Clinical trial NCT03361150: High-Intensity Interval vs. Moderate Continuous Training in Surgical Prehabilitation.
Official title: High-Intensity Interval Training Versus Moderate Continuous Training in Multimodal Prehabilitation for Colorectal Surgery: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Physical Activity
Keywords: prehabilitation
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgery is a stressful procedure associate with perioperative physical impairment. In a previous study, the investigators showed that physical fitness could be optimize in surgical patients using prehabilitation, a preoperative conditioning intervention in form of exercise, nutrition and relaxation technique. The best modality of exercise has yet to be known.The purpose of this study is to compare high interval (HIT) vs. moderate continuous intensity (MC) training, integrated in a prehabilitation intervention in colorectal surgical patients.

Detailed description: All patients will receive prehabilitation preoperatively for 4 weeks, that is composed of 3 elements, exercise, nutritional supplements and psychological coping strategies. Both exercise protocol will be supervised, 3-time per week, in-hospital programs. Patients will be randomized to perform either HIT or MC training. Exercise intensity will be defined and personalized on the individual values at cardiopulmonary exercise testing (CPET). Patients' nutritional status and dietary intake will be assessed by the nutritionist, and supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg. Perioperative care will follow the McGill Surgical Recovery Pathway, also called Enhanced Recovery Program, which is an evidence-based care plan set up by the Surgical Recovery (SuRe) multidisciplinary committee of the McGill University Health Centre.

Eligibility criteria: Inclusion Criteria:

* Subjects eligible to enter the study will include those aged 18 and above and referred electively for resection of malignant colorectal lesions.

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions interfering with the ability to perform exercise at home or to complete the testing procedures. Poor English and French comprehension.

Primary outcomes:
measure: Oxygen consumption (VO2)
timeFrame: 4 weeks (before surgery)
Secondary outcomes:
measure: Six-minute walking distance.
timeFrame: 4 weeks (before surgery)
measure: Sit-to-Stand test
timeFrame: 4 weeks (before surgery)
measure: Community Health Activities Model Program for Seniors (CHAMPS) score
timeFrame: 4 weeks (before surgery)
measure: Hospital Anxiety and Depression Scale (HADS) score
timeFrame: 4 weeks (before surgery)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
References:
citation: Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.
citation: Minnella EM, Ferreira V, Awasthi R, Charlebois P, Stein B, Liberman AS, Scheede-Bergdahl C, Morais JA, Carli F. Effect of two different pre-operative exercise training regimens before colorectal surgery on functional capacity: A randomised controlled trial. Eur J Anaesthesiol. 2020 Nov;37(11):969-978. doi: 10.1097/EJA.0000000000001215.