NCT05174754

Brief Summary

The investigators propose the use of a 20 week physician-derived exercise programme will lead to an improvement in physical fitness which will in turn lead to an increase in muscle mass, a reduction in visceral obesity resulting in an improvement in biologic response, disease biomarkers (including a reduction in circulating pro-inflammatory cytokines), fatigue scores and quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

August 30, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2023

Completed
Last Updated

November 1, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

November 8, 2021

Last Update Submit

October 27, 2022

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (3)

  • The recruitment rates in both IBD arms.

    A calculation of the percentage of people approached who participate in the intervention (recruitment).

    26 weeks

  • The retention rate in both IBD arms.

    A calculation of the percentage of people approached who complete the intervention.

    26 weeks

  • The adherence rate in both IBD arms.

    A calculation of the percentage of people approached who adhered to the intervention.

    26 weeks

Secondary Outcomes (12)

  • Change in muscle mass measured by ultrasound

    26 weeks

  • Change in muscle mass measured by bioelectrical impedance analysis

    26 weeks

  • Change in visceral fat measured by bioelectrical impedance analysis

    26 weeks

  • Clinical remission in response to exercise intervention

    12 and 26 weeks

  • Change in fatigue score between the IBD groups in response to exercise

    12 and 26 weeks

  • +7 more secondary outcomes

Other Outcomes (2)

  • Measurement of metabolic markers in response to exercise

    12 and 26 weeks

  • Adverse events

    26 weeks

Study Arms (3)

Inflammatory Bowel Disease Exercise Group

EXPERIMENTAL

The exercise group will be randomized to a 20-week physician-prescribed exercise programme following the principles of Frequency, Intensity, Time, and Type (FITT) in addition to best medical therapy with the aim of increasing physical fitness levels, inflammatory response, quality of life/fatigue improvements and favorable body composition changes.

Behavioral: Physician-prescribed Exercise ProgrammeDrug: Best Medical Therapy

Inflammatory Bowel Disease Control Group

OTHER

The IBD control group will be randomized to best medical therapy alone.

Drug: Best Medical Therapy

Healthy Control Group

NO INTERVENTION

A group of healthy controls without inflammatory bowel disease will be included in the study for comparison of inflammatory markers including cytokine analysis and body composition.

Interventions

Physician-prescribed Exercise ProgrammeBEHAVIORAL

A 20-week structured exercise programme derived and supervised by a Sports Medicine Physician following the FITT Principles

Inflammatory Bowel Disease Exercise Group
Best Medical TherapyDRUG

Best medical therapy with biologic agent or small-molecule therapy

Inflammatory Bowel Disease Control GroupInflammatory Bowel Disease Exercise Group

Eligibility Criteria

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

You may qualify if:

  • years of age or above.
  • Confirmed moderate to severe inflammatory bowel disease based on endoscopic evaluation, clinical scoring tools and faecal calprotectin.
  • Be able to provide written informed consent.
  • Stable dose of steroids.
  • Physically able to complete an exercise programme.
  • Healthy controls.

You may not qualify if:

  • Inability to participate in the exercise program (unable to perform 6MWT, unable to attend for assessment of parameters at any time point).
  • An uncontrolled cardiovascular condition such as unstable angina, uncontrolled cardiac arrhythmias, uncontrolled symptomatic heart failure or symptomatic severe aortic stenosis.
  • A significant musculoskeletal condition, neurological condition, mental illness or intellectual disability that restricts participation in a physical exercise program.
  • Pregnancy.
  • Healthy controls with underlying inflammatory conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Hospital

Dublin, Ireland

RECRUITING

Related Publications (12)

  • Elia J, Kane S. Adult Inflammatory Bowel Disease, Physical Rehabilitation, and Structured Exercise. Inflamm Bowel Dis. 2018 Nov 29;24(12):2543-2549. doi: 10.1093/ibd/izy199.

    PMID: 29850914BACKGROUND

  • Chan D, Robbins H, Rogers S, Clark S, Poullis A. Inflammatory bowel disease and exercise: results of a Crohn's and Colitis UK survey. Frontline Gastroenterol. 2014 Jan;5(1):44-48. doi: 10.1136/flgastro-2013-100339. Epub 2013 Jul 31.

    PMID: 28839750BACKGROUND

  • Cronin O, Barton W, Moran C, Sheehan D, Whiston R, Nugent H, McCarthy Y, Molloy CB, O'Sullivan O, Cotter PD, Molloy MG, Shanahan F. Moderate-intensity aerobic and resistance exercise is safe and favorably influences body composition in patients with quiescent Inflammatory Bowel Disease: a randomized controlled cross-over trial. BMC Gastroenterol. 2019 Feb 12;19(1):29. doi: 10.1186/s12876-019-0952-x.

    PMID: 30755154BACKGROUND

  • Eckert KG, Abbasi-Neureither I, Koppel M, Huber G. Structured physical activity interventions as a complementary therapy for patients with inflammatory bowel disease - a scoping review and practical implications. BMC Gastroenterol. 2019 Jul 2;19(1):115. doi: 10.1186/s12876-019-1034-9.

    PMID: 31266461BACKGROUND

  • Gatt K, Schembri J, Katsanos KH, Christodoulou D, Karmiris K, Kopylov U, Pontas C, Koutroubakis IE, Foteinogiannopoulou K, Fabian A, Molnar T, Zammit D, Fragaki M, Balomenos D, Zingboim N, Ben Horin S, Mantzaris GJ, Ellul P. Inflammatory Bowel Disease [IBD] and Physical Activity: A Study on the Impact of Diagnosis on the Level of Exercise Amongst Patients With IBD. J Crohns Colitis. 2019 May 27;13(6):686-692. doi: 10.1093/ecco-jcc/jjy214.

    PMID: 30561568BACKGROUND

  • Jones K, Baker K, Speight RA, Thompson NP, Tew GA. Randomised clinical trial: combined impact and resistance training in adults with stable Crohn's disease. Aliment Pharmacol Ther. 2020 Sep;52(6):964-975. doi: 10.1111/apt.16002. Epub 2020 Jul 30.

    PMID: 33119156BACKGROUND

  • Jones PD, Kappelman MD, Martin CF, Chen W, Sandler RS, Long MD. Exercise decreases risk of future active disease in patients with inflammatory bowel disease in remission. Inflamm Bowel Dis. 2015 May;21(5):1063-71. doi: 10.1097/MIB.0000000000000333.

    PMID: 25723616BACKGROUND

  • Klare P, Nigg J, Nold J, Haller B, Krug AB, Mair S, Thoeringer CK, Christle JW, Schmid RM, Halle M, Huber W. The impact of a ten-week physical exercise program on health-related quality of life in patients with inflammatory bowel disease: a prospective randomized controlled trial. Digestion. 2015;91(3):239-47. doi: 10.1159/000371795. Epub 2015 Mar 24.

    PMID: 25823689BACKGROUND

  • Lamers CR, de Roos NM, Bongers CCWG, Ten Haaf DSM, Hartman YAW, Witteman BJM, Hopman MTE. Repeated prolonged moderate-intensity walking exercise does not appear to have harmful effects on inflammatory markers in patients with inflammatory bowel disease. Scand J Gastroenterol. 2021 Jan;56(1):30-37. doi: 10.1080/00365521.2020.1845791. Epub 2020 Nov 19.

    PMID: 33211989BACKGROUND

  • Loudon CP, Corroll V, Butcher J, Rawsthorne P, Bernstein CN. The effects of physical exercise on patients with Crohn's disease. Am J Gastroenterol. 1999 Mar;94(3):697-703. doi: 10.1111/j.1572-0241.1999.00939.x.

    PMID: 10086654BACKGROUND

  • Ng V, Millard W, Lebrun C, Howard J. Low-intensity exercise improves quality of life in patients with Crohn's disease. Clin J Sport Med. 2007 Sep;17(5):384-8. doi: 10.1097/JSM.0b013e31802b4fda.

    PMID: 17873551BACKGROUND

  • Afzal R, Dowling JK, McCoy CE. Impact of Exercise on Immunometabolism in Multiple Sclerosis. J Clin Med. 2020 Sep 21;9(9):3038. doi: 10.3390/jcm9093038.

    PMID: 32967206BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Karen Boland, PhD

    Royal College of Surgeons, Ireland and Beaumont Hospital, Dublin, Ireland.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Boland, PhD

CONTACT

018092810karenjboland@gmail.com

Neasa Mc Gettigan, MB BCh, MSc

CONTACT

018092810neasamcgettigan21@rcsi.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

January 3, 2022

Study Start

August 30, 2022

Primary Completion

March 22, 2023

Study Completion

May 22, 2023

Last Updated

November 1, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)