Home-based exercise program in major abdominal surgeries to improve exercise tolerance, which may help in better recovery.

Not yet recruiting

• Conditions: Malignant neoplasm of liver, not specified as primary or secondary,

• Registration Number: CTRI/2020/12/030009
• Lead Sponsor: Tata Memorial Centre

Brief Summary

Hepatic and pancreatic resection surgeries are thestandard of care for patients with primary or secondary hepatic and pancreatictumours. Management of thesecancers typically involves aggressive, lengthy procedures with locoregionalwith or without systemic therapy. Combination of these treatments can lead to aplethora of acute and long-term toxic effects that can, in turn, lead not onlyto considerable functional morbidity but also to an increased risk of mortality[1,2]. Cancer and its treatments related deconditioning is a serious problem.That is why physical activity recommendations for cancer patients has begun tochange.

Previousstudies have shown that though there is a declining trend of mortality postmajor abdominal surgeries, the morbidity rates are still high, ranging from Pancreas – Mortality – 1.7%, MajorMorbidity – 30%, Liver –Mortality – 3.8%, major Morbidity 19% (Our Hospital data). Studies have beendone in the past, highlighting the role of prehabilitation in reducingpostoperative complications [3,4]. Nevertheless, the precise protocol ofprehabilitation has not been completely established [5,6]. Further work isrequired to tailor optimal prehabilitation protocols for speciï¬c operativeprocedures.

Cancer-relatedfatigue is a well-known side effect of anti-cancer therapies. Exerciseinterventions have been developed to prevent or counteract fatigue withpromising results [7,8].Thus, we have planned a prehabilitation programme forpatients requiring major hepatic (≥3 segment liver resection) and pancreaticresections which includes a structured home-basedindividualized exercise training.

Though inour institute currently we are following a prehabilitation programme which alsoincludes a single session of supervised exercise training followed byunsupervised and unmonitored exercise prescription at home. **Our hypothesisis that a more structured (more supervised and monitored) individualisedexercise prescription-based program may further help in prehabilitation whichwill improve functional capacity resulting in decrease in the postoperativemorbidity and mortality.** However, such a program needs to be evaluated forits feasibility and effectiveness in patients undergoing hepatic and pancreaticresection surgeries.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-12-19
• Study Start: 2021-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

All Patients with age between 25-80 years [11] planned for major hepatic (≥3 segments) or pancreatic resection.

Exclusion Criteria

• 1.Patients requiring neoadjuvant chemotherapy 2.Any condition that prevents patients from undergoing regular exercises- locomotor limitations precluding exercise training adherence to the program.
• 3.Known case of COPD and platelet count of Ë‚ 80,000 [12] 4.Restricts patients to undergo a CPET evaluation: grade ≥3 peripheral neuropathy, a recent history (within the previous 3 months) of myocardial infarction or unstable angina, cerebrovascular event or transient ischemic attack or pulmonary embolic event, or existing acute or chronic deep vein thrombosis, or active sepsis.
• 5.Cognitive deterioration preventing adherence to the program 6.Requiring expedited surgical procedures (<5weeks time from day of decision of surgery to intended date of surgery) 7.Hemoglobin <8mg/dl.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A Change in AT (Anaerobic threshold) and VO2max by 2.	4 WEEKS

Trial Locations

Locations (1)

TATA MEMORIAL CENTRE; 🇮🇳 Mumbai, MAHARASHTRA, India

TATA MEMORIAL CENTRE

🇮🇳Mumbai, MAHARASHTRA, India

Reshma Ambulkar

Principal investigator

9821790448

rambulkar@hotmail.com