NCT03857282

Brief Summary

To improve the cardiopulmonary endurance in Coronary artery bypass grafting (CABG) patients. Internationally in cardiac hospital facility of cardiac rehabilitation is available to improve the patient's physical activity and decrease the list of secondary complications. But in Pakistan ideal phase II cardiac rehabilitation is limited available in limited hospitals due to cost issues and limited resources for monitoring during exercise. A Randomized control trail Study was conducted in Armed force institute of cardiology (AFIC) Rawalpindi. The Total sample size was 74 post (CABG). The aim of study was to influence of Tai chai on coronary artery bypass surgery patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable coronary-artery-disease

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

February 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

February 8, 2019

Last Update Submit

August 7, 2019

Conditions

Keywords

BicyclingCoronary Artery DiseasePulmonary FunctionTai Chi

Outcome Measures

Primary Outcomes (4)

  • forced expiratory volume in one second (FEV1)

    Changes from the Baseline, forced expiratory volume in one second (FEV1) in liters will be measured through Digital spirometer

    6 weeks

  • Forced vital capacity (FVC)

    Changes from the Baseline, forced vital capacity (FVC) in liters will be measured through Digital spirometer

    6 weeks

  • Peak expiratory flow (PEF).

    Changes from the Baseline, Peak expiratory flow (PEF) in Liters/seconds will be measured through Digital spirometer

    6 weeks

  • International physical activity questionnaire (IPAQ)

    Changes from Baseline, (IPAQ) It is recommended that activity bouts of greater than 3 hours are truncated. That is to say that a bout cannot be longer than 3 hours (180 minutes). This means that in each category a maximum of 21 hours of activity are permitted a week (3 hours X 7 days) To calculate metabolic equivalent (MET) minutes a week multiply the MET value given (remember walking = 3.3, moderate activity = 4, vigorous activity = 8) by the minutes the activity was carried out and again by the number of days that that activity was undertaken. For example if someone reports walking for 30 minutes 5 days a week then the total MET minutes for that activity are 3.3 X 30 X 5=495 Met minutes a week. You can add the MET minutes achieved in each category (walking, moderate activity and vigorous activity) to get total MET minutes of physical activity a week.

    6 weeks

Secondary Outcomes (6)

  • Modified Borg's rating of perceived exertion (RPE) scale

    6 weeks

  • Heart Rate

    6 weeks

  • Oxygen Saturation (SPO2)

    6 weeks

  • Blood Pressure

    6 weeks

  • Heart Rate Reserve

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Aerobic Exercises

ACTIVE COMPARATOR

Bicycling Exercise (lower Limb)

Other: Aerobic Exercises

Tai Chi Exercises

EXPERIMENTAL

Tai Chi Exercises (yang 24 Postures)

Other: Tai Chi Exercises

Interventions

5 to 10 min warm up exercises than 30min bicycle exercise and 5 to 10 min cool down exercises

Aerobic Exercises

5 to 10 min warm up exercises and 30 min Tai Chi exercises and than than 5 to 10 min cool down exercises.

Tai Chi Exercises

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • post-operative CABG patients,
  • Ejection fraction \>40% were included

You may not qualify if:

  • ,3,4 scale of angina,
  • unstable congestive heart failure,
  • Substantial myocardial ischemia,
  • Cardiac arrhythmias,
  • Reopen chest after surgery,
  • Uncontrolled diabetes and hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (10)

  • Smith SC Jr, Collins A, Ferrari R, Holmes DR Jr, Logstrup S, McGhie DV, Ralston J, Sacco RL, Stam H, Taubert K, Wood DA, Zoghbi WA. Our time: a call to save preventable death from cardiovascular disease (heart disease and stroke). Circulation. 2012 Dec 4;126(23):2769-75. doi: 10.1161/CIR.0b013e318267e99f. Epub 2012 Sep 17. No abstract available.

    PMID: 22988010BACKGROUND
  • Bergheanu SC, Bodde MC, Jukema JW. Pathophysiology and treatment of atherosclerosis : Current view and future perspective on lipoprotein modification treatment. Neth Heart J. 2017 Apr;25(4):231-242. doi: 10.1007/s12471-017-0959-2.

    PMID: 28194698BACKGROUND
  • Stary HC, Chandler AB, Glagov S, Guyton JR, Insull W Jr, Rosenfeld ME, Schaffer SA, Schwartz CJ, Wagner WD, Wissler RW. A definition of initial, fatty streak, and intermediate lesions of atherosclerosis. A report from the Committee on Vascular Lesions of the Council on Arteriosclerosis, American Heart Association. Circulation. 1994 May;89(5):2462-78. doi: 10.1161/01.cir.89.5.2462.

    PMID: 8181179BACKGROUND
  • Centers for Disease Control and Prevention (CDC). Cigarette smoking among adults--United States, 2006. MMWR Morb Mortal Wkly Rep. 2007 Nov 9;56(44):1157-61.

    PMID: 17989644BACKGROUND
  • 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
  • Gielen S, Hambrecht R. Effects of exercise training on vascular function and myocardial perfusion. Cardiol Clin. 2001 Aug;19(3):357-68. doi: 10.1016/s0733-8651(05)70222-8.

    PMID: 11570110BACKGROUND
  • Villella M, Villella A. Exercise and cardiovascular diseases. Kidney Blood Press Res. 2014;39(2-3):147-53. doi: 10.1159/000355790. Epub 2014 Jul 29.

    PMID: 25117881BACKGROUND
  • Pattyn N, Beckers PJ, Cornelissen VA, Coeckelberghs E, De Maeyer C, Frederix G, Goetschalckx K, Possemiers N, Schepers D, Van Craenenbroeck EM, Wuyts K, Conraads VM, Vanhees L. The effect of aerobic interval training and continuous training on exercise capacity and its determinants. Acta Cardiol. 2017 Jun;72(3):328-340. doi: 10.1080/00015385.2017.1304712. Epub 2017 Mar 21.

    PMID: 28636505BACKGROUND
  • Macko RF, Ivey FM, Forrester LW, Hanley D, Sorkin JD, Katzel LI, Silver KH, Goldberg AP. Treadmill exercise rehabilitation improves ambulatory function and cardiovascular fitness in patients with chronic stroke: a randomized, controlled trial. Stroke. 2005 Oct;36(10):2206-11. doi: 10.1161/01.STR.0000181076.91805.89. Epub 2005 Sep 8.

    PMID: 16151035BACKGROUND
  • Hollings M, Mavros Y, Freeston J, Fiatarone Singh M. The effect of progressive resistance training on aerobic fitness and strength in adults with coronary heart disease: A systematic review and meta-analysis of randomised controlled trials. Eur J Prev Cardiol. 2017 Aug;24(12):1242-1259. doi: 10.1177/2047487317713329. Epub 2017 Jun 5.

    PMID: 28578612BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sumaiyah Obaid Baig, MSNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 27, 2019

Study Start

February 20, 2018

Primary Completion

June 20, 2018

Study Completion

July 5, 2018

Last Updated

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations