Pre-Habilitation Exercise Intervention for Patients Scheduled for Colorectal Surgical Resection
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Inflammatory Bowel Diseases
- Sponsor
- University of Rochester
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- The primary outcome measure for this study is fatigue assessed by the FACIT-F fatigue subscale..
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Fergal Fleming
Assistant Professor
University of Rochester
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
Outcomes
Primary Outcomes
The primary outcome measure for this study is fatigue assessed by the FACIT-F fatigue subscale..
Time Frame: 12 weeks
The primary analyses will involve examination of means, standard deviations, and effect sizes of the two arms on fatigue at all three times, separately by cohort and combined.
Secondary Outcomes
- Aerobic Capacity via VO2 maximum testing(12 weeks)
- Circulating Levels of Pro-Inflammatory Cytokines will be measured by standard Complete Blood Count (CBC) differential procedures.(12 weeks)
- Post-operative Complications will be extracted from patient charts and will be classified for severity using the Clavien-Dindo classification of surgical complications.(12 weeks)
- Skeletal Muscle Mass will be assessed using bio-electrical impedance assessment of muscle mass(12 weeks)
- Skeletal Muscle Mass will be assessed using CT assessment of muscle mass(12 weeks)
- Quality of Life (QOL) on self reported psychological distress questionnaires: Profile of Mood States (POMS).(12 weeks)
- Quality of Life (QOL) on self reported psychological distress questionnaires: Spielberg State/Trait Anxiety Inventory (STAI Form Y-1).(12 weeks)