Back to resultsPre-Habilitation Exercise Intervention
Primary Purpose
Inflammatory Bowel Diseases, Colon Cancer, Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise for Cancer Patients
Sponsored by
About this trial
This is an interventional supportive care trial for Inflammatory Bowel Diseases
Eligibility Criteria
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
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard Care
Home-Based Exercise
Arm Description
Subjects are advised to maintain their normal level of activity
Progressive walking and resistance exercise treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02849717
Brief Title
Pre-Habilitation Exercise Intervention
Official Title
Pre-Habilitation Exercise Intervention for Patients Scheduled for Colorectal Surgical Resection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 2023 (Actual)
Study Completion Date
February 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Colon Cancer, Rectal Cancer, Diverticular Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Subjects are advised to maintain their normal level of activity
Arm Title
Home-Based Exercise
Arm Type
Active Comparator
Arm Description
Progressive walking and resistance exercise treatment
Intervention Type
Behavioral
Intervention Name(s)
Exercise for Cancer Patients
Other Intervention Name(s)
EXCAP
Intervention Description
a standardized, daily, home-based, progressive exercise program
Primary Outcome Measure Information:
Title
The primary outcome measure for this study is fatigue assessed by the FACIT-F fatigue subscale..
Description
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 Outcome Measure Information:
Title
Aerobic Capacity via VO2 maximum testing
Description
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
Title
Skeletal Muscle Mass will be assessed using bio-electrical impedance assessment of muscle mass
Description
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
Title
Skeletal Muscle Mass will be assessed using CT assessment of muscle mass
Description
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
Title
Circulating Levels of Pro-Inflammatory Cytokines will be measured by standard Complete Blood Count (CBC) differential procedures.
Description
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.
Time Frame
12 weeks
Title
Post-operative Complications will be extracted from patient charts and will be classified for severity using the Clavien-Dindo classification of surgical complications.
Description
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.
Time Frame
12 weeks
Title
Quality of Life (QOL) on self reported psychological distress questionnaires: Profile of Mood States (POMS).
Description
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.
Time Frame
12 weeks
Title
Quality of Life (QOL) on self reported psychological distress questionnaires: Spielberg State/Trait Anxiety Inventory (STAI Form Y-1).
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fergal Fleming, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
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Pre-Habilitation Exercise Intervention
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