total of 60 sessions: 24 supervised and 36 at home (to complete five exercise's sessions for week).

CentreRehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with coronary disease submitted to angioplasty or myocardial revascularization surgery, or that had a heart attack, provided they are considered of a low and moderate risk for the practice of physical exercise of moderate intensity according to the stratification for the risk of events during a cardiovascular rehabilitation program
• Clinical stability, according with the medical evaluation;
• Residents of the Belo Horizonte's metropolitan region.

You may not qualify if:

• Recent cardiac event or clinical decompensation (\<1month);
• Presence of peripheral arterial occlusive disease with limitation degree that prevents the test of maximum exercise (emergence of claudication before the maximum cardiorespiratory fatigue);
• Presence of chronic pulmonary disease (i.e. Chronic Obstructive Pulmonary Disease, pulmonary fibrosis, and pulmonary arterial hypertension of pre capillary etiology);
• History of ventricular fibrillation or sustained ventricular tachycardia in the last year;
• Presence of high risk criteria during the ergometric test;
• Physical, cognitive, or social limitation that prevent the participation in a physical exercise program, and the comprehension of the use of the monitoring device.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Related Publications (7)

• Mezzani A, Hamm LF, Jones AM, McBride PE, Moholdt T, Stone JA, Urhausen A, Williams MA; European Association for Cardiovascular Prevention and Rehabilitation; American Association of Cardiovascular and Pulmonary Rehabilitation; Canadian Association of Cardiac Rehabilitation. Aerobic exercise intensity assessment and prescription in cardiac rehabilitation: a joint position statement of the European Association for Cardiovascular Prevention and Rehabilitation, the American Association of Cardiovascular and Pulmonary Rehabilitation, and the Canadian Association of Cardiac Rehabilitation. J Cardiopulm Rehabil Prev. 2012 Nov-Dec;32(6):327-50. doi: 10.1097/HCR.0b013e3182757050.

  PMID: 23103476 RESULT

• Varnfield M, Karunanithi M, Lee CK, Honeyman E, Arnold D, Ding H, Smith C, Walters DL. Smartphone-based home care model improved use of cardiac rehabilitation in postmyocardial infarction patients: results from a randomised controlled trial. Heart. 2014 Nov;100(22):1770-9. doi: 10.1136/heartjnl-2014-305783. Epub 2014 Jun 27.

  PMID: 24973083 RESULT

• Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.

  PMID: 1494764 RESULT

• Coutinho-Myrrha MA, Dias RC, Fernandes AA, Araujo CG, Hlatky MA, Pereira DG, Britto RR. Duke Activity Status Index for cardiovascular diseases: validation of the Portuguese translation. Arq Bras Cardiol. 2014 Apr;102(4):383-90. doi: 10.5935/abc.20140031. Epub 2014 Feb 17.

  PMID: 24652056 RESULT

• Santos IS, Tavares BF, Munhoz TN, Almeida LS, Silva NT, Tams BD, Patella AM, Matijasevich A. [Sensitivity and specificity of the Patient Health Questionnaire-9 (PHQ-9) among adults from the general population]. Cad Saude Publica. 2013 Aug;29(8):1533-43. doi: 10.1590/0102-311x00144612. Portuguese.

  PMID: 24005919 RESULT

• Ghisi GLM, Sandison N, Oh P. Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV. Patient Educ Couns. 2016 Mar;99(3):443-447. doi: 10.1016/j.pec.2015.11.002. Epub 2015 Nov 7.

  PMID: 26610390 RESULT

• Lima AP, Nascimento IO, Oliveira ACA, Martins THS, Pereira DAG, Britto RR. Home-Based Cardiac Rehabilitation in Brazil's Public Health Care: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Nov 7;8(11):e13901. doi: 10.2196/13901.

  PMID: 31697246 DERIVED

Related Links

• American Association for Cardiovascular and Pulmonary Rehabilitation. Guidelines for Cardiac Rehabilitation and Secondary Prevention Programs. 5th ed. Champaign.Human Kinetics Publishers; 2013.
• CICONELLI, R.M. et al. Brazilian Portuguese version of the SF-36. A reliable and valid quality of life outcome measure. Rev. Bras. Reumatol., v.39, n.3, p.143-50, 1999.

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Raquel R Britto, Post doc

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

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: Full Professor

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: July 30, 2018
• Study Start: February 26, 2018
• Primary Completion: September 30, 2019
• Study Completion: October 30, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)