An interventional study of Exercise for Cancer Patients in Inflammatory Bowel Diseases, Colon Cancer and Rectal Cancer, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by University of Rochester · Not applicable, Interventional, and Supportive care
Among 463 studies in Inflammatory Bowel Diseases with a site in United States — 103 open to participants now, 124 under way, 6 of them phase 3. Inflammatory Bowel Diseases · United States.
Among the 463 studies in Inflammatory Bowel Diseases with a site in United States, this one is the 118th largest by enrollment of the 327 interventional ones, is one of 24 that started in 2016, is one of 131 with no phase, and was the 196th registered.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's enrollment of 82 is above the median of 68 across 870 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →103 of the 463 studies in Inflammatory Bowel Diseases with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 278 Inflammatory Bowel Diseases studies recruiting now, 133 (48%) set no upper age limit and 118 (42%) stop at 75 or younger; 76 take children under 18; 61 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →463 studies; the count open now beside each. This study's row is marked.
First in 1995; this study’s year is marked. 24 started in 2016.
Median enrollment 50 across the 327 interventional studies, 134 across the 132 observational. Of the 301 that completed or were terminated, 120 (40%) have results posted.
132 of 463 have an industry lead sponsor. The 10 most frequent:
University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
University of Rochester has 2 studies filed under Inflammatory Bowel Diseases — fewer than ten, so there is no comparison to draw.
42 of the studies in Inflammatory Bowel Diseases with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05923073Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease | 2027-10-27 |
| NCT01962415Paul SzabolcsReduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT | 2026-11 |
| NCT07769437University Hospitals Cleveland Medical CenterNon-nutritive Sweeteners in Inflammatory Bowel Disease | 2026-12 |
| NCT06065228Children's National Research InstituteTherapeutic Endpoint in Pediatric IBD Conditions | 2026-12 |
| NCT04508088Massachusetts General HospitalSkeletal Health and Bone Marrow Composition in Newly Diagnosed Adolescents With Crohn Disease | 2026-12 |
Among the 463 studies in Inflammatory Bowel Diseases with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects are advised to maintain their normal level of activity
Progressive walking and resistance exercise treatment
Behavioral: Exercise for Cancer Patients
a standardized, daily, home-based, progressive exercise program
Also known as: EXCAP
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 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.
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
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
The record gives a start of Mar 2016, a primary completion of Feb 2023 and a completion of Feb 2023. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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