Effects of Conditioning Exercises and Resistance Interval Training on Post CABG Patients.

February 24, 2025 updated by: Riphah International University

Comparison Between Conditioning Exercises and Resistance Interval Training on Quality of Life, Cardiorespiratory Fitness and Endurance in Post-CABG Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The randomized clinical trial will be conducted in physical therapy department at the District Headquarters (DHQ) in Gujranwala, employing a non-probability convenience sampling technique. The study aims to include individuals aged 40-55 years. Participants in phase IV cardiac rehabilitation. Both female and male will be included.Exclusion criteria involve individuals with another clinical trial involving physical protocols. Regular practice of physical exercise of more than 150min per week in last 3 months. Decompensated heart failure. Further exclusions encompass individuals who have had an acute myocardial infarction or cardiac surgery within the last 6 months, severe valvular heart diseases, uncontrolled cardiac arrhythmias, asymmetric septal hypertrophic cardiomyopathy with dynamic obstruction in the outflow pathway, musculoskeletal disorders limiting completion of the exercise program, and impaired cognitive status affecting understanding and adherence to the study protocol. Group A will be given a Conditioning exercise protocol while the other Group B will be given resistance interval training. The difference in improvement before and after 6 weeks will be documented and compared.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Gujrānwāla, Punjab, Pakistan, 52250
        • Cheema Heart complex, Hospital Gujranwala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Conditioning Exercise Group
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
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.
Experimental: Resistance Interval Training 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. The difference in improvement before and after 6 weeks will be documented and compared.
Other: Resistance Interval Training
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
SF-36 Questionnaire
Time Frame: 6 weeks
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
Time Frame: 6 weeks
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
Time Frame: 6 Weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qurat ul Ain, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/24/0322 Rubab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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