Study Results
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Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-12-01
2025-12-01
Brief Summary
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The main questions it aims to answer are:
* Does early cardiac rehabilitation contribute to increasing functional capacity?
* Does early cardiac rehabilitation have positive effects on quality of life, frailty and body composition?
Participants will be divided into 2 groups (n = 50) in a randomized controlled manner. Patients in the training group (n:25) will participate in an 8-week supervised cardiac rehabilitation program as an outpatient after discharge. Patients in the control group (n:25) will be provided with usual care after discharge.
The control group will be informed about secondary prevention approaches and a home-based exercise program will be recommended. In addition to secondary prevention approaches and home-based exercise program, the training group will receive 3 sessions/week, 60 minutes of supervised cardiac rehabilitation for 8 weeks. All patients will be evaluated at baseline and after 8 weeks.
Researchers will compare training and control groups to see if effects on functional capacity, quality of life, frailty, body composition
Detailed Description
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Outpatient CR programs are designed to reduce the deconditioning negative effects of medical and surgical interventions in cardiac patients and have well-accepted health and survival benefits. CR improves exercise capacity, quality of life, and long-term prognosis in patients with coronary artery disease. The beneficial effects of cardiac rehabilitation applied to patients after CABG surgery on exercise capacity, coronary risk factors and quality of life have been documented (PubMed identification (ID): 22064600). Positive benefits of postdischarge exercise training have been demonstrated (PubMed ID: 10961975), and it seems reasonable to begin exercise training immediately after CABG surgery (PubMed ID: 23851406). A recent multicenter study showed that patients who actively participated in an outpatient CR program after CABG surgery exhibited greater improvement in exercise capacity and better survival without cardiovascular events than those who did not participate in the CR program (PubMed ID: 32037378).
Prior to this, international guidelines did not recommend resistance training as part of the CR program immediately after CABG surgery, with the rationale that physical exertion causes pressure or stress in the sternal area and should therefore be avoided for at least 6 weeks and 3 months after surgery. However, results of a published meta-analysis (PubMed ID: 20482475) suggest that resistance training is an effective exercise program to improve 6-minute walking distance in individuals with chronic heart failure.
The goals of resistance training in older adults are to increase exercise and functional capacity, reduce activity limitation, and improve functionality in performing daily activity, thereby improving social reintegration and health-related quality of life. Resistance training in older adults may increase muscle strength and endurance and thus prevent age-related loss of skeletal muscle mass and strength as well as loss of bone mass. Strength and balance are closely related and are important in improving dynamic balance and increasing strength, which helps maintain activities of daily living and prevent frailty in very old adults. Studies have been conducted to evaluate the effects of combined aerobic and resistance training on the functional capacity of patients undergoing CABG surgery. Studies (PubMed ID: 19477380, PubMed ID: 19782265) showed that combined training caused a significant improvement in peak oxygen uptake in this patient population. While CR is recommended to begin as soon as possible after discharge, enrollment typically occurs several weeks after hospital discharge. This creates a gap in rehabilitative care. Reduced physiological reserve resulting from surgery, hospitalization, and the recovery period between discharge and CR may increase the risk of postoperative complications, readmission, and physical disability. It is known that a delay in starting CR prolongs recovery, increases dependency on family/caregivers, and especially those of working age are negatively affected. Additionally, any delay may reduce the benefits of KR.
Many patients rapidly lose muscle and bone mass during sedentary periods after sternotomy, increasing the risk of falls and prolonging recovery time. Accordingly, a number of preliminary studies have shown superior results when activity is started earlier after sternotomy. (PubMed ID: 26722187, PubMed ID: 28101566, PubMed ID: 29602750, PubMed ID: 31504913). A current study also proved that starting exercise training 2 weeks after sternotomy is effective and safe (PubMed ID: 35731506 ).With this study plan, we hypothesized that comprehensive cardiac rehabilitation in the early period after CABG would increase functional capacity. The aim of our study is to investigate the effectiveness of early (2nd week) phase 2 cardiac rehabilitation compared to usual care in patients undergoing CABG surgery, based on the primary outcome of functional capacity and secondary outcomes of quality of life, frailty, and body composition. This study will be an important study investigating the effects of phase 2 cardiac rehabilitation applied in the early period (2nd week) after CABG surgery on functional capacity, quality of life, fragility and body composition.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Training Group
Training group, in addition to secondary prevention approaches and home exercise program, will be applied 3 sessions/week, 60 minutes of supervised cardiac rehabilitation program for 8 weeks.
Training
Training group is supervised exercise group and will be included in a supervised cardiac rehabilitation program for 3 days a week. The program will start 2 weeks after CABG surgery and continue for 8 weeks, totaling 24 sessions. Aerobic, resistance, balance and stretching exercises will be applied within the program. Total exercise time is aimed to be ≥150 min/week for 8 weeks. A home-based exercise program will be recommended.
Moderate-intensity continuous aerobic training will be implemented using an upright exercise bike (5 minutes warm-up, 20 minutes load, 5 minutes cool down, 5 minutes recovery). Rhythmic unloaded aerobic exercises or low-load (0.5-1 kg) resistance exercises (starting from the 6th week post-op) will be performed for an average of 15-20 minutes. Balance exercises will progress from easy to difficult depending on the person's performance. Stretching exercise for the gastrocnemius muscle will be performed for 4 repetitions in a short stretching period of 15 seconds.
Control Group
Control group will be informed about secondary prevention approaches and a home exercise program will be recommended.
Control
Patients will be informed about secondary prevention approaches which is routinely performed after discharge after CABG operation and will be recommended a home-based exercise program. Patients will be called by phone once a week and exercise monitoring will be provided. Recommended home exercise program includes:
* Breathing exercises
* Moderate intensity (RPE 4-6) walking (150 min/week).
* Posture exercises (shoulder elevation-depression, 90 degree shoulder flex-extend, 90 degree shoulder abd-add, neck joint range of motion exercises)
* They will be advised to continue range of motion exercises in the early post-operative period. (Twice a day, 10 repetitions).These exercises include ankle dorsi-plantar flexion, hip abduction-adduction, hip internal-external rotation, hip flexion-extension, arm elevation-depression in the supine position; flexion-extension in the sitting position; hip abduction-adduction, hip hyperextension and counting movements in the standing position.
Interventions
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Training
Training group is supervised exercise group and will be included in a supervised cardiac rehabilitation program for 3 days a week. The program will start 2 weeks after CABG surgery and continue for 8 weeks, totaling 24 sessions. Aerobic, resistance, balance and stretching exercises will be applied within the program. Total exercise time is aimed to be ≥150 min/week for 8 weeks. A home-based exercise program will be recommended.
Moderate-intensity continuous aerobic training will be implemented using an upright exercise bike (5 minutes warm-up, 20 minutes load, 5 minutes cool down, 5 minutes recovery). Rhythmic unloaded aerobic exercises or low-load (0.5-1 kg) resistance exercises (starting from the 6th week post-op) will be performed for an average of 15-20 minutes. Balance exercises will progress from easy to difficult depending on the person's performance. Stretching exercise for the gastrocnemius muscle will be performed for 4 repetitions in a short stretching period of 15 seconds.
Control
Patients will be informed about secondary prevention approaches which is routinely performed after discharge after CABG operation and will be recommended a home-based exercise program. Patients will be called by phone once a week and exercise monitoring will be provided. Recommended home exercise program includes:
* Breathing exercises
* Moderate intensity (RPE 4-6) walking (150 min/week).
* Posture exercises (shoulder elevation-depression, 90 degree shoulder flex-extend, 90 degree shoulder abd-add, neck joint range of motion exercises)
* They will be advised to continue range of motion exercises in the early post-operative period. (Twice a day, 10 repetitions).These exercises include ankle dorsi-plantar flexion, hip abduction-adduction, hip internal-external rotation, hip flexion-extension, arm elevation-depression in the supine position; flexion-extension in the sitting position; hip abduction-adduction, hip hyperextension and counting movements in the standing position.
Eligibility Criteria
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Inclusion Criteria
* No contraindications for exercise training and ability to exercise
* Patients without diagnosed cognitive impairment
Exclusion Criteria
* Unstable angina
* Decompensated heart failure
* Unstable blood pressure control
* Peripheral artery disease with claudication
* Severe myocardial ischemia
* Cerebrovascular disease
* Orthopedic disease
* Chronic kidney disease (creatinine \>3.0 mg/dL)
* Liver dysfunction (alanine aminotransferase \>200 U/L)
* Other serious organ failure and/or other medical causes (e.g. difficulty walking)
65 Years
95 Years
ALL
No
Sponsors
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Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Raziye Ceylan
master of science
Principal Investigators
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Rengin Demir, Prof
Role: STUDY_DIRECTOR
Istanbul University - Cerrahpasa
Raziye Ceylan, MSc
Role: PRINCIPAL_INVESTIGATOR
Istanbul University - Cerrahpasa
Locations
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Basaksehir Cam and Sakura City Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Raziye Ceylan, MSc
Role: primary
References
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Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011 Dec 6;124(23):2610-42. doi: 10.1161/CIR.0b013e31823b5fee. Epub 2011 Nov 7. No abstract available.
Balady GJ, Ades PA, Comoss P, Limacher M, Pina IL, Southard D, Williams MA, Bazzarre T. Core components of cardiac rehabilitation/secondary prevention programs: A statement for healthcare professionals from the American Heart Association and the American Association of Cardiovascular and Pulmonary Rehabilitation Writing Group. Circulation. 2000 Aug 29;102(9):1069-73. doi: 10.1161/01.cir.102.9.1069. No abstract available.
Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.
Origuchi H, Itoh H, Momomura SI, Nohara R, Daida H, Masuda T, Kohzuki M, Makita S, Ueshima K, Nagayama M, Omiya K, Adachi H, Goto Y. Active Participation in Outpatient Cardiac Rehabilitation Is Associated With Better Prognosis After Coronary Artery Bypass Graft Surgery - J-REHAB CABG Study. Circ J. 2020 Feb 25;84(3):427-435. doi: 10.1253/circj.CJ-19-0650. Epub 2020 Feb 8.
Hwang CL, Chien CL, Wu YT. Resistance training increases 6-minute walk distance in people with chronic heart failure: a systematic review. J Physiother. 2010;56(2):87-96. doi: 10.1016/s1836-9553(10)70038-2.
Onishi T, Shimada K, Sunayama S, Ohmura H, Sumide T, Masaki Y, Fukao K, Nishitani M, Kume A, Sato H, Naito H, Kawai S, Amano A, Daida H. Effects of cardiac rehabilitation in patients with metabolic syndrome after coronary artery bypass grafting. J Cardiol. 2009 Jun;53(3):381-7. doi: 10.1016/j.jjcc.2009.01.004. Epub 2009 Feb 23.
Sumide T, Shimada K, Ohmura H, Onishi T, Kawakami K, Masaki Y, Fukao K, Nishitani M, Kume A, Sato H, Sunayama S, Kawai S, Shimada A, Yamamoto T, Kikuchi K, Amano A, Daida H. Relationship between exercise tolerance and muscle strength following cardiac rehabilitation: comparison of patients after cardiac surgery and patients with myocardial infarction. J Cardiol. 2009 Oct;54(2):273-81. doi: 10.1016/j.jjcc.2009.05.016.
Adams J, Lotshaw A, Exum E, Campbell M, Spranger CB, Beveridge J, Baker S, McCray S, Bilbrey T, Shock T, Lawrence A, Hamman BL, Schussler JM. An alternative approach to prescribing sternal precautions after median sternotomy, "Keep Your Move in the Tube". Proc (Bayl Univ Med Cent). 2016 Jan;29(1):97-100. doi: 10.1080/08998280.2016.11929379.
El-Ansary D, LaPier TK, Adams J, Gach R, Triano S, Katijjahbe MA, Hirschhorn AD, Mungovan SF, Lotshaw A, Cahalin LP. An Evidence-Based Perspective on Movement and Activity Following Median Sternotomy. Phys Ther. 2019 Dec 16;99(12):1587-1601. doi: 10.1093/ptj/pzz126.
Katijjahbe MA, Granger CL, Denehy L, Royse A, Royse C, Bates R, Logie S, Nur Ayub MA, Clarke S, El-Ansary D. Standard restrictive sternal precautions and modified sternal precautions had similar effects in people after cardiac surgery via median sternotomy ('SMART' Trial): a randomised trial. J Physiother. 2018 Apr;64(2):97-106. doi: 10.1016/j.jphys.2018.02.013. Epub 2018 Mar 27.
Mungovan SF, Singh P, Gass GC, Smart NA, Hirschhorn AD. Effect of physical activity in the first five days after cardiac surgery. J Rehabil Med. 2017 Jan 19;49(1):71-77. doi: 10.2340/16501977-2165.
Ennis S, Lobley G, Worrall S, Evans B, Kimani PK, Khan A, Powell R, Banerjee P, Barker T, McGregor G. Effectiveness and Safety of Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training: The SCAR Randomized Clinical Trial. JAMA Cardiol. 2022 Aug 1;7(8):817-824. doi: 10.1001/jamacardio.2022.1651.
Other Identifiers
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IUC-FTR-RC-01
Identifier Type: -
Identifier Source: org_study_id