Condition category
Digestive System
Date applied
11/12/2017
Date assigned
12/12/2017
Last edited
12/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

N/A

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

27/09/2019

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

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

07/01/2019

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

Sponsor information

Organisation

Northumbria University Newcastle

Sponsor details

Research and Innovation Services
Northumberland Building
056
Newcastle
NE1 8ST
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Northumbria University

Alternative name(s)

Northumbria University, Newcastle

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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

Publication citations

Additional files

Editorial Notes