Colon Cancer, Diverticular Disease, Inflammatory Bowel Diseases, Rectal Cancer
Conditions
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.
Interventions
BEHAVIORALExercise for Cancer Patients
a standardized, daily, home-based, progressive exercise program
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure for this study is fatigue assessed by the FACIT-F fatigue subscale.. | 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
| Measure | Time frame | Description |
|---|---|---|
| Skeletal Muscle Mass will be assessed using bio-electrical impedance assessment of muscle mass | 12 weeks | The secondary aim is to provide preliminary data on the influence of a home-based aerobic and resistance exercise (EXCAP) intervention on skeletal muscle mass and its relationship to fatigue in subjects who have undergone colorectal resection. |
| Skeletal Muscle Mass will be assessed using CT assessment of muscle mass | 12 weeks | The secondary aim is to provide preliminary data on the influence of a home-based aerobic and resistance exercise (EXCAP) intervention on skeletal muscle mass and its relationship to fatigue in subjects who have undergone colorectal resection. |
| Circulating Levels of Pro-Inflammatory Cytokines will be measured by standard Complete Blood Count (CBC) differential procedures. | 12 weeks | The secondary aim is to provide preliminary data on the influence of a home-based aerobic and resistance exercise intervention (EXCAP) plus standard care versus standard care alone on the circulating levels of pro-inflammatory cytokines (IL-6, IL-8,IL-10, IL-1B,and IFN-y) and TNFr1 cytokine receptor expression in subjects who have undergone colorectal resection. |
| Aerobic Capacity via VO2 maximum testing | 12 weeks | The secondary aim is to provide preliminary data on the influence of a home-based walking and progressive resistance exercise program (EXCAP) plus standard care versus standard care alone on aerobic capacity in subjects who have undergone colorectal resection. |
| Quality of Life (QOL) on self reported psychological distress questionnaires: Profile of Mood States (POMS). | 12 weeks | The secondary aim is to provide preliminary data on the influence of a home-based walking and progressive resistance exercise program (EXCAP) plus standard care versus standard care alone on quality of life (QOL) in subjects who have undergone colorectal resection. |
| Quality of Life (QOL) on self reported psychological distress questionnaires: Spielberg State/Trait Anxiety Inventory (STAI Form Y-1). | 12 weeks | The secondary aim is to provide preliminary data on the influence of a home-based walking and progressive resistance exercise program (EXCAP) plus standard care versus standard care alone on quality of life (QOL) in subjects who have undergone colorectal resection. |
| 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 | The secondary aim is to provide preliminary data on the influence of a home-based walking and progressive resistance exercise program (EXCAP) plus standard care versus standard care alone on post-operative complications in subjects who have undergone colorectal resection. |
Countries
United States
Outcome results
None listed