NCT02265107

Brief Summary

Objective: To observe the effects of exercise training on vascular endothelial function in patients undergoing coronary artery bypass graft (CABG) alone in phase III after six months of Cardiac rehabilitation programs (CRP). Methods: the investigators contacted all patients undergoing CABG alone in period of 1 year to participate in a CRP with duration of six months with three weekly sessions of 1 and half hour of the duration. All patients underwent biochemical blood tests, muscle strength testing of one repetition maximum (1-RM test) for upper and lower limbs, 6-minute walk test (6MWT), and evaluation of endothelial function (using flow-mediated vasodilation).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 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, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
Last Updated

October 17, 2014

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

October 7, 2014

Last Update Submit

October 16, 2014

Conditions

Keywords

endothelial functionphysical trainingexercisecoronary artery bypass

Outcome Measures

Primary Outcomes (1)

  • Vascular endothelial function

    after 6 months

Other Outcomes (1)

  • 6-minute walk test

    6 months

Study Arms (1)

cardiac rehabilitation

EXPERIMENTAL

We invited all consecutive patients submitted to CABG alone at Cardiologic Hospital Doctor Pedro Bertoni of the AssociaĂ§Ă£o de Caridade Santa Casa do Rio Grande in the period of October, 2011 until October, 2012, who resided in the city of the Rio Grande (RS/Brazil), to participate of the exercise training (ET). All patients were evaluated by cardiologist, and were ranked in Functional Classification of New York Heart Association (NYHA) such class I and II. Initially, twenty-four patients accepted and start to participate of ET, but only nine patients completed the program until the end.

Other: exercise training

Interventions

The program of exercise training (ET) was employed for 6 consecutive months with 3 sessions per week. The training of physical activity consisted of a combination of aerobic and resistance exercises for upper and lower limbs. Each session included: (1) 5-minute warm-up, (2) 30 minutes of aerobic exercise (performed in treadmills and stationary bikes); (3) 20 minutes of resistance exercises with dumbbells for upper limbs and ankle support for lower limbs (exercises preformed in diagonals) that consisted of 6 sets of 10 resistance exercises repeated for upper limbs, and the same number of sets for lower limbs; and (4) 5-minute cool-down, totaling ninety minutes of session per day (90min/day) and, two hundred and seventy minutes per week (270min/week).

Also known as: cardiac rehabilitation
cardiac rehabilitation

Eligibility Criteria

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

You may qualify if:

  • resided in the city of the Rio Grande (RS/Brazil);
  • age over 18 years-old;
  • evaluation and medical authorization.

You may not qualify if:

  • the patients that performed others cardiologic procedures with the Coronary Artery Bypass Graft

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Priscila Aikawa

Rio Grande, Rio Grande do Sul, 96200-320, Brazil

Location

Related Publications (21)

  • Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ, Thompson PD, Williams MA, Lauer MS; American Heart Association; Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention); Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity); American association of Cardiovascular and Pulmonary Rehabilitation. Cardiac rehabilitation and secondary prevention of coronary heart disease: an American Heart Association scientific statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration with the American association of Cardiovascular and Pulmonary Rehabilitation. Circulation. 2005 Jan 25;111(3):369-76. doi: 10.1161/01.CIR.0000151788.08740.5C.

    PMID: 15668354BACKGROUND
  • Vuckovic KM, Piano MR, Phillips SA. Effects of exercise interventions on peripheral vascular endothelial vasoreactivity in patients with heart failure with reduced ejection fraction. Heart Lung Circ. 2013 May;22(5):328-40. doi: 10.1016/j.hlc.2012.12.006. Epub 2013 Jan 20.

    PMID: 23340198BACKGROUND
  • Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi: 10.1016/j.amjmed.2004.01.009.

    PMID: 15121495BACKGROUND
  • Luk TH, Dai YL, Siu CW, Yiu KH, Chan HT, Lee SW, Li SW, Fong B, Wong WK, Tam S, Lau CP, Tse HF. Effect of exercise training on vascular endothelial function in patients with stable coronary artery disease: a randomized controlled trial. Eur J Prev Cardiol. 2012 Aug;19(4):830-9. doi: 10.1177/1741826711415679. Epub 2011 Jul 1.

    PMID: 21724681BACKGROUND
  • Morikawa Y, Mizuno Y, Harada E, Katoh D, Kashiwagi Y, Morita S, Yoshimura M, Uemura S, Saito Y, Yasue H. Aerobic interval exercise training in the afternoon reduces attacks of coronary spastic angina in conjunction with improvement in endothelial function, oxidative stress, and inflammation. Coron Artery Dis. 2013 May;24(3):177-82. doi: 10.1097/MCA.0b013e32835cbef5.

    PMID: 23249633BACKGROUND
  • Anagnostakou V, Chatzimichail K, Dimopoulos S, Karatzanos E, Papazachou O, Tasoulis A, Anastasiou-Nana M, Roussos C, Nanas S. Effects of interval cycle training with or without strength training on vascular reactivity in heart failure patients. J Card Fail. 2011 Jul;17(7):585-91. doi: 10.1016/j.cardfail.2011.02.009. Epub 2011 Apr 22.

    PMID: 21703531BACKGROUND
  • Credeur DP, Mariappan N, Francis J, Thomas D, Moraes D, Welsch MA. Vasoreactivity before and after handgrip training in chronic heart failure patients. Atherosclerosis. 2012 Nov;225(1):154-9. doi: 10.1016/j.atherosclerosis.2012.08.013. Epub 2012 Sep 16.

    PMID: 23010159BACKGROUND
  • Shechter M, Shechter A, Koren-Morag N, Feinberg MS, Hiersch L. Usefulness of brachial artery flow-mediated dilation to predict long-term cardiovascular events in subjects without heart disease. Am J Cardiol. 2014 Jan 1;113(1):162-7. doi: 10.1016/j.amjcard.2013.08.051. Epub 2013 Oct 5.

    PMID: 24169007BACKGROUND
  • Lerman A, Zeiher AM. Endothelial function: cardiac events. Circulation. 2005 Jan 25;111(3):363-8. doi: 10.1161/01.CIR.0000153339.27064.14. No abstract available.

    PMID: 15668353BACKGROUND
  • Fiorina C, Vizzardi E, Lorusso R, Maggio M, De Cicco G, Nodari S, Faggiano P, Dei Cas L. The 6-min walking test early after cardiac surgery. Reference values and the effects of rehabilitation programme. Eur J Cardiothorac Surg. 2007 Nov;32(5):724-9. doi: 10.1016/j.ejcts.2007.08.013. Epub 2007 Sep 18.

    PMID: 17881241BACKGROUND
  • Signori LU, Quadros AS, Sbruzzi G, Dipp T, Lopes RD, Schaan BD. Endothelial function in patients with slow coronary flow and normal coronary angiography. Clinics (Sao Paulo). 2012;67(6):677-80. doi: 10.6061/clinics/2012(06)22. No abstract available.

    PMID: 22760911BACKGROUND
  • Lee KW, Blann AD, Jolly K, Lip GY; BRUM Investigators. Plasma haemostatic markers, endothelial function and ambulatory blood pressure changes with home versus hospital cardiac rehabilitation: the Birmingham Rehabilitation Uptake Maximisation Study. Heart. 2006 Dec;92(12):1732-8. doi: 10.1136/hrt.2006.092163. Epub 2006 Jun 28.

    PMID: 16807272BACKGROUND
  • Hambrecht R, Wolf A, Gielen S, Linke A, Hofer J, Erbs S, Schoene N, Schuler G. Effect of exercise on coronary endothelial function in patients with coronary artery disease. N Engl J Med. 2000 Feb 17;342(7):454-60. doi: 10.1056/NEJM200002173420702.

    PMID: 10675425BACKGROUND
  • Gokce N, Vita JA, Bader DS, Sherman DL, Hunter LM, Holbrook M, O'Malley C, Keaney JF Jr, Balady GJ. Effect of exercise on upper and lower extremity endothelial function in patients with coronary artery disease. Am J Cardiol. 2002 Jul 15;90(2):124-7. doi: 10.1016/s0002-9149(02)02433-5.

    PMID: 12106840BACKGROUND
  • Edwards DG, Schofield RS, Lennon SL, Pierce GL, Nichols WW, Braith RW. Effect of exercise training on endothelial function in men with coronary artery disease. Am J Cardiol. 2004 Mar 1;93(5):617-20. doi: 10.1016/j.amjcard.2003.11.032.

    PMID: 14996592BACKGROUND
  • Ades PA. Cardiac rehabilitation and secondary prevention of coronary heart disease. N Engl J Med. 2001 Sep 20;345(12):892-902. doi: 10.1056/NEJMra001529. No abstract available.

    PMID: 11565523BACKGROUND
  • Opasich C, De Feo S, Pinna GD, Furgi G, Pedretti R, Scrutinio D, Tramarin R. Distance walked in the 6-minute test soon after cardiac surgery: toward an efficient use in the individual patient. Chest. 2004 Dec;126(6):1796-801. doi: 10.1378/chest.126.6.1796.

    PMID: 15596676BACKGROUND
  • Opasich C, Pinna GD, Mazza A, Febo O, Riccardi PG, Capomolla S, Cobelli F, Tavazzi L. Reproducibility of the six-minute walking test in patients with chronic congestive heart failure: practical implications. Am J Cardiol. 1998 Jun 15;81(12):1497-500. doi: 10.1016/s0002-9149(98)00218-5.

    PMID: 9645905BACKGROUND
  • Lee DH, Buth KJ, Martin BJ, Yip AM, Hirsch GM. Frail patients are at increased risk for mortality and prolonged institutional care after cardiac surgery. Circulation. 2010 Mar 2;121(8):973-8. doi: 10.1161/CIRCULATIONAHA.108.841437. Epub 2010 Feb 16.

    PMID: 20159833BACKGROUND
  • Kim C, Kim BO, Lim KB, Kim YJ, Park YB. The Effect of Power-walking in Phase 2 Cardiac Rehabilitation Program. Ann Rehabil Med. 2012 Feb;36(1):133-40. doi: 10.5535/arm.2012.36.1.133. Epub 2012 Feb 29.

    PMID: 22506246BACKGROUND
  • Pavy B, Caillon M. [Effects of a cardiac rehabilitation programme in coronary patient according to age]. Ann Cardiol Angeiol (Paris). 2012 Nov;61(5):338-44. doi: 10.1016/j.ancard.2012.08.038. Epub 2012 Aug 30. French.

    PMID: 23021239BACKGROUND

Related Links

MeSH Terms

Conditions

AneurysmMotor Activity

Interventions

ExerciseCardiac Rehabilitation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priscila Aikawa PhD

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 15, 2014

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 17, 2014

Record last verified: 2014-10

Locations