Clinical trial NCT02849717: Pre-Habilitation Exercise Intervention
Official title: Pre-Habilitation Exercise Intervention for Patients Scheduled for Colorectal Surgical Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Colon Cancer
Rectal Cancer
Diverticular Disease
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to see whether exercise can improve the health and well-being of patients scheduled to undergo surgery for a bowel related condition.

Detailed description: The proposed randomized controlled trial aims to recruit 60 patients that have a primary diagnosis of either colon or rectal cancer, inflammatory bowl disease, or diverticular disease and are scheduled for elective surgery. This two-arm clinical trial of an intervention examining the efficacy of a home-based walking and progressive resistance exercise program for the relief of post-operative fatigue and improvement of functional outcome following surgery.

Eligibility criteria: Inclusion Criteria:

* Have a primary diagnosis of one of the following: colon or rectal cancer, inflammatory bowel disease, or diverticular disease
* Be scheduled for elective (non- emergent) surgery
* Have the approval of their treating physician, study physician, or physician's designee to participate in maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program.
* Be able to read English (since the assessment materials will be in a printed format).
* Be 18 years of age or older
* Give informed consent.

Exclusion Criteria:

* Have physical limitations (e.g. cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in maximal physiological fitness testing, or a low to moderate home-based walking and progressive resistance program, as assessed by the Par-Q+ and clinician (or physician's designee)
* Must not be in active or maintenance stage of exercise

Primary outcomes:
measure: The primary outcome measure for this study is fatigue assessed by the FACIT-F fatigue subscale..
timeFrame: 12 weeks
Secondary outcomes:
measure: Aerobic Capacity via VO2 maximum testing
timeFrame: 12 weeks
measure: Skeletal Muscle Mass will be assessed using bio-electrical impedance assessment of muscle mass
timeFrame: 12 weeks
measure: Skeletal Muscle Mass will be assessed using CT assessment of muscle mass
timeFrame: 12 weeks
measure: Circulating Levels of Pro-Inflammatory Cytokines will be measured by standard Complete Blood Count (CBC) differential procedures.
timeFrame: 12 weeks
measure: Post-operative Complications will be extracted from patient charts and will be classified for severity using the Clavien-Dindo classification of surgical complications.
timeFrame: 12 weeks
measure: Quality of Life (QOL) on self reported psychological distress questionnaires: Profile of Mood States (POMS).
timeFrame: 12 weeks
measure: Quality of Life (QOL) on self reported psychological distress questionnaires: Spielberg State/Trait Anxiety Inventory (STAI Form Y-1).
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Fergal Fleming, MD
role: PRINCIPAL_INVESTIGATOR
References: