Effectiveness of Early Cardiac Rehabilitation

NCT06116773 | Unknown

• 1 other identifier: IUC-FTR-RC-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this experimental study is to compare the effects of early (2nd week) cardiac rehabilitation applied in addition to usual care on functional capacity, quality of life, frailty and body composition in patients undergoing coronary artery bypass graft surgery. 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

Conditions

Coronary Artery Disease

Keywords

Early Cardiac Rehabilitation; Coronary Artery Bypass Graft Surgery; Functional Capacity; Quality of Life; Frailty

Outcome Measures

Primary Outcomes (1)

• Six minute walk test (6MWT)

  Functional capacity will be evaluated with the 6-minute walk test (6MWT). Patients will be walked in a 30-meter-long corridor for 6 minutes and the maximum walking distance will be measured. Before and after the test, heart rate, blood pressure and O2 saturation will be measured with pulse oximetry, and dyspnea and fatigue levels will be determined according to the Modified Borg scale.

  eight weeks

Secondary Outcomes (8)

• Modified Borg Scale

  eight weeks

• New York Heart Association (NYHA) functional classification

  eight weeks

• Modified Medical Research Council (MMRC) dyspnea scale

  eight weeks

• Frail Scale

  eight weeks

• Short Physical Performance Battery

  eight weeks

Study Arms (2)

Training Group

EXPERIMENTAL

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.

Other: Training

Control Group

ACTIVE COMPARATOR

Control group will be informed about secondary prevention approaches and a home exercise program will be recommended.

Other: Control

Interventions

Training OTHER

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.

Training Group

Control OTHER

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.

Control Group

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ⩾65 years old patients who underwent CABG surgery in the 2nd week post-op
• No contraindications for exercise training and ability to exercise
• Patients without diagnosed cognitive impairment

You may not qualify if:

• Cardiac arrhythmias that pose a serious risk
• 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)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

RECRUITING

Related Publications (12)

• 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.

  PMID: 22064600 BACKGROUND

• 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.

  PMID: 10961975 BACKGROUND

• 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.

  PMID: 23851406 BACKGROUND

• 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.

  PMID: 32037378 BACKGROUND

• 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.

  PMID: 20482475 BACKGROUND

• 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.

  PMID: 19477380 BACKGROUND

• 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.

  PMID: 19782265 BACKGROUND

• 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.

  PMID: 26722187 BACKGROUND

• 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.

  PMID: 31504913 BACKGROUND

• 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.

  PMID: 29602750 BACKGROUND

• 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.

  PMID: 28101566 BACKGROUND

• 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.

  PMID: 35731506 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Frailty

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rengin Demir, Prof

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Raziye Ceylan, MSc

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raziye Ceylan

CONTACT

+905068825393; raziyeceylan87@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: our study was conducted as single (assessor) blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master of science

Model Details: two groups: training group and control group.

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 3, 2023
• Study Start: December 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)