None listed
Conditions
Brief summary
The overall objective of this study is to assess if a multidimensional approach to an exercise intervention – including education about goal setting/resetting, how to exercise and a personalised exercise programme – achieves high levels of physical activity compliance in patients with Inflammatory Bowel Disease (IBD) Secondary objectives are to investigate differences in fatigue levels, quality of life, depression and anxiety scores and disease activity after the intervention. Finally, we want to analyse any changes that occur to our participants’ microbiota & metabolic profile in their faeces and urine during the exercise intervention. This study is a prospective, two arm cohort study involving of patients over the age of 18 with mild-moderate active IBD or disease in remission. Patients will be recruited through postal invitation letters as well as gastroenterology outpatient clinics. Those with severe active disease, who have a physical disability that would limit their ability to exercise, those who are significantly physically active, have had recent surgery or are currently pregnant will be unable to participate in the study. At baseline participants will be asked to complete questionnaires on disease activity, fatigue levels, quality of life, current levels of physical activity and depression and anxiety levels. They will also be asked to complete a blood test, stool samples and urine sample. Once enrolled in the study, participants will have the option of choosing which group they will go into: 1. One month supervised physical activity in a group setting with the student followed by three months unsupervised physical activity. 2. Four months unsupervised physical activity. Participants will receive their personalised exercise booklet, goal chart and gold stars to be used over the next four months. Each participant will be encouraged to carry out a minimum of 5 sessions of activity a week of varying lengths and activities based on their personalised program. At the end of the four months, all participants will be asked to complete baseline testing again including questionnaires, blood, stool and urine samples.
Interventions
Supervised Multi-Dimensional Personalised Exercise Programme:
The intervention will be delivered individually by the participant themselves using information provided in the exercise booklet.. Participants will be asked to carry out five exercise sessions a week for 4 months of varying lengths and intensities based on their personalised programme. The programme will be done in the community of the participant. Participants have a choice of which arm of the study they would like to enter - either
Supervised Multi-Dimensional Personalised Exercise Programme: The intervention will be delivered individually by the participant themselves using information provided in the exercise booklet.. Participants will be asked to carry out five exercise sessions a week for 4 months of varying lengths and intensities based on their personalised programme. The programme will be done in the community of the participant. Participants have a choice of which arm of the study they would like to enter - either the intervention of the control group. Participants will have the option of attending one month of supervised exercise sessions with one of the study investigators at the start of their four month exercise intervention. These sessions are optional and will be held twice a day (morning/evening), 7 days a week. The goal of these exercise sessions is to create a supportive environment where participants can learn new skills for exercising, discuss their exercise programme or talk to others with Inflammatory Bowel Disease experiencing similar problems to them. Participants will recieve a personalised exercise booklet, weekly goal planner and gold stars. The personalised exercise booklet was developed following collaboration between a medical student, a sport and exercise medicine specialist and a clinical psychologist and contains information on how participants can create their exercise programme, solutions to common problems experienced by patients with IBD, information on how to goal set/reset and about how to carry out exercise such as walking, deep water running and high intensity interval training. The types of exercises that might be preformed include walking, running, interval training, deep water running or yoga. Participants have the choice of which exercise type they will do for the study based on what they like and enjoy doing. Personalisation - The exercise programme is personalised for each participant. This begins with the participant completing an exercise questionnaire about how often they exercise, their preferred types of exercise and how long they believe that they can carry out each exercise type for. This information will then be entered into their exercise programme. These answers will be the starting point for the participants and they will increase the amount of exercise weekly provided they feel capable. The exercise sessions will usually be increased by ~5-10 minutes a session. Adherence - Adherence to the exercise programme will be measured as the number of sessions participants completed during the four months compared to total assumed (5 sessions for 4 months = 80 sessions). Participants will complete on their weekly goal chart if they completed their exercise programme thereby allowing us to measure it,
Sponsors
Department of Medicine, University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients diagnosed with mild-moderately active eInflammatory Bowel Disease (IBD) or disease in remission Age >18 years
Exclusion criteria
Severe active IBD (as defined as HBI >16 or SCCAI > 10) Contraindication to exercise or a medical condition that may affect participants' ability to participate in exercise such as severe iron deficiency anaemia Physical disability precluding physical activity High levels of physical activity at baseline (defined using international physical activity questionnaire) Surgery in the past 1 month Currently pregnant
Outcome results
None listed