Pre-Habilitation Exercise Intervention

May 15, 2023 updated by: Fergal Fleming, University of Rochester

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
Subjects are advised to maintain their normal level of activity
Active Comparator: Home-Based Exercise
Progressive walking and resistance exercise treatment
Behavioral: Exercise for Cancer Patients
a standardized, daily, home-based, progressive exercise program
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..
Time Frame: 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.
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Fergal Fleming, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 26, 2016

First Posted (Estimate)

July 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 59142

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammatory Bowel Diseases

Clinical Trials on Exercise for Cancer Patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe