ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000526370

Ethics application status

Approved

Date submitted

7/04/2017

Date registered

11/04/2017

Date last updated

14/01/2021

Date data sharing statement initially provided

14/01/2021

Date results provided

14/01/2021

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]

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

Exercise Compliance

Fatigue

Depression

Anxiety

Condition category

Condition code

Oral and Gastrointestinal

Inflammatory bowel disease

Oral and Gastrointestinal

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]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

at the end of the intervention (four months)

Secondary outcome [1]

Inflammatory Bowel Disease disease activity scores (as measured via the Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index)

Timepoint [1]

Baseline, end of intervention (four months), 6 and 12 months after intervention

Secondary outcome [2]

Quality of life as assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ)

Timepoint [2]

Baseline, end of intervention (four months), 6 and 12 months after the end of the intervention

Secondary outcome [3]

Fatigue as assessed by the Multidimensional Fatigue Inventory (MFI) and Inflammatory Bowel Disease Fatigue Self-assessment scale (IBD-F)

Timepoint [3]

Baseline, end of the intervention (four months), 6 and 12 months after the end of the intervention

Secondary outcome [4]

Anxiety and depression levels as assessed by the Hospital Anxiety and Depression Scale (HADS)

Timepoint [4]

Baseline, end of the intervention (four months), 6 and 12 months after the end of the intervention

Secondary outcome [5]

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]

End of intervention (four months)

Secondary outcome [6]

Microbiota profile of participants through a stool sample

Timepoint [6]

Baseline and at the end of the intervention

Secondary outcome [7]

Metabolic profile as assessed through urine sample

Timepoint [7]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

17/04/2017

Actual

10/05/2017

Date of last participant enrolment

Anticipated

30/06/2017

Actual

9/08/2017

Date of last data collection

Anticipated

30/10/2018

Actual

9/12/2018

Sample size

Target

100

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Gut Health Network

Address [1]

Dunedin Public Hospital
201 Great King Street
Dunedin, 9054

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health 
Health and Disability Ethics Committee 
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

16/03/2017

Approval date [1]

10/05/2017

Ethics approval number [1]

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

A/Prof Michael Schultz

Address

9th Floor
Dunedin Public Hopsital
201 Great King Street
Dunedin, 9054

Country

New Zealand

Phone

+64 3 474 0999

Fax

Michael.Schultz@otago.ac.nz

Contact person for public queries

Name

Georgina Fagan

Address

9th Floor
Dunedin Public Hopsital
201 Great King Street
Dunedin, 9054

Country

New Zealand

Phone

+64 21 130 7578

Fax

Exercise.dunedin@gmail.com

Contact person for scientific queries

Name

Georgina Fagan

Address

9th Floor
Dunedin Public Hopsital
201 Great King Street
Dunedin, 9054

Country

New Zealand

Phone

+64 21 130 7578

Fax

Exercise.dunedin@gmail.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Physical Activity in Patients with Inflammatory Bowel Disease: A Cross-Sectional Study.	2021	https://dx.doi.org/10.1159/000511212

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically