Pre-Habilitation Exercise Intervention

University of Rochester82 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Inflammatory Bowel Diseases Colon Cancer Rectal Cancer Diverticular Disease

Interventions

Exercise for Cancer PatientsBEHAVIORAL

a standardized, daily, home-based, progressive exercise program

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Rochester

Rochester, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 12 weeks

Skeletal Muscle Mass will be assessed using CT assessment of muscle mass

Time frame: 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.

Data from ClinicalTrials.gov

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