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Pre-Habilitation Exercise Intervention

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ClinicalTrials.gov Identifier: NCT02849717
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Fergal Fleming, 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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Colon Cancer Rectal Cancer Diverticular Disease Behavioral: Exercise for Cancer Patients Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pre-Habilitation Exercise Intervention for Patients Scheduled for Colorectal Surgical Resection
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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 Name: EXCAP




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849717


Contacts
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Contact: Ila Marianetti, BA ila_marianetti@urmc.rochester.edu
Contact: Ann Colasurdo, BS 585-276-4059 ann_colasurdo@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Fergal Fleming, MD    585-273-2727    fergal_fleming@urmc.rochester.edu   
Contact: Ila Marianetti, BA       ila_marianetti@urmc.rochester.edu   
Principal Investigator: Fergal Fleming, MD         
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Fergal Fleming, MD University of Rochester

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Responsible Party: Fergal Fleming, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02849717     History of Changes
Other Study ID Numbers: 59142
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Diverticular Diseases
Diverticulum
Inflammatory Bowel Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Gastroenteritis
Intraabdominal Infections
Infection
Pathological Conditions, Anatomical