Pre-Habilitation Exercise Intervention

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849717
• Other study ID #: 59142
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: February 2023

Study information

• Verified date: May 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Diverticular Disease
• Diverticulum
• Inflammatory Bowel Diseases
• Rectal Cancer

Intervention

Behavioral:
• Exercise for Cancer Patients
a standardized, daily, home-based, progressive exercise program

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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