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Completed

NCT Number: NCT02849717

Pre-Habilitation Exercise Intervention

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Diverticular Disease Diverticular Diseases Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise for Cancer Patients

Behavioral

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

Other names: EXCAP

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2016
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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