The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000526370
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
11/04/2017
Date last updated
19/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Unique Approach to Exercise in Patients with Inflammatory Bowel Disease - A Pilot Study
Scientific title
Multi-dimensional Approach to Increase Exercise Compliance in Patients with Inflammatory Bowel Disease (IBD) - A Pilot Study
Secondary ID [1] 291641 0
None
Universal Trial Number (UTN)
U1111-1192-2859
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 302778 0
Exercise Compliance 302779 0
Fatigue 302780 0
Depression 302782 0
Anxiety 302783 0
Condition category
Condition code
Oral and Gastrointestinal 302286 302286 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 302287 302287 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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,
Intervention code [1] 297730 0
Treatment: Other
Intervention code [2] 297731 0
Lifestyle
Intervention code [3] 297732 0
Behaviour
Comparator / control treatment
Active Control - Multi-Dimensional Personalised Exercise Programme:
The intervention is as described above but participants do not have access to the one month of the supervised exercise sessions.
Personalisation - As described above
Adherence - As described above
Control group
Active

Outcomes
Primary outcome [1] 301701 0
Level of compliance of the participants to the exercise programme.
This will be assessed through the use of a goal chart that participants will fill out weekly listing their exercise carried out for the week.
Timepoint [1] 301701 0
at the end of the intervention (four months)
Secondary outcome [1] 333600 0
Inflammatory Bowel Disease disease activity scores (as measured via the Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index)
Timepoint [1] 333600 0
Baseline, end of intervention (four months), 6 and 12 months after intervention
Secondary outcome [2] 333603 0
Quality of life as assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [2] 333603 0
Baseline, end of intervention (four months), 6 and 12 months after the end of the intervention
Secondary outcome [3] 333605 0
Fatigue as assessed by the Multidimensional Fatigue Inventory (MFI) and Inflammatory Bowel Disease Fatigue Self-assessment scale (IBD-F)
Timepoint [3] 333605 0
Baseline, end of the intervention (four months), 6 and 12 months after the end of the intervention
Secondary outcome [4] 333607 0
Anxiety and depression levels as assessed by the Hospital Anxiety and Depression Scale (HADS)
Timepoint [4] 333607 0
Baseline, end of the intervention (four months), 6 and 12 months after the end of the intervention
Secondary outcome [5] 333609 0
Adverse events occurring to participants including exercise induced injury. This will be assessed through participants contact with the study should they experience any injuries while exercising. Study investigators will also be notified of any participants who might be hospitalised.
Timepoint [5] 333609 0
End of intervention (four months)
Secondary outcome [6] 333610 0
Microbiota profile of participants through a stool sample
Timepoint [6] 333610 0
Baseline and at the end of the intervention
Secondary outcome [7] 333611 0
Metabolic profile as assessed through urine sample
Timepoint [7] 333611 0
Baseline, at the end of the intervention (four months)

Eligibility
Key inclusion criteria
Patients diagnosed with mild-moderately active eInflammatory Bowel Disease (IBD) or disease in remission
Age >18 years
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The study is a pilot study so will aim to recruit at least 100 people, 50 in each arm. With a pessimistic 60% retention rate will still provide 30 participants with full data in each group. Therefore calculations on standard deviations for compliance and other outcome measures (including fatigue and QoL) for each group separately can be carried out as unequal variances are considered likely. This number will also allow us to estimate correlations between baseline and follow-up values for the secondary outcomes with sufficient confidence. This number of participants is also expected to provide sufficient feedback about the intervention itself.

The statistical programme SPSS will be used to provide a descriptive analysis for the study patients. SPSS analytical tests of Mann-Whitney U tests, Spearman’s test, Kruskal Wallis test and Pearson Chi-square test will be used where applicable to examine the relationships and correlation between study variables.

Intention to treat analysis will be carried out for the study. A P-value of <0.05 will be considered to determine a significant correlation.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8784 0
New Zealand
State/province [1] 8784 0
Otago

Funding & Sponsors
Funding source category [1] 296135 0
Other Collaborative groups
Name [1] 296135 0
Gut Health Network
Address [1] 296135 0
Dunedin Public Hospital
201 Great King Street
Dunedin, 9054
Country [1] 296135 0
New Zealand
Primary sponsor type
University
Name
Department of Medicine, University of Otago
Address
9th Floor
Dunedin Public Hospital
201 Great King street
Dunedin, 9054
Country
New Zealand
Secondary sponsor category [1] 295039 0
None
Name [1] 295039 0
Address [1] 295039 0
Country [1] 295039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297387 0
Health and Disability Ethics Committee
Ethics committee address [1] 297387 0
Ministry of Health
Health and Disability Ethics Committee
PO Box 5013
Wellington 6140
Ethics committee country [1] 297387 0
New Zealand
Date submitted for ethics approval [1] 297387 0
16/03/2017
Approval date [1] 297387 0
10/05/2017
Ethics approval number [1] 297387 0
17/NTB/44

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73886 0
A/Prof Michael Schultz
Address 73886 0
9th Floor
Dunedin Public Hopsital
201 Great King Street
Dunedin, 9054
Country 73886 0
New Zealand
Phone 73886 0
+64 3 474 0999
Fax 73886 0
Email 73886 0
Michael.Schultz@otago.ac.nz
Contact person for public queries
Name 73887 0
Miss Georgina Fagan
Address 73887 0
9th Floor
Dunedin Public Hopsital
201 Great King Street
Dunedin, 9054
Country 73887 0
New Zealand
Phone 73887 0
+64 21 130 7578
Fax 73887 0
Email 73887 0
Exercise.dunedin@gmail.com
Contact person for scientific queries
Name 73888 0
Miss Georgina Fagan
Address 73888 0
9th Floor
Dunedin Public Hopsital
201 Great King Street
Dunedin, 9054
Country 73888 0
New Zealand
Phone 73888 0
+64 21 130 7578
Fax 73888 0
Email 73888 0
Exercise.dunedin@gmail.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary