High-Intensity Interval vs. Moderate Continuous Training in Surgical Prehabilitation.

NCT ID: NCT03361150

Last Updated: 2018-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-02-28

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.

Conditions

Colorectal Cancer; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HIT

Preoperative nutrition, relaxation strategies + high intensity interval training (HIT). HIT alternates a series of high-intensity bouts with relief period. This will be a personalized, 3 times per week, 40-min exercise. Protein supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg.

Group Type: EXPERIMENTAL

HIT

Intervention Type: PROCEDURE

Both exercise protocol will be personalized, 3 times per week, 40-min exercise. HIT alternates a series of high-intensity bouts with relief period. MCT is continuous exercise with a constant intensity below anaerobic threshold.

MCT

Preoperative nutrition, relaxation strategies + high intensity interval training (MCT). MCT is continuous exercise with a constant intensity below anaerobic threshold. This will be a personalized, 3 times per week, 40-min exercise. Protein supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg.

Group Type: ACTIVE_COMPARATOR

MCT

Intervention Type: PROCEDURE

Both exercise protocol will be personalized, 3 times per week, 40-min exercise. MCT is continuous exercise with a constant intensity below anaerobic threshold.

Interventions

HIT

Both exercise protocol will be personalized, 3 times per week, 40-min exercise. HIT alternates a series of high-intensity bouts with relief period. MCT is continuous exercise with a constant intensity below anaerobic threshold.

Intervention Type: PROCEDURE

MCT

Both exercise protocol will be personalized, 3 times per week, 40-min exercise. MCT is continuous exercise with a constant intensity below anaerobic threshold.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: lead

Responsible Party

Franco Carli

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 25076007 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32976204 (View on PubMed)

Other Identifiers

15-244-MUHC

Identifier Type: -

Identifier Source: org_study_id