Supervised Versus Non-supervised Exercise on Adherence and Functional Outcomes in Colorectal Patients

Franco Carli

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: Prehabilitation Plus

Study type: Interventional

Funder types: Other

Identifiers

NCT02586701

MM123

Details and patient eligibility

About

Investigation into prehabilitation by increasing the supervision of exercise in patients undergoing colorectal resection for cancer and comparing with patients involved in a rehabilitation group receiving exercise after surgery.

Full description

The aims of this research project are the following:

To determine to what extent a structured multimodal prehabilitation regimen, which includes aerobic and resistance exercise, nutritional supplementation and psychological coping strategies, initiated before surgery, and continued while in hospital and after surgery, optimizes the recovery of functional walking capacity following colorectal resection for cancer.

To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.

Enrollment: 134 patients

Sex: All

Ages: 45 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• referred electively for resection of malignant, non metastasized, colorectal lesions.
• French or English speaking

Exclusion criteria

• ASA class 4-5
• co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis)
• cardiac abnormalities
• severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV), COPD, renal failure (creatinine > 1.5mg/dl, and hepatic failure ALT and AST > 50% over the normal range)
• Sepsis
• Morbid obesity (BMI > 40)
• Anemia (hematocrit < 30%, haemoglobin < 10g/dl, albumin < 25mg/dl).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

Prehabilitation Plus

Active Comparator group

Description:

Patients in this group will be enrolled in a multimodal program before surgery involving supervised exercise, nutrition counseling and relaxation strategies. Supervised exercise is provided once a week for four weeks before surgery as well as during the hospital stay post surgery. Patients are to continue with a home-based exercise program for 8 weeks after discharge.

Treatment:

Other: Prehabilitation Plus

Rehabilitation

No Intervention group

Description:

Patients in this group are provided with in-hospital supervised exercises with a kinesiologist post surgery until discharge. Patients, upon discharge are provided with a home-based exercise program, nutritional counseling and relaxation strategies for 8 weeks.