Response To Medical Therapy in Inflammatory Bowel Disease Patients Carrying-out a Prescribed Exercise Programme

Inflammatory Bowel Diseases Clinical Trial

Official title:

The Impact Of A Physician-led Exercise Programme On Quality Of Life, Muscle Mass And Clinical Response In Inflammatory Bowel Disease Patients During Induction With Medical Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174754
• Other study ID #: 21-048
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2022
• Est. completion date: May 22, 2023

Study information

• Verified date: February 2022
• Source: Royal College of Surgeons, Ireland
• Contact: Karen Boland, PhD
• Phone: 018092810
• Email: karenjboland[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After completion, the investigators expect to describe the significant impact that exercise has on IBD disease control, response to biologics, modification of pro-inflammatory cytokine levels, quality of life and fatigue scores.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 22, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Behavioral:
• Physician-prescribed Exercise Programme
A 20-week structured exercise programme derived and supervised by a Sports Medicine Physician following the FITT Principles

Drug:
• Best Medical Therapy
Best medical therapy with biologic agent or small-molecule therapy

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Royal College of Surgeons, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (12)

Afzal R, Dowling JK, McCoy CE. Impact of Exercise on Immunometabolism in Multiple Sclerosis. J Clin Med. 2020 Sep 21;9(9). pii: E3038. doi: 10.3390/jcm9093038. Review. — View Citation

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. — View Citation

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. — View Citation

Eckert KG, Abbasi-Neureither I, Köppel 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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of metabolic markers in response to exercise	Analysis of key immunometabolic pathways including flow cytometry of peripheral T-cells	12 and 26 weeks
Other	Adverse events	The frequency and nature of adverse events will be recorded (number, percentage and type).	26 weeks
Primary	The recruitment rates in both IBD arms.	A calculation of the percentage of people approached who participate in the intervention (recruitment).	26 weeks
Primary	The retention rate in both IBD arms.	A calculation of the percentage of people approached who complete the intervention.	26 weeks
Primary	The adherence rate in both IBD arms.	A calculation of the percentage of people approached who adhered to the intervention.	26 weeks
Secondary	Change in muscle mass measured by ultrasound	Ultrasound of thigh muscle mass (vastus intermedius and rectus femoris-measured in mm, subcutaneous adiposity measured in mm)	26 weeks
Secondary	Change in muscle mass measured by bioelectrical impedance analysis	Bioelectrical impedance analysis (muscle mass in Kg)	26 weeks
Secondary	Change in visceral fat measured by bioelectrical impedance analysis	Bioelectrical impedance analysis (visceral fat in Kg)	26 weeks
Secondary	Clinical remission in response to exercise intervention	Harvey Bradshaw Index 2 or lower in Crohn's disease patients or partial Mayo score 0-1in ulcerative colitis	12 and 26 weeks
Secondary	Change in fatigue score between the IBD groups in response to exercise	Measured using the Fatigue Severity Scale which comprises nine statements, describing the severity and impact of fatigue, with a scale of possible responses ranging from 1 ("strongly disagree") to 7 ("strongly agree").	12 and 26 weeks
Secondary	Change in Quality of Life in response to exercise	Measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)- a ten item questionnaire, with 1 to 7 points for each item and higher scores indicating higher quality of life.	12 and 26 weeks
Secondary	Change in endoscopic disease activity between IBD groups	A change in endoscopic appearance of Crohn's using Simple endoscopic score for Crohn's disease (SES CD) (inactive when SES-CD was 0-2; mild when 3-6; moderate 7-15; and severe >16) or Mayo score for ulcerative colitis (Score 0-3, Mayo 3 indicating severe disease, 2 moderate disease, 1 mild disease and 0 inactive).	26 weeks
Secondary	Inflammatory response between IBD groups measured using C-Reactive protein	Change in C-Reactive Protein (mg/L)	12 and 26 weeks
Secondary	Inflammatory response between IBD groups measured using faecal calprotectin	Change in faecal calprotectin (ug/g)	12 and 26 weeks
Secondary	Inflammatory response between IBD groups measured using pro-inflammatory cytokines	Change in circulating pro-inflammatory cytokines (pg/mL)	12 and 26 weeks
Secondary	Change in handgrip strength	Use of Jamar dynamometer to measure handgrip strength in kPa	12 and 26 weeks
Secondary	A change in physical fitness between the IBD patient arms	15% difference in 6-minute walk test (6MWT) distance between the two groups	26 weeks