Effect of Phase I Cardiac Rehab With or Without Upper Limb Cycle Ergometer

Official title

Effects of Phase I Cardiac Rehabilitation With and Without Upper Limb Cycle Ergometer in Immediate Post-Operative Period of CABG

Overview

The aim of the study is to investigate the effects of an upper limb cycle ergometer in phase I CABG patients. This will likely enhance various outcomes such as quality of life, dyspnea, functional outcome measure, cardiovascular parameters, and upper limb mobility. If utilized, the arm ergometer may contribute to improve upper limb strength and endurance. This could result in improving upper limb range of motion and reducing the risk of adhesive capsulitis. This study will positively impact society by reducing morbidity and mortality rates, healthcare costs and ultimately improves patient care.

Detailed description

The most often done major surgical surgery is coronary artery bypass grafting (CABG), a significant surgical procedure by using harvested venous or arterial conduit to bypass atheromatous obstructions in a patient's coronary arteries. Following heart surgery, patients face many complications that increases the duration of stay in the intensive care unit (ICU) and hospital, as well as the death rates following surgery. Following coronary artery bypass grafting (CABG), compliance with the cardiac rehabilitation (CR) regimen is essential. Cardiac rehabilitation in phase I include mobilization, respiratory and physical exercises, education on heart disease risk factors, and stress and anxiety management. An apparatus designed to help physiotherapists to increase muscle training is the upper limb cycle ergometer. It is possible to execute cyclical rotations with this equipment and utilize it for resistive, active, and passive patient exercise. Patients who have had coronary artery bypass surgery report improved physical and psychosocial functioning after engaging in arm ergometer workouts. The aim of this study is to investigate the effects of phase I cardiac rehabilitation on quality of life, dyspnea, functional outcome measure and cardiovascular parameters with and without upper limb cycle ergometer in immediate post-operative period of CABG.

A randomized clinical trial will be conducted at Combined Military Hospital Lahore. Non-probability convenient sampling technique will be applied on the patients according to the inclusion criteria. Patient will be randomly allocated through lottery method into group A and group B to collect data. Group A will receive upper limb exercise on arm ergometer lasting 5 min at 30 rpm (rotation per minute) 3 times a day for 7 days and standard treatment which includes breathing exercises, active upper and lower exercises (3 sets of 10 repetitions daily for 7 days); ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30 min), that will be progressed as patient condition till 7th day. Group B will receive same standard treatment as above, but without arm ergometer. The study will be completed within the time duration of ten months. Treatment evaluation of patients will be done after one week through 36-Item Short Form Survey (SF-36), Modified Medical Research Council Dyspnea scale, and Functional Independence Measure scale. Data will be analyzed using SPSS software version 27. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Interventions

• Other upper limb exercise with arm ergometer
  upper limb exercise on arm ergometer lasting 5 min at 30 rpm (Rotation per minute) 3 times a day for 7 days and standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day
• Other upper limb exercise with out arm ergometer
  standard treatment which includes breathing exercises (3 sets of 10 repetitions daily for 7 days); active upper and lower exercises (3 sets of 10 repetitions daily for 7 days) with bed inclined at 45°; ambulation within the inpatient wards for 6 min, transfer to chair (allocated at the side of bed sitting for 30min), that will be progressed as patient condition till 7th day

Primary outcome measures

• Functional independence Measure (FIM) [Time frame: 7 days]
• 36- Item Short Form Survey Instrument [Time frame: 7 days]
• Modified Medical Research Council (MMRC) Dyspnea Scale [Time frame: 7 days]

Secondary outcome measures (4)

• Heart Rate (HR) [Time frame: 7 days]
• Respiratory Rate (RR) [Time frame: 7 Days]
• Blood Pressure (BP) [Time frame: 7 Days]
• Oxygen Saturation [Time frame: 7 Days]

Eligibility criteria

Inclusion criteria

• Planned CABG patients
• 40-65 years
• Both male and female
• Hemodynamic stable patients
• Post extubation

Exclusion criteria

• Patients suffering from pulmonary diseases and thyroid disorders
• Mechanical ventilation more than 24 hr
• Mean arterial pressure i.e, < 60 mmHg or > 140 mmHg and heart rate not more than 120bpm
• Having an orthopedic condition that makes the use of upper and lower extremity impossible.
• Who have neurological impairment influencing breathing rate and heart rate.
• Who required the implantation of an intra-aortic balloon during surgery
• Who experienced postoperative complications such as pulmonary embolism

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Pakistan · 1 center

• Gulab Devi Hospital — Lahore

Publications

• Organization WH. Cardiovascular diseases (CVDs). 2021.
• Bachar BJ, Manna B. Coronary Artery Bypass Graft. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507836/ PMID 29939613
• Alexander JH, Smith PK. Coronary-Artery Bypass Grafting. N Engl J Med. 2016 Sep 8;375(10):e22. doi: 10.1056/NEJMc1608042. No abstract available. PMID 27602683
• Dimopoulos S, Raidou V, Elaiopoulos D, Chatzivasiloglou F, Markantonaki D, Lyberopoulou E, Vasileiadis I, Marathias K, Nanas S, Karabinis A. Sonographic muscle mass assessment in patients after cardiac surgery. World J Cardiol. 2020 Jul 26;12(7):351-361. doi: 10.4330/wjc.v12.i7.351. PMID 32843937
• Cordeiro ALL, Mascarenhas HC, Landerson L, Araujo JDS, Borges DL, Melo TA, Guimaraes A, Petto J. Inspiratory Muscle Training Based on Anaerobic Threshold on the Functional Capacity of Patients After Coronary Artery Bypass Grafting: Clinical Trial. Braz J Cardiovasc Surg. 2020 Dec 1;35(6):942-949. doi: 10.21470/1678-9741-2019-0448. PMID 33113311
• Hossein Pour AH, Gholami M, Saki M, Birjandi M. The effect of inspiratory muscle training on fatigue and dyspnea in patients with heart failure: A randomized, controlled trial. Jpn J Nurs Sci. 2020 Apr;17(2):e12290. doi: 10.1111/jjns.12290. Epub 2019 Aug 19. PMID 31429207

Identifiers

NCT: NCT07128849 · REC/RCR & AHS/24/0351

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗