Clinical trial NCT04993976: Prehabilitation and Coronary Artery Bypass Grafting
Official title: Effects of Resistance Training in Mild to Moderate Clinically Frail Patients Awaiting Coronary Artery Bypass Graft.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Graft
Keywords: CABG
Fraility
Prehabilitation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of Prehabilitation Resistance training on frailty and functional capacity in mild to moderate clinically frail patients awaiting Coronary Artery Bypass Grafting) CABG. This study will contribute to describing the effect of resistance training in mild to moderate frails patients and were directed to be the part of cardiac rehabilitation and define the effects of cardiac prehabilitation and to check whether the effects of resistance training or routine training is similar for quality of recovery in mild to moderate frails patients which undergone CABG.

Detailed description: In literature, Coronary Artery Bypass Graft (CABG) is a form of heart surgery that redirects blood around clogged arteries to increase blood flow and oxygen to the heart. During CABG surgery, the surgeon uses a portion of a healthy vessel (either an artery or vein) from the leg, chest, or arm to create a bypass around the clogged artery. During CABG surgery with cardiopulmonary bypass, a heart-lung machine artificially maintains circulation blood and oxygenation while the surgeon operates on the heart. It includes exercise, lifestyle changes, education, and emotional support. It can help improve patient's health and enable them to live a more active life after the patient has had a heart attack or heart surgery or if the patient has long-term heart problems such as heart failure.

The time spent waiting for cardiac surgery to be scheduled is a period of great uncertainty for a patient. There appears to be heightened anxiety regarding the inclusion of physical activity in this time period, mainly as a result of their current cardiac condition or diagnosis

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective primary isolated coronary artery bypass grafting,

  * Patients with double and triple-vessel coronary artery disease.
  * Mild to moderately frail patients with a clinical frailty score of 5 -6 at the time of accepting surgery at the outpatient cardiothoracic surgical clinic.

Exclusion Criteria:

* Patient with musculoskeletal disability and neurological disability affecting respiratory rate.

  * Patient with renal dysfunction requiring dialysis, use of immunosuppressive treatments during the 30-day period before surgery,
  * Left ventricular ejection fraction \<30%
  * concomitant valve disease
  * Patient having dysrhythmias or pacemaker dependent
  * Those patients who are severely frail (CFS 7-9)

Primary outcomes:
measure: Frailty
timeFrame: 8 weeks
Secondary outcomes:
measure: Functional capacity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Faisalabad Institute of Cardiology.
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MSPT(CPPT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Afilalo J, Lauck S, Kim DH, Lefevre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, Genereux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7.
citation: Sepehri A, Beggs T, Hassan A, Rigatto C, Shaw-Daigle C, Tangri N, Arora RC. The impact of frailty on outcomes after cardiac surgery: a systematic review. J Thorac Cardiovasc Surg. 2014 Dec;148(6):3110-7. doi: 10.1016/j.jtcvs.2014.07.087. Epub 2014 Aug 7.
citation: Stammers AN, Kehler DS, Afilalo J, Avery LJ, Bagshaw SM, Grocott HP, Legare JF, Logsetty S, Metge C, Nguyen T, Rockwood K, Sareen J, Sawatzky JA, Tangri N, Giacomantonio N, Hassan A, Duhamel TA, Arora RC. Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial. BMJ Open. 2015 Mar 9;5(3):e007250. doi: 10.1136/bmjopen-2014-007250.
citation: Afilalo J, Kim S, O'Brien S, Brennan JM, Edwards FH, Mack MJ, McClurken JB, Cleveland JC Jr, Smith PK, Shahian DM, Alexander KP. Gait Speed and Operative Mortality in Older Adults Following Cardiac Surgery. JAMA Cardiol. 2016 Jun 1;1(3):314-21. doi: 10.1001/jamacardio.2016.0316.