Pre-Habilitation Exercise Intervention

NCT ID: NCT02849717

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2023-02-28

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Diseases Colon Cancer Rectal Cancer Diverticular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Care

Subjects are advised to maintain their normal level of activity

Group Type NO_INTERVENTION

No interventions assigned to this group

Home-Based Exercise

Progressive walking and resistance exercise treatment

Group Type ACTIVE_COMPARATOR

Exercise for Cancer Patients

Intervention Type BEHAVIORAL

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

Interventions

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Exercise for Cancer Patients

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

Intervention Type BEHAVIORAL

Other Intervention Names

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EXCAP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Fergal Fleming

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fergal Fleming, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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59142

Identifier Type: -

Identifier Source: org_study_id

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