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

Effects of a Supervised Versus Non-supervised Exercise Program on Adherence and Functional Outcomes in Colorectal Cancer Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02586701
Enrollment
134
Registered
2015-10-26
Start date
2013-09-30
Completion date
2016-12-31
Last updated
2018-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

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.

Detailed 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.

Interventions

OTHERPrehabilitation Plus

Supervised exercise program and home-based exercise program.

Sponsors

Franco Carli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
45 Years to 90 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Six Minute Walk Test (6MWT)up to 8 weeks after surgeryChange in functional walking capacity will be assessed throughout the study according to the 6-Minute Walk Test (6MWT). The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six-minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026