NCT03708484

Brief Summary

Randomized controlled trial (single blinded) study was conducted on 26 stable Post MI patients according to inclusion and exclusion criteria aged 35 to 65 years. Study was conducted in Rawalpindi Institute of cardiology and Pakistan Railway Hospital from July 2016 ---- December 2016.Participants was randomly allocated in control or experimental group by lottery Method. Informed consent was signed by each participant prior to enrolment. Patients in both group received standard treatment that is Aerobic Interval training whereas patients in interventional group received additional Resistance training. Post echocardiography and lipid profile was done to assess the effect of intervention on ejection fraction, cholesterol and triglycerides. The standard questionnaire Mac New QLMI was used to assess quality of life. The data was analyzed on SPSS 21

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2016

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

October 13, 2018

Last Update Submit

August 7, 2019

Conditions

Keywords

Aerobic Interval trainingEjection FractionMyocardial InfarctionResistive Interval Training

Outcome Measures

Primary Outcomes (1)

  • Ejection Fraction

    Change from baseline Ejection fraction

    6 weeks

Secondary Outcomes (2)

  • MACNEW QLMI

    6 weeks

  • Lipid profile

    6 weeks

Study Arms (2)

Aerobic Interval Training

ACTIVE COMPARATOR

Aerobic Interval Training is active comparator

Other: Aerobic Interval Training

Aerobic + Resistive Interval Training

EXPERIMENTAL

Aerobic + Resistive Interval Training is experimental

Other: Aerobic + Resistive Interval Training

Interventions

Aerobic Interval Training Patients in this group will perform 6 minutes of cycling followed by 3 minutes of pause and again 6 minutes of cycling followed by 3 minutes of pause and finally 6 minutes of treadmill followed by 3 minutes of rest. both groups will perform cool down exercises that include again breathing exercises, stretching and active exercises.

Aerobic Interval Training

Aerobic + Resistive Interval Training Patients in this group; first set will perform 3 minute of cycling ,1 set of hand grippers 1.5 to 2.5 lbs (10 to 12 reps) and 1 set of biceps resistive exercises 1 Kg to 3 kg (10 to 12 reps) followed by 3minute of pause. In second set patient will perform 3 minutes of stationary cycling , 1 set of quadriceps resistive exercises 1 to 3 Kg (10 to 12 reps) again followed by 3 minutes of pause and in third set patient will perform 3 minutes of treadmill walk at 1.5 to 4 speed, and 1 set of standing ankle pumps (10 to 12 reps). both groups will perform cool down exercises that include again breathing exercises, stretching and active exercises.

Aerobic + Resistive Interval Training

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who experienced just 1 episode of MI
  • Stable post MI patients after 6 weeks of MI episode
  • Patient who remained asymptomatic for first 3 minutes of ETT

You may not qualify if:

  • Poor LV ejection fraction below 35 % was excluded
  • Lung diseases ( lung function test moderate and severe intensity )
  • Unstable MI patients
  • Those who had undergone any cardiac surgery
  • Patients with Post MI Arrhythmias were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (25)

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    PMID: 18036459BACKGROUND
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    PMID: 20972578BACKGROUND
  • Suaya JA, Shepard DS, Normand SL, Ades PA, Prottas J, Stason WB. Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery. Circulation. 2007 Oct 9;116(15):1653-62. doi: 10.1161/CIRCULATIONAHA.107.701466. Epub 2007 Sep 24.

    PMID: 17893274BACKGROUND
  • Kannel WB, Abbott RD. Incidence and prognosis of unrecognized myocardial infarction. An update on the Framingham study. N Engl J Med. 1984 Nov 1;311(18):1144-7. doi: 10.1056/NEJM198411013111802.

    PMID: 6482932BACKGROUND
  • Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. 2000 Sep;36(3):959-69. doi: 10.1016/s0735-1097(00)00804-4.

    PMID: 10987628BACKGROUND
  • Tully PJ, Baker RA. Depression, anxiety, and cardiac morbidity outcomes after coronary artery bypass surgery: a contemporary and practical review. J Geriatr Cardiol. 2012 Jun;9(2):197-208. doi: 10.3724/SP.J.1263.2011.12221.

    PMID: 22916068BACKGROUND
  • Wenger NK. Current status of cardiac rehabilitation. J Am Coll Cardiol. 2008 Apr 29;51(17):1619-31. doi: 10.1016/j.jacc.2008.01.030.

    PMID: 18436113BACKGROUND
  • 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
  • Williams MA, Ades PA, Hamm LF, Keteyian SJ, LaFontaine TP, Roitman JL, Squires RW. Clinical evidence for a health benefit from cardiac rehabilitation: an update. Am Heart J. 2006 Nov;152(5):835-41. doi: 10.1016/j.ahj.2006.05.015.

    PMID: 17070142BACKGROUND
  • Gielen S, Laughlin MH, O'Conner C, Duncker DJ. Exercise training in patients with heart disease: review of beneficial effects and clinical recommendations. Prog Cardiovasc Dis. 2015 Jan-Feb;57(4):347-55. doi: 10.1016/j.pcad.2014.10.001. Epub 2014 Oct 22.

    PMID: 25459973BACKGROUND
  • Blanchard CM, Courneya KS, Rodgers WM, Fraser SN, Murray TC, Daub B, Black B. Is the theory of planned behavior a useful framework for understanding exercise adherence during phase II cardiac rehabilitation? J Cardiopulm Rehabil. 2003 Jan-Feb;23(1):29-39. doi: 10.1097/00008483-200301000-00007.

    PMID: 12576910BACKGROUND
  • Franklin BA, Bonzheim K, Gordon S, Timmis GC. Safety of medically supervised outpatient cardiac rehabilitation exercise therapy: a 16-year follow-up. Chest. 1998 Sep;114(3):902-6. doi: 10.1378/chest.114.3.902. No abstract available.

    PMID: 9743182BACKGROUND
  • Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.

    PMID: 17548726BACKGROUND
  • Molmen-Hansen HE, Stolen T, Tjonna AE, Aamot IL, Ekeberg IS, Tyldum GA, Wisloff U, Ingul CB, Stoylen A. Aerobic interval training reduces blood pressure and improves myocardial function in hypertensive patients. Eur J Prev Cardiol. 2012 Apr;19(2):151-60. doi: 10.1177/1741826711400512. Epub 2011 Mar 4.

    PMID: 21450580BACKGROUND
  • Kemi OJ, Wisloff U. High-intensity aerobic exercise training improves the heart in health and disease. J Cardiopulm Rehabil Prev. 2010 Jan-Feb;30(1):2-11. doi: 10.1097/HCR.0b013e3181c56b89.

    PMID: 20040880BACKGROUND
  • Karlsdottir AE, Foster C, Porcari JP, Palmer-McLean K, White-Kube R, Backes RC. Hemodynamic responses during aerobic and resistance exercise. J Cardiopulm Rehabil. 2002 May-Jun;22(3):170-7. doi: 10.1097/00008483-200205000-00008.

    PMID: 12042685BACKGROUND
  • Pollock ML, Franklin BA, Balady GJ, Chaitman BL, Fleg JL, Fletcher B, Limacher M, Pina IL, Stein RA, Williams M, Bazzarre T. AHA Science Advisory. Resistance exercise in individuals with and without cardiovascular disease: benefits, rationale, safety, and prescription: An advisory from the Committee on Exercise, Rehabilitation, and Prevention, Council on Clinical Cardiology, American Heart Association; Position paper endorsed by the American College of Sports Medicine. Circulation. 2000 Feb 22;101(7):828-33. doi: 10.1161/01.cir.101.7.828. No abstract available.

    PMID: 10683360BACKGROUND
  • Cornelissen VA, Fagard RH, Coeckelberghs E, Vanhees L. Impact of resistance training on blood pressure and other cardiovascular risk factors: a meta-analysis of randomized, controlled trials. Hypertension. 2011 Nov;58(5):950-8. doi: 10.1161/HYPERTENSIONAHA.111.177071. Epub 2011 Sep 6.

    PMID: 21896934BACKGROUND
  • Leon AS, Sanchez OA. Response of blood lipids to exercise training alone or combined with dietary intervention. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S502-15; discussion S528-9. doi: 10.1097/00005768-200106001-00021.

    PMID: 11427777BACKGROUND
  • Tokmakidis SP, Volaklis KA. Training and detraining effects of a combined-strength and aerobic exercise program on blood lipids in patients with coronary artery disease. J Cardiopulm Rehabil. 2003 May-Jun;23(3):193-200. doi: 10.1097/00008483-200305000-00006.

    PMID: 12782903BACKGROUND
  • White HD, Norris RM, Brown MA, Brandt PW, Whitlock RM, Wild CJ. Left ventricular end-systolic volume as the major determinant of survival after recovery from myocardial infarction. Circulation. 1987 Jul;76(1):44-51. doi: 10.1161/01.cir.76.1.44.

    PMID: 3594774BACKGROUND
  • Meta-analysis Global Group in Chronic Heart Failure (MAGGIC). The survival of patients with heart failure with preserved or reduced left ventricular ejection fraction: an individual patient data meta-analysis. Eur Heart J. 2012 Jul;33(14):1750-7. doi: 10.1093/eurheartj/ehr254. Epub 2011 Aug 6.

    PMID: 21821849BACKGROUND
  • Haddadzadeh MH, Maiya AG, Padmakumar R, Shad B, Mirbolouk F. Effect of exercise-based cardiac rehabilitation on ejection fraction in coronary artery disease patients: a randomized controlled trial. Heart Views. 2011 Apr;12(2):51-7. doi: 10.4103/1995-705X.86013.

    PMID: 22121461BACKGROUND
  • Pierson LM, Herbert WG, Norton HJ, Kiebzak GM, Griffith P, Fedor JM, Ramp WK, Cook JW. Effects of combined aerobic and resistance training versus aerobic training alone in cardiac rehabilitation. J Cardiopulm Rehabil. 2001 Mar-Apr;21(2):101-10. doi: 10.1097/00008483-200103000-00007.

    PMID: 11314283BACKGROUND
  • Kang K, Gholizadeh L, Inglis SC, Han HR. Interventions that improve health-related quality of life in patients with myocardial infarction. Qual Life Res. 2016 Nov;25(11):2725-2737. doi: 10.1007/s11136-016-1401-8. Epub 2016 Sep 3.

    PMID: 27592108BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Imran Amjad, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2018

First Posted

October 17, 2018

Study Start

July 1, 2016

Primary Completion

December 20, 2016

Study Completion

December 25, 2016

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations