NCT02849717

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

6.9 years

First QC Date

July 19, 2016

Last Update Submit

May 15, 2023

Conditions

Inflammatory Bowel DiseasesColon CancerRectal CancerDiverticular Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (7)

  • Aerobic Capacity via VO2 maximum testing

    12 weeks

  • Skeletal Muscle Mass will be assessed using bio-electrical impedance assessment of muscle mass

    12 weeks

  • Skeletal Muscle Mass will be assessed using CT assessment of muscle mass

    12 weeks

  • Circulating Levels of Pro-Inflammatory Cytokines will be measured by standard Complete Blood Count (CBC) differential procedures.

    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.

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Standard Care

NO INTERVENTION

Subjects are advised to maintain their normal level of activity

Home-Based Exercise

ACTIVE COMPARATOR

Progressive walking and resistance exercise treatment

Behavioral: Exercise for Cancer Patients

Interventions

Exercise for Cancer PatientsBEHAVIORAL

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

Also known as: EXCAP
Home-Based Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColonic NeoplasmsRectal NeoplasmsDiverticular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsColonic DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Fergal Fleming, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 29, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

US(1)