NCT06844591

Brief Summary

Coronary artery disease (CAD) is a global health challenge influenced by diabetes, hypertension, and psychosocial stress, with women having a higher prevalence of Coronary microvascular disease. Promoting coronary collateral circulation offers an alternative coronary artery disease CAD treatment. Invasive interventions like PCI and CABG aim to enhance coronary flow, restoring blood flow to ischemic myocardium. Post-CABG challenges include depression, anxiety, and factors affecting quality of life. Physiotherapy impacts heart rate variability, with virtual reality physiotherapy reducing both heart rate variability and hospital stay. Cardiac rehabilitation involves lifestyle changes, enhancing functional capacity, and supporting early recovery. Pre-operative respiratory muscle training improves outcomes. Acute high-intensity interval exercise and mild continuous exercise benefit exercise recovery. This research compares conditioning exercises and resistance interval training effects on post-CABG patients' well-being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

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

Timeline
Completed

Started Mar 2024

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

March 9, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 20, 2025

Last Update Submit

February 24, 2025

Conditions

Keywords

Coronary Artery Bypass GraftingConditioning TherapyQuality of LifeResistance Training.

Outcome Measures

Primary Outcomes (3)

  • SF-36 Questionnaire

    The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that is often used for quality of life, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life. The 36-Item Short Form Survey (SF-36) will be used which is a self-reported measure of health that covers eight domains of health.

    6 weeks

  • 6-minute walk test

    The 6-minute walk test (6MWT) will be used for cardiorespiratory fitness, to measure the distance walked in a specified time and reflect the functional exercise level. The primary measurement is 6-min walk distance (6MWD), but during the 6MWT data can also be collected about the patient's blood oxygen saturation and perception of dyspnea during exertion. When conducting the 6MWT do not walk with the patient and do not assist the patient in carrying or pulling his or her supplemental oxygen. The patient should walk alone, not with other patients. Do not use a treadmill on which the patient adjusts the speed and/or the slope. Do not use an oval or circular track. An increase in the distance walked indicates improvement in basic mobility. Post training a difference of at least 45m should be observed for the 6 minutes' walk test to be sure that a "real" change in the patient's condition

    6 weeks

  • 30-second stand chair

    For endurance, the sit-to-stand (STS) test measures the number of times a person can stand up from a chair in a given time (30 seconds, 1 minute, or 5 repetitions). The 30 Second Sit to Stand Test is also known as 30 Second Chair Stand Test (30CST), was initially designed for testing leg strength and endurance in adults. The score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand).The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre- determined number of repetitions.

    6 Weeks

Study Arms (2)

Conditioning Exercise Group

EXPERIMENTAL

Aerobic interval training (AIT), which included rest intervals in between sessions of aerobic activity on a stationary bike and treadmill, was administered to the control group. A 10-minute warm-up, or a maximum of 50% to 60% of HR, preceded the program. Participants will complete a well-tested Performa. Basic parameters will be collected through the outcome measure tool. The difference in improvement before and after 6 weeks will be documented and compared.

Other: Conditioning Exercises/ Aerobic Interval Training

Resistance Interval Training Group

EXPERIMENTAL

Resistance interval training for post-coronary artery bypass grafting (CABG) patients requires careful consideration and should be conducted under the supervision of healthcare professionals, such as cardiac rehabilitation specialists or physiotherapists. Exercise programs for individuals recovering from cardiac surgery must be tailored to their specific needs, taking into account their overall health, medical history, and current fitness level. Before beginning any exercise program, it's essential to obtain clearance from a healthcare provider. The workout lasted thirty to forty minutes in total. To fit the training load, resistance and intensity were gradually raised. For six weeks, this supervised training program was adhered to three times a week on alternate days. The difference in improvement before and after 6 weeks will be documented and compared.

Other: Resistance Interval Training

Interventions

Aerobic interval training (AIT), which included rest intervals in between sessions of aerobic activity on a stationary bike and treadmill, was administered to the control group. A 10-minute warm-up, or a maximum of 50% to 60% of HR, preceded the program. The next activity round consisted of six x six-minute intervals of cycling and walking/uphill running on a treadmill at 60% to 85% of THR, separated by three minutes of rest/recovery. A ten-to fifteen-minute cool- down period followed the session.

Conditioning Exercise Group

Resistance interval training for post-coronary artery bypass grafting (CABG) patients requires careful consideration and should be conducted under the supervision of healthcare professionals, such as cardiac rehabilitation specialists or physiotherapists. Exercise programs for individuals recovering from cardiac surgery must be tailored to their specific needs, taking into account their overall health, medical history, and current fitness level. Before beginning any exercise program, it's essential to obtain clearance from a healthcare provider. The workout lasted thirty to forty minutes in total. To fit the training load, resistance and intensity were gradually raised. For six weeks, this supervised training program was adhered to three times a week on alternate days

Resistance Interval Training Group

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 40-55 years
  • post-coronary artery bypass graft (CABG) patients both females and males were included
  • New York Heart Association criteria IV
  • Hemodynamically stable patient

You may not qualify if:

  • Fall in New York Heart Association criteria II III;
  • Hemoglobin \< 9 g/dL;
  • Patients with peripheral or vascular problems of the lower limb,
  • Cognitive and/or mental disorders;
  • Exercise limiting comorbidities (primarily orthopedic, neurological condition)
  • Enrollment in another clinical trial involving physical training protocols.
  • Not willing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheema Heart complex, Hospital Gujranwala

Gujranwala, Punjab Province, 52250, Pakistan

Location

Related Publications (5)

  • Terada T, Cotie L, Noda T, Vidal-Almela S, O'Neill CD, Reed JL. Effects of High-Intensity Interval Training, Moderate-to-Vigorous Intensity Continuous Training, and Nordic Walking on Functional Fitness in Patients with Coronary Artery Disease. J Cardiopulm Rehabil Prev. 2023 May 1;43(3):224-226. doi: 10.1097/HCR.0000000000000775. Epub 2023 Mar 2. No abstract available.

    PMID: 36857093BACKGROUND
  • Kambic T, Bozic Mijovski M, Jug B, Hadzic V, Lainscak M. Anabolic and Inflammatory Response to High- and Low-Load Resistance Training in Patients with Coronary Artery Disease: A Randomized Controlled Trial. J Cardiopulm Rehabil Prev. 2023 Jul 1;43(4):307-309. doi: 10.1097/HCR.0000000000000783. Epub 2023 Mar 6. No abstract available.

    PMID: 36867715BACKGROUND
  • McGregor G, Powell R, Begg B, Birkett ST, Nichols S, Ennis S, McGuire S, Prosser J, Fiassam O, Hee SW, Hamborg T, Banerjee P, Hartfiel N, Charles JM, Edwards RT, Drane A, Ali D, Osman F, He H, Lachlan T, Haykowsky MJ, Ingle L, Shave R. High-intensity interval training in cardiac rehabilitation: a multi-centre randomized controlled trial. Eur J Prev Cardiol. 2023 Jul 12;30(9):745-755. doi: 10.1093/eurjpc/zwad039.

    PMID: 36753063BACKGROUND
  • Rengo JL, Savage PD, Hirashima F, Leavitt BJ, Ades PA, Toth MJ. Assessment of the Early Disabling Effects of Coronary Artery Bypass Graft Surgery Using Direct Measures of Physical Function. J Cardiopulm Rehabil Prev. 2022 Jan 1;42(1):28-33. doi: 10.1097/HCR.0000000000000587.

    PMID: 33797459BACKGROUND
  • Kristiansen J, Sjuretharson T, Grove EL, Rasmussen J, Kristensen SD, Hvas AM, Mohr M. Feasibility and impact of whole-body high-intensity interval training in patients with stable coronary artery disease: a randomised controlled trial. Sci Rep. 2022 Oct 14;12(1):17295. doi: 10.1038/s41598-022-21655-w.

    PMID: 36241898BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Qurat ul Ain

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will complete a well-tested Performa. Basic parameters will be collected through the outcome measure tool. Group A will be given a Conditioning exercise protocol while the other Group B will be given resistance interval training for 6 weeks. The difference in improvement before and after 6 weeks will be documented and compared.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

March 9, 2024

Primary Completion

May 30, 2024

Study Completion

January 15, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations