- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04615481
Elliptical Training Versus Ergo-meter on Cardiopulmonary Parameters in Post CABG Patients
Effects of Elliptical Training Versus Ergo-meter on Cardiopulmonary Parameters in Post CABG Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Worldwide, physiotherapists treat patients with CAD in the acute stage following a coronary event and/ or following coronary artery bypass graft (CABG) surgery. These patients are then later followed up as outpatients during cardiac rehabilitation(CR) in turn to improve cardio-respiratory fitness and quality of life and to delay the incidence of subsequent coronary events. Early mobilisation and physical activity is often the first choice of treatment, but evidence as to the optimal intensity, timing and choice of exercises is scarce. In 2018 the effect of obesity on functional capacity, anxiety and Daily life activities in patients with coronary artery disease and phase II cardiac rehabilitation. The results shows that When Group 1 patients were assessed at the end of 30 sessions of cardiac rehabilitation (CR) program, a statistically significant improvement was detected in 6MWT, physical functioning, physical role, mental health, social functioning and pain sub parameters.
In 2019, study Changes in 6-minute walk test (6MWT) distance and heart rate walking speed index following a cardiovascular prevention and rehabilitation programme .Patients increased their 6-minute walk test distance by 40 meters and decreased their heart rate walking speed index by 2.7, which translates into a saving of three heart beats for every 100 meters walked or 45 heart beats for every mile walked.
In 2012, conducted study Resistance and Balance Training Improves Functional Capacity in Very Old Participants Attending Cardiac Rehabilitation Participants were assigned randomly in a ratio of 1:1 to an intervention group (IG; inpatient CR plus resistance training and balance training) or control group (CG;inpatient CR)after Coronary Bypass Surgery. The study concluded that there is significantly greater improvement in functional capacity measured as 6-MWD,TUG time, and maximal relative workload in the IG than in the CG..
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Rawalpindi Institute of Cardiology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- CABG patients (after 4 months) undergone phase 2 rehabilitation.
Exclusion Criteria:
- Vitally Unstable patients
- Presence of arrhythmias
- History of unstable angina in last 3 months
- Intracavitary thrombus
- Recent thrombophlebitis with or without pulmonary embolism
- Sever/e obstructive cardiomyopathies
- Uncontrolled diabetes
- Severe orthopaedic problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Elliptical Training Group
Total 30 minutes of elliptical cross training, including warm up, progressive elliptical training and cool down.
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The training program will be consisted of total 30 minutes of elliptical cross training (5 minutes warm up + Progressive Training up to 20 minutes of elliptical cross training + 5 minutes cool down) for 3 days in a week for 4 weeks at an average intensity of 50-70% the maximal heart rate according to ACSM guidelines.
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Experimental: Ergo-metric Training Group
Total 30 minutes of ergometric training
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The training program will be consisted of total 30 minutes of ergometric training (5 minutes warm up + Progressive Training up to 10 minutes of upper limb ergometric training + Progressive Training up to 10 minutes of lower limb ergometric training+5 minutes cool down) for 3 days in a week for 4 weeks at an average intensity of 50-70% the maximal heart rate according to ACSM guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Borg Scale of Perceived Exertion
Time Frame: 4th week
|
Changes from the Baseline, It is a subjective numeric scale ranging from 0 to 10, where 0 indicates "no dyspnea" and 10 indicates "unbearable dyspnea."
A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
|
4th week
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Systolic and diastolic blood pressure
Time Frame: 4th week
|
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
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4th week
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6 min walk test: Distance (meters)
Time Frame: 4th week
|
Changes from the baseline, 6 min walk test was used to measure Functional capacity.
It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.
|
4th week
|
Oxygen Saturation (SpO2)
Time Frame: 4th week
|
Changes from baseline SPO2 was measured in percentage.
Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood.
Pulse oximeter measure it.
|
4th week
|
Pulse Rate
Time Frame: 4th week
|
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
|
4th week
|
WHO_BREF questioner (Quality of life)
Time Frame: 4th week
|
Changes for the baseline, The World Health Organization (WHO) Quality of Life Group Developed a self-report 26 item questionnaire called the WHO Quality of Life Instrument, Short Form (WHOQOLBREF).the
questioner is intend to assess the four aspect of quality of life physical (seven questions), psychological (six questions), social (three questions), and environmental (eight questions) dimensions.There are no cut-off points above or below which quality of life could be evaluated as "poor" or "good".
Thus, it was decided to rationalize the analysis by defining two groups at the extremes, both in perception of QoL and satisfaction with health (good QoL /satisfied - includes those who reported having good or very good QoL and were satisfied or very satisfied with their health; and poor QoL /dissatisfied - includes those who reported poor or very poor QoL and who were dissatisfied or very dissatisfied with their health).
|
4th week
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ab Manap N, Khalid KBMKM, Alias MNBA, Jamaludin NB. Quality of Life among Post Acute Myocardial Infarction Patient. ILKKM Journal of Medical and Health Sciences. 2019;1(1):20-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00712 Shafaq Wadood
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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