A Multidisciplinary Approach to Assessing and Treating Fatigue in Inflammatory Bowel Disease

NCT05906043 | Unknown

• 1 other identifier: RS22-038
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study is examining fatigue in patients with Inflammatory Bowel Disease (IBD). IBD includes Ulcerative Colitis (UC) and Crohn's disease. These are inflammatory conditions of the gastrointestinal tract and are associated with symptoms including diarrhoea, rectal bleeding and abdominal pain. Fatigue is a common problem for patents with IBD, affecting 80% of patients with active disease.This study aims to identify all IBD patients with fatigue. Initially, the investigators will address all medical causes of fatigue in line with current practice, using a stepwise approach (e.g. assessing for and treating active inflammation, anaemia as well as electrolyte, hormone and vitamin imbalances). The aim is to treat fatigue using a detailed algorithm, as fatigue is often a consequence of multiple issues in IBD patients. The investigators will assess the role of physical activity, nutritional status and psychological wellbeing in fatigue persisting in medically-optimised IBD patients. In addition, the contribution of the microbiome to fatigue will be assessed. For those in whom these factors are identified alongside persistent fatigue, interventions have been designed to address these factors and the resulting fatigue.

Conditions

Inflammatory Bowel Diseases; Fatigue

Outcome Measures

Primary Outcomes (1)

• Fatigue

  The primary outcome is to assess for improvement in fatigue using the Multidimensional Fatigue Index (MFI). This is a 20 item scale; each item is scored 1 to 5 with higher scores indicating higher levels of fatigue. Total score for each participant will range between 20 and 100; with high scores indicating more fatigue.

  Dependent on the factors involved; this will be different for each participant (up to 24 months)

Secondary Outcomes (17)

• Physical activity

  Intervention will take place over 12 weeks

• Work Productivity and Activity Impairment

  Intervention will take place over 12 weeks

• Physical activity: Grip strength

  Intervention will take place over 12 weeks

• Physical activity: Power assessment

  Intervention will take place over 12 weeks

• Physical activity: endurance assessment

  Intervention will take place over 12 weeks

Study Arms (7)

Cross Sectional Study to define the extent and severity of fatigue

NO INTERVENTION

All patients attending the IBD service that meet inclusion criteria will be given the opportunity to participate in this study. Information will be collected at baseline including demographic data, IBD history and symptoms, co-morbidities and disease activity. Patients will have baseline blood tests taken to assess for causes of fatigue as well as faecal calprotectin to assess for evidence of inflammation. Patients without fatigue will at this point exit the study and will not require any further follow up.

Treatment for active disease and its effect on fatigue.

NO INTERVENTION

A longitudinal study of contemporary treatment for active disease and its effect on fatigue. Patients with active disease and fatigue will be followed prospectively while undergoing treatment for active IBD with the IBD team. If their fatigue resolves, they will exit the study at this point. If their fatigue persists, they will be further assessed as detailed below.

The effect of treating anaemia on fatigue in IBD

NO INTERVENTION

A longitudinal study assessing anaemia and the effect of treatment on fatigue in those subjects with inactive IBD.Patients with anaemia and fatigue will be followed prospectively while undergoing treatment for anaemia with the IBD team. The study outcomes will be assessed at recruitment and when their anaemia has resolved (this may occur in parallel with the disease activity arm). If their fatigue resolves, they will exit the study at this point. If their fatigue persists, they will be further assessed as detailed below.

Assessing exercise therapies in IBD subjects with fatigue

OTHER

A longitudinal study assessing of dietary and exercise therapies for IBD subjects with fatigue using a single case study (SCS) design. They will have their physical activity levels assessed at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. Those with fatigue despite optimisation will be offered a physical activity intervention. Each participant will be assessed initially and subsequently assigned a physical activity intervention with a physical therapist.

Behavioral: Exercise Intervention

Acceptance and commitment therapy (ACT) in IBD subjects with fatigue

OTHER

A longitudinal study of acceptance and commitment therapy (ACT) in IBD subjects with psychological disability and fatigue using a single case study (SCS) design. All patients will undergo psychological assessment as detailed above at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. Those with fatigue and psychological disability will be referred to the IBD psychology service or recruited to a psychological intervention. Participants will receive an online intervention with a psychologist from the School of Psychology in University College Dublin to address psychological disability and associated fatigue.

Behavioral: Acceptance and Commitment Therapy

ACT for IBD subjects with sleep disturbance and fatigue

OTHER

A longitudinal study of ACT for IBD subjects with sleep disturbance using a single case study (SCS) design. Patients will have their sleep quality assessed at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. Those with sleep disturbance will undergo sleep studies at home both at the start and end of the intervention. This device will be a non-invasive, widely available sleep device worn on the wrist or the patient's index finger for one to three consecutive nights. They will be referred to the sleep medicine unit in SVUH if sleep apnea or another diagnosis that requires medical intervention is identified. Otherwise they will undergo an online intervention with a psychologist from the School of Psychology in University College Dublin to address their sleep quality.

Behavioral: Acceptance and Commitment Therapy

A longitudinal study of probiotics for IBD subjects with fatigue

OTHER

Participants will have their stool analysed to assess the diversity of their microbiome. They will receive a twelve-week course of a probiotic which will be taken once daily. They will then have their stool re-assessed at the completion of the intervention.

Dietary Supplement: Probiotic

Interventions

Exercise Intervention BEHAVIORAL

Exercise intervention

Assessing exercise therapies in IBD subjects with fatigue

Acceptance and Commitment Therapy BEHAVIORAL

ACT will be used for patients with psychological disability as well as for those with sleep disturbance

ACT for IBD subjects with sleep disturbance and fatigue; Acceptance and commitment therapy (ACT) in IBD subjects with fatigue

Probiotic DIETARY_SUPPLEMENT

Use of a probiotic

A longitudinal study of probiotics for IBD subjects with fatigue

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of inflammatory bowel disease

You may not qualify if:

• Pregnant women
• Patients unable to consent
• Patients under 18 and over 70 years of age

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

St Vincent's University Hospital

Dublin, Ireland

RECRUITING

Related Publications (11)

• Villoria A, Garcia V, Dosal A, Moreno L, Montserrat A, Figuerola A, Horta D, Calvet X, Ramirez-Lazaro MJ. Fatigue in out-patients with inflammatory bowel disease: Prevalence and predictive factors. PLoS One. 2017 Jul 27;12(7):e0181435. doi: 10.1371/journal.pone.0181435. eCollection 2017.

  PMID: 28749985 BACKGROUND

• Minderhoud IM, Samsom M, Oldenburg B. Crohn's disease, fatigue, and infliximab: is there a role for cytokines in the pathogenesis of fatigue? World J Gastroenterol. 2007 Apr 14;13(14):2089-93. doi: 10.3748/wjg.v13.i14.2089.

  PMID: 17465453 BACKGROUND

• van Langenberg DR, Gibson PR. Systematic review: fatigue in inflammatory bowel disease. Aliment Pharmacol Ther. 2010 Jul;32(2):131-43. doi: 10.1111/j.1365-2036.2010.04347.x. Epub 2010 May 6.

  PMID: 20456309 BACKGROUND

• Jelsness-Jorgensen LP, Bernklev T, Henriksen M, Torp R, Moum BA. Chronic fatigue is more prevalent in patients with inflammatory bowel disease than in healthy controls. Inflamm Bowel Dis. 2011 Jul;17(7):1564-72. doi: 10.1002/ibd.21530. Epub 2010 Nov 8.

  PMID: 21674713 BACKGROUND

• Grimstad T, Norheim KB, Isaksen K, Leitao K, Hetta AK, Carlsen A, Karlsen LN, Skoie IM, Goransson L, Harboe E, Aabakken L, Omdal R. Fatigue in Newly Diagnosed Inflammatory Bowel Disease. J Crohns Colitis. 2015 Sep;9(9):725-30. doi: 10.1093/ecco-jcc/jjv091. Epub 2015 May 19.

  PMID: 25994356 BACKGROUND

• Borren NZ, van der Woude CJ, Ananthakrishnan AN. Fatigue in IBD: epidemiology, pathophysiology and management. Nat Rev Gastroenterol Hepatol. 2019 Apr;16(4):247-259. doi: 10.1038/s41575-018-0091-9.

  PMID: 30531816 BACKGROUND

• Cohen BL, Zoega H, Shah SA, Leleiko N, Lidofsky S, Bright R, Flowers N, Law M, Moniz H, Merrick M, Sands BE. Fatigue is highly associated with poor health-related quality of life, disability and depression in newly-diagnosed patients with inflammatory bowel disease, independent of disease activity. Aliment Pharmacol Ther. 2014 Apr;39(8):811-22. doi: 10.1111/apt.12659. Epub 2014 Feb 20.

  PMID: 24612278 BACKGROUND

• Jelsness-Jorgensen LP, Bernklev T, Henriksen M, Torp R, Moum BA. Chronic fatigue is associated with impaired health-related quality of life in inflammatory bowel disease. Aliment Pharmacol Ther. 2011 Jan;33(1):106-14. doi: 10.1111/j.1365-2036.2010.04498.x. Epub 2010 Oct 25.

  PMID: 21083587 BACKGROUND

• Romberg-Camps MJ, Bol Y, Dagnelie PC, Hesselink-van de Kruijs MA, Kester AD, Engels LG, van Deursen C, Hameeteman WH, Pierik M, Wolters F, Russel MG, Stockbrugger RW. Fatigue and health-related quality of life in inflammatory bowel disease: results from a population-based study in the Netherlands: the IBD-South Limburg cohort. Inflamm Bowel Dis. 2010 Dec;16(12):2137-47. doi: 10.1002/ibd.21285.

  PMID: 20848468 BACKGROUND

• van Gennep S, de Boer NKH, Gielen ME, Rietdijk ST, Gecse KB, Ponsioen CY, Duijvestein M, D'Haens GR, Lowenberg M, de Boer AGEM. Impaired Quality of Working Life in Inflammatory Bowel Disease Patients. Dig Dis Sci. 2021 Sep;66(9):2916-2924. doi: 10.1007/s10620-020-06647-y. Epub 2020 Oct 16.

  PMID: 33063191 BACKGROUND

• Nocerino A, Nguyen A, Agrawal M, Mone A, Lakhani K, Swaminath A. Fatigue in Inflammatory Bowel Diseases: Etiologies and Management. Adv Ther. 2020 Jan;37(1):97-112. doi: 10.1007/s12325-019-01151-w. Epub 2019 Nov 23.

  PMID: 31760611 BACKGROUND

Related Links

• Crohn's \& Colitis Foundation. 2022. IBD and Fatigue.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Fatigue

Interventions

Acceptance and Commitment Therapy; Probiotics

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hugh Mulcahy, MD FRCPI

  St Vincent's University Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne M Fennessy, MB BCh BAO

CONTACT

0035312214711; anne.fennessy@ucdconnect.ie

Hugh Mulcahy, MD FRCPI

CONTACT

0035312214711; hemulc@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Hugh Mulcahy, FRCPI MD

Model Details: Cross sectional study, with observational elements and four interventions utilising a single case experimental design

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 15, 2023
• Study Start: June 20, 2023
• Primary Completion: June 24, 2025
• Study Completion: August 24, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)