Pre-Habilitation Exercise Intervention

Study 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.

Official Title
-----------------
Pre-Habilitation Exercise Intervention for Patients Scheduled for Colorectal Surgical Resection

Conditions
-----------------
Inflammatory Bowel Diseases, Colon Cancer, Rectal Cancer, Diverticular Disease

Intervention / Treatment
-----------------
* Behavioral: Exercise for Cancer Patients


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Subjects are advised to maintain their normal level of activity | |
| Active Comparator: Home-Based Exercise<br>Progressive walking and resistance exercise treatment | Behavioral: Exercise for Cancer Patients<br>* a standardized, daily, home-based, progressive exercise program<br>* Other names: EXCAP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure for this study is fatigue assessed by the FACIT-F fatigue subscale.. | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic Capacity via VO2 maximum testing | 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. | 12 weeks | 
| Skeletal Muscle Mass will be assessed using bio-electrical impedance assessment of muscle mass | 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. | 12 weeks | 
| Skeletal Muscle Mass will be assessed using CT assessment of muscle mass | 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. | 12 weeks | 
| Circulating Levels of Pro-Inflammatory Cytokines will be measured by standard Complete Blood Count (CBC) differential procedures. | 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. | 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. | 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. | 12 weeks | 
| Quality of Life (QOL) on self reported psychological distress questionnaires: Profile of Mood States (POMS). | 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. | 12 weeks | 
| Quality of Life (QOL) on self reported psychological distress questionnaires: Spielberg State/Trait Anxiety Inventory (STAI Form Y-1). | 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. | 12 weeks |