Impact of a physician-led exercise programme on quality of life, muscle mass and clinical response in inflammatory bowel disease patients during induction with disease-modifying therapy: a study protocol
Introduction Biologic and small-molecule therapies have revolutionised the treatment of moderate-to-severe inflammatory bowel disease (IBD). A significant proportion of patients experience early or delayed treatment failure. Patients with IBD with greater visceral obesity are less likely to respond...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-10-01
|
| Series: | BMJ Open Gastroenterology |
| Online Access: | https://bmjopengastro.bmj.com/content/9/1/e000959.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850100507383693312 |
|---|---|
| author | Noel McCaffrey Karen Boland Neasa Mc Gettigan Marion Hanley Fiona Skelly Jennifer Dowling Ruth Dunne Martina M Morrin Aoibhlinn O'Toole |
| author_facet | Noel McCaffrey Karen Boland Neasa Mc Gettigan Marion Hanley Fiona Skelly Jennifer Dowling Ruth Dunne Martina M Morrin Aoibhlinn O'Toole |
| author_sort | Noel McCaffrey |
| collection | DOAJ |
| description | Introduction Biologic and small-molecule therapies have revolutionised the treatment of moderate-to-severe inflammatory bowel disease (IBD). A significant proportion of patients experience early or delayed treatment failure. Patients with IBD with greater visceral obesity are less likely to respond to biologics. Sarcopenia has been identified as a predictor of disease severity and need for rescue therapy in acute severe ulcerative colitis. The aim of this study is to assess the feasibility of a physician-derived exercise programme in patients with IBD commencing biologic or small-molecule therapy in addition to the effect on physical fitness, body composition and objective measures of quality of life, fatigue scores and disease activity.Methods and analysis This is a randomised controlled feasibility study comparing the effects of a physician-derived exercise programme and standard medical care (biologic/small-molecule therapy) with standard care alone in patients with moderate to severe IBD. Patients with IBD in the intervention group will undergo a structured exercise programme for 20 weeks. Both IBD groups will carry out body composition, disease activity and quality-of-life assessments at baseline, week 12 and week 26. The primary objective is to assess the feasibility of the physician-derived exercise programme in patients with IBD commencing disease-modifying therapies. Secondary endpoints include a change in cardiorespiratory fitness, disease activity/inflammation, fatigue, health-related quality of life outcomes and body composition between the two IBD groups. Exploratory endpoints include validation of anterior thigh ultrasound for sarcopenia screening, assessment of proinflammatory cytokines and markers of immunometabolism.Ethics and dissemination This study has received ethical approval from the Beaumont Hospital Ethics committee on 22 October 2021 (reference number 21/21). Data generated or analysed during this study will be published as an article and supplementary appendix in relevant medical journals. The data will also be presented at national and international conferences.Trial registration number NCT05174754. |
| format | Article |
| id | doaj-art-313680bcced14702999bea2851dda5fd |
| institution | DOAJ |
| issn | 2054-4774 |
| language | English |
| publishDate | 2022-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Gastroenterology |
| spelling | doaj-art-313680bcced14702999bea2851dda5fd2025-08-20T02:40:17ZengBMJ Publishing GroupBMJ Open Gastroenterology2054-47742022-10-019110.1136/bmjgast-2022-000959Impact of a physician-led exercise programme on quality of life, muscle mass and clinical response in inflammatory bowel disease patients during induction with disease-modifying therapy: a study protocolNoel McCaffrey0Karen Boland1Neasa Mc Gettigan2Marion Hanley3Fiona Skelly4Jennifer Dowling5Ruth Dunne6Martina M Morrin7Aoibhlinn O'Toole8ExWell Medical, Irish Wheelchair Association, Dublin, IrelandDepartment of Gastroenterology, Beaumont Hospital, Dublin, IrelandDepartment of Gastroenterology, Beaumont Hospital, Dublin, IrelandDepartment of Radiology, Beaumont Hospital, Dublin, IrelandDepartment of Sport and Health Sciences, Technological University of the Shannon (TUS), Westmeath, IrelandDepartment of Molecular and Cellular Therapeutics, Royal College of Surgeons in Ireland, Dublin, IrelandDepartment of Radiology, Beaumont Hospital, Dublin, IrelandDepartment of Radiology, Beaumont Hospital, Dublin, IrelandDepartment of Gastroenterology, Beaumont Hospital, Dublin, IrelandIntroduction Biologic and small-molecule therapies have revolutionised the treatment of moderate-to-severe inflammatory bowel disease (IBD). A significant proportion of patients experience early or delayed treatment failure. Patients with IBD with greater visceral obesity are less likely to respond to biologics. Sarcopenia has been identified as a predictor of disease severity and need for rescue therapy in acute severe ulcerative colitis. The aim of this study is to assess the feasibility of a physician-derived exercise programme in patients with IBD commencing biologic or small-molecule therapy in addition to the effect on physical fitness, body composition and objective measures of quality of life, fatigue scores and disease activity.Methods and analysis This is a randomised controlled feasibility study comparing the effects of a physician-derived exercise programme and standard medical care (biologic/small-molecule therapy) with standard care alone in patients with moderate to severe IBD. Patients with IBD in the intervention group will undergo a structured exercise programme for 20 weeks. Both IBD groups will carry out body composition, disease activity and quality-of-life assessments at baseline, week 12 and week 26. The primary objective is to assess the feasibility of the physician-derived exercise programme in patients with IBD commencing disease-modifying therapies. Secondary endpoints include a change in cardiorespiratory fitness, disease activity/inflammation, fatigue, health-related quality of life outcomes and body composition between the two IBD groups. Exploratory endpoints include validation of anterior thigh ultrasound for sarcopenia screening, assessment of proinflammatory cytokines and markers of immunometabolism.Ethics and dissemination This study has received ethical approval from the Beaumont Hospital Ethics committee on 22 October 2021 (reference number 21/21). Data generated or analysed during this study will be published as an article and supplementary appendix in relevant medical journals. The data will also be presented at national and international conferences.Trial registration number NCT05174754.https://bmjopengastro.bmj.com/content/9/1/e000959.full |
| spellingShingle | Noel McCaffrey Karen Boland Neasa Mc Gettigan Marion Hanley Fiona Skelly Jennifer Dowling Ruth Dunne Martina M Morrin Aoibhlinn O'Toole Impact of a physician-led exercise programme on quality of life, muscle mass and clinical response in inflammatory bowel disease patients during induction with disease-modifying therapy: a study protocol BMJ Open Gastroenterology |
| title | Impact of a physician-led exercise programme on quality of life, muscle mass and clinical response in inflammatory bowel disease patients during induction with disease-modifying therapy: a study protocol |
| title_full | Impact of a physician-led exercise programme on quality of life, muscle mass and clinical response in inflammatory bowel disease patients during induction with disease-modifying therapy: a study protocol |
| title_fullStr | Impact of a physician-led exercise programme on quality of life, muscle mass and clinical response in inflammatory bowel disease patients during induction with disease-modifying therapy: a study protocol |
| title_full_unstemmed | Impact of a physician-led exercise programme on quality of life, muscle mass and clinical response in inflammatory bowel disease patients during induction with disease-modifying therapy: a study protocol |
| title_short | Impact of a physician-led exercise programme on quality of life, muscle mass and clinical response in inflammatory bowel disease patients during induction with disease-modifying therapy: a study protocol |
| title_sort | impact of a physician led exercise programme on quality of life muscle mass and clinical response in inflammatory bowel disease patients during induction with disease modifying therapy a study protocol |
| url | https://bmjopengastro.bmj.com/content/9/1/e000959.full |
| work_keys_str_mv | AT noelmccaffrey impactofaphysicianledexerciseprogrammeonqualityoflifemusclemassandclinicalresponseininflammatoryboweldiseasepatientsduringinductionwithdiseasemodifyingtherapyastudyprotocol AT karenboland impactofaphysicianledexerciseprogrammeonqualityoflifemusclemassandclinicalresponseininflammatoryboweldiseasepatientsduringinductionwithdiseasemodifyingtherapyastudyprotocol AT neasamcgettigan impactofaphysicianledexerciseprogrammeonqualityoflifemusclemassandclinicalresponseininflammatoryboweldiseasepatientsduringinductionwithdiseasemodifyingtherapyastudyprotocol AT marionhanley impactofaphysicianledexerciseprogrammeonqualityoflifemusclemassandclinicalresponseininflammatoryboweldiseasepatientsduringinductionwithdiseasemodifyingtherapyastudyprotocol AT fionaskelly impactofaphysicianledexerciseprogrammeonqualityoflifemusclemassandclinicalresponseininflammatoryboweldiseasepatientsduringinductionwithdiseasemodifyingtherapyastudyprotocol AT jenniferdowling impactofaphysicianledexerciseprogrammeonqualityoflifemusclemassandclinicalresponseininflammatoryboweldiseasepatientsduringinductionwithdiseasemodifyingtherapyastudyprotocol AT ruthdunne impactofaphysicianledexerciseprogrammeonqualityoflifemusclemassandclinicalresponseininflammatoryboweldiseasepatientsduringinductionwithdiseasemodifyingtherapyastudyprotocol AT martinammorrin impactofaphysicianledexerciseprogrammeonqualityoflifemusclemassandclinicalresponseininflammatoryboweldiseasepatientsduringinductionwithdiseasemodifyingtherapyastudyprotocol AT aoibhlinnotoole impactofaphysicianledexerciseprogrammeonqualityoflifemusclemassandclinicalresponseininflammatoryboweldiseasepatientsduringinductionwithdiseasemodifyingtherapyastudyprotocol |