A Multidisciplinary Approach to Assessing and Treating Fatigue in Inflammatory Bowel Disease
NCT ID: NCT05906043
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2023-06-20
2025-08-24
Brief Summary
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Detailed Description
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There are seven elements to this study that will be carried out in parallel:
1. An initial cross-sectional study to define the extent and severity of fatigue in IBD subjects incorporating a simple fitness test protocol. 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. In those with fatigue, disease activity will be assessed and treated in accordance with current clinical guidelines (as would be standard of care). Fatigued patients will also be assessed for anaemia and other medical causes of fatigue and treated for these as per current clinical practice guidelines.
2. 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. Each patient's response to treatment will vary and so the exact time point between disease treatment and resolution of disease activity cannot be clearly defined. The study outcomes will be assessed at recruitment and when participants achieve clinical and biochemical remission. If fatigue resolves, participants will exit the study at this point. If fatigue persists, further assessments will take place as detailed below.
3. 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. Each patient's response to treatment will vary and so the exact time point between anaemia treatment and resolution of anaemia cannot be clearly defined. The study outcomes will be assessed at recruitment and when anaemia has resolved (this may occur in parallel with the disease activity arm). If fatigue resolves, participants will exit the study at this point. If fatigue persists, further assessments will take place as detailed below.
4. A longitudinal study assessing of dietary and exercise therapies for IBD subjects using a single case study (SCS) design. Participants will also have physical activity levels assessed at recruitment and as needed after active disease/anaemia/nutritional deficiencies have been adequately treated. These assessments will take place on site in St Vincent's University Hospital. If fatigue resolves, participants will exit the study at this point. Those with fatigue despite optimizing nutrition will be offered a physical activity intervention. The time interval between recruitment and resolution of micronutrient deficiencies will vary from patient to patient and so the exact time interval cannot be specified. Each participant will be assessed initially and subsequently assigned a physical activity intervention with a physical therapist designed by the Department of Sports Medicine, University College Dublin.
5. A longitudinal study of acceptance and commitment therapy (ACT) in IBD subjects with psychological disability 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 intervention with a psychologist from the School of Psychology in University College Dublin to address psychological disability and associated fatigue.
6. A longitudinal study of ACT for IBD subjects with sleep disturbance using a single case study (SCS) design. Patients will have 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. Participants will be referred to the sleep medicine unit in SVUH if sleep apnea or another diagnosis that requires medical intervention is identified. Otherwise participants will undergo an intervention with a psychologist from the School of Psychology in University College Dublin to address sleep quality.
7. A longitudinal study of probiotics for IBD subjects with fatigue. Participants will have stool samples analysed to assess the microbiome diversity. A twelve-week course of a probiotic which will be taken once daily will then be provided. Stool will be re-assessed at the completion of the intervention.
Each of the four treatment arms will be treated as multiple baseline single case experimental design (SCED). Thus, each participant is treated as an individual study. This type of study provides evidence for the effectiveness of interventions with much fewer participants than group average-based designs such as Randomized Controlled Trials. Standard group-based designs may find an overall treatment benefit on average but may underestimate risks, ineffectiveness, and benefits to the individual.
Each participant will receive a follow up phone call after the intervention is complete, to identify any challenges integrating skills discussed during the interventions. Completion of an online questionnaire will be required at the end of the study period, in order to assess the primary and secondary outcomes.
Any participants with ongoing fatigue will be able to opt to participate in the remaining treatment arms if needed.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cross Sectional Study to define the extent and severity of fatigue
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.
No interventions assigned to this group
Treatment for active disease and its effect on fatigue.
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.
No interventions assigned to this group
The effect of treating anaemia on fatigue in IBD
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.
No interventions assigned to this group
Assessing exercise therapies in IBD subjects with fatigue
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.
Exercise Intervention
Exercise intervention
Acceptance and commitment therapy (ACT) in IBD subjects with fatigue
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.
Acceptance and Commitment Therapy
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
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.
Acceptance and Commitment Therapy
ACT will be used for patients with psychological disability as well as for those with sleep disturbance
A longitudinal study of probiotics for IBD subjects with fatigue
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.
Probiotic
Use of a probiotic
Interventions
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Exercise Intervention
Exercise intervention
Acceptance and Commitment Therapy
ACT will be used for patients with psychological disability as well as for those with sleep disturbance
Probiotic
Use of a probiotic
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients unable to consent
* Patients under 18 and over 70 years of age
18 Years
70 Years
ALL
No
Sponsors
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University College Dublin
OTHER
Responsible Party
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Hugh Mulcahy
Prof. Hugh Mulcahy, FRCPI MD
Principal Investigators
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Hugh Mulcahy, MD FRCPI
Role: PRINCIPAL_INVESTIGATOR
St Vincent's University Hospital
Locations
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St Vincent's University Hospital
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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RS22-038
Identifier Type: -
Identifier Source: org_study_id
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