Plain English Summary
Background and study aims
Crohn’s disease (CD) is one of the main types of inflammatory bowel disease (IBD), a name given to long-term conditions which causes inflammation (swelling) in the digestive system (gut). Although it can affect any part of the gut, it is most common at the end of the ileum (the last part of the small intestine) or the colon (the large intestine). It is characterised by different phases of disease activity, alternating between remission (when the disease is not active) and flare-ups (when the disease is active and causing symptoms). Currently, there is no cure for Crohn’s disease, and so treatments tend to be geared towards ensuring the disease remains in remission. Currently, little is known about the effects of exercise in CD; however it could have several beneficial effects such as reducing fatigue and inflammation, increasing muscle and bone strength, and improving overall quality of life. The aim of this study is to look into the effects of a resistance exercise programme in people suffering from CD.
Who can participate?
People aged 16 years or older who have mildly active or inactive Crohn’s disease.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive usual care only. Those in the second group receive usual care plus a six-month resistance training programme involving a combination of supervised and unsupervised exercise sessions. Each session begins with a five-minute warm up, then approximately 45 minutes of whole-body resistance training (using body weight and elastic bands for resistance), and a three-minute cool down. At the start of the study, and then again at three and six months, participants complete a number of questionnaires and physical tests in order to find out if there has been any change to their muscle function, fatigue and quality of life. At the start of the study and at six months, participants are asked to provide a stool (faeces) sample so that the level of inflammation in their intestines can be assessed, as well as undertaking a bone scan to assess changes in bone mineral density.
What are the possible benefits and risks of participating?
Potential benefits of participating include improvements in muscle function, bone strength, fatigue levels and quality of life. There are no direct risks of participating, as the exercise programmes have been found to be safe and participants’ progress will be closely overseen by a study investigator.
Where is the study run from?
1. Northumbria University (UK)
2. Freeman Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2016 to September 2019
Who is funding the study?
1. Northumbria University (UK)
2. PROCARE ApS (UK)
Who is the main contact?
Dr Garry Tew
Trial website
Contact information
Type
Scientific
Primary contact
Dr Garry Tew
ORCID ID
http://orcid.org/0000-0002-8610-0613
Contact details
Associate Professor of Exercise and Health Sciences
Department of Sport
Exercise and Rehabilitation
Northumbria University
Northumberland Building
Northumberland Road
Newcastle upon Tyne
NE1 8ST
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
35164
Study information
Scientific title
Effects of a 6-month practical resistance training programme on muscle function and bone mineral density in adults with inactive or mildly active Crohn’s disease: Study protocol for a randomised controlled trial
Acronym
Study hypothesis
The main aim of this study is to investigate the effects of a 6-month resistance training programme on muscle function and bone mineral density in adults with inactive or mildly-active Crohn’s disease.
Ethics approval
North East - Tyne & Wear South Research Ethics Committee,17/11/2017, ref: 17/NE/0308
Study design
Randomised; Interventional; Design type: Treatment, Physical, Rehabilitation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology; UKCRC code/ Disease: Oral and Gastrointestinal/ Other diseases of the digestive system
Intervention
Participants are randomly allocated to one of two groups. Those in the first group receive usual care only. Those in the second group receive usual care plus a six-month resistance training programme involving a combination of supervised and unsupervised exercise sessions. Each session will begin with a five-minute warm up, then approximately 45 minutes of whole-body resistance training (using body weight and elastic bands for resistance), and a three-minute cool down. At the start of the study, and then again at three and six months, participants complete a number of questionnaires and physical tests in order to find out if there has been any change to their muscle function, fatigue and quality of life. At the start of the study and at six months, participants are asked to provide a stool (faeces) sample so that the level of inflammation in their intestines can be assessed, as well as undertaking a bone scan to assess changes in bone mineral density.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Bone mineral density at the femoral neck, greater trochanter and lumbar spine (L2- L4) is measured using dual energy X-ray absorptiometry at baseline and 6 months
2. Maximum voluntary isometric and isokinetic strength of the elbow flexor and knee extensor muscles is measured using isokinetic dynamometry at baseline, 3 months and 6 months
3. Handgrip strength is measured using a handgrip dynamometer at baseline, 3 months and 6 months
4. Lower-limb muscle endurance is measured using the 30-second chair sit-to-stand test at baseline, 3 months and 6 months
5. Upper-limb muscle endurance is measured using the 30-s arm bicep curl test at baseline, 3 months and 6 months
Secondary outcome measures
1. Quality of life is measured using the Inflammatory Bowel Disease Quality of Life Questionnaire (IBDQ) at baseline, 3 months and 6 months
2. Health status is measured using the EuroQol 5-dimensions, 5-level questionnaire (EQ-5D-5L) at baseline, 3 months and 6 months
3. Fatigue is measured using the Inflammatory Bowel Disease Fatigue Scale (IBD-F) at baseline, 3 months and 6 months
4. Body mass is measured using balance beam scales at baseline and 6 months
5. Stature is measured using a stadiometer at baseline and 6 months
6. Disease activity is measured using the Crohn’s Disease Activity Index (CDAI) at baseline and 6 months
7. Bowel inflammation is determined by measuring faecal calprotectin at baseline and 6 months
8. Blood markers of inflammation (e.g. C-reactive protein) are measured at baseline and 6 months
9. Physical activity is measured using the Scottish Physical Activity Questionnaire (SPAQ) at baseline, 3 months and 6 months
10. Feasibility and acceptability outcomes will include rates of recruitment, retention, attrition, missing data, intervention adherence and adverse events, which will all be calculated once follow-up is complete
Overall trial start date
01/10/2016
Overall trial end date
31/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 16 years or older
2. Clinical diagnosis of Crohn’s disease for at least 4 weeks before screening visit
3. Inactive (<150 on Crohn’s Disease Activity Index [CDAI]) or mildly active (150-219 on CDAI) Crohn’s disease assessed no greater than 4 weeks before screening visit
4. Faecal calprotectin <250mcg/g recorded no greater than 4 weeks before screening visit
5. Stable medications for at least 4 weeks before screening visit
6. Able to provide written informed consent and complete the study questionnaires
7. Able to travel to the research centre for assessment visits and exercise sessions
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 50; UK Sample Size: 50
Total final enrolment
47
Participant exclusion criteria
1. Absolute contraindications or co-morbidities to exercise testing and training as defined by the American College of Sports Medicine
2. Deemed unsuitable to undertake resistance exercise (assessed by gastroenterologist/physician)
3. Planned major surgery within the first 6 months after randomisation
4. Female planning pregnancy within the first 6 months after randomisation
5. Pregnant
6. Current participation in > 2 sessions/week of resistance exercise (self-reported)
7. Participation in another clinical trial for with concurrent participation is deemed inappropriate
Recruitment start date
08/01/2018
Recruitment end date
28/02/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Northumbria University
Northumberland Road
Newcastle upon Tyne
NE1 8ST
United Kingdom
Trial participating centre
Freeman Hospital
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Funders
Funder type
Government
Funder name
Northumbria University
Alternative name(s)
Northumbria University, Newcastle
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Funder name
PROCARE ApS
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal within one year of the trial end date.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Garry Tew, Email: garry.tew@northumbria.ac.uk, anonymised participant level data.
Intention to publish date
27/09/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/33119156/ (added 30/10/2020)