Pre-Habilitation Exercise Intervention

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases; Rectal Cancer; Diverticular Disease; Colon Cancer
• Interventions: Behavioral: Exercise for Cancer Patients

• Registration Number: NCT02849717
• Lead Sponsor: University of Rochester

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-29
• Primary Completion: 2023-02
• Study Completion: 2023-02
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-Based Exercise	Exercise for Cancer Patients	Progressive walking and resistance exercise treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States