Ulcerative ColitisNCT04143490

Effects of Exercise in Patients With Ulcerative Colitis

A study testing Exercise in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Manchester Metropolitan University at 1 site in United Kingdom.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Ulcerative Colitis, Inflammatory Bowel Diseases
What is being tested?: Exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited Kingdom
Study dates: 4 Nov 2019to Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

For ulcerative colitis patients;
Currently in remission of disease (asymptomatic at time of experiment)
Less than 3 periods of disease activity (periods of symptomatic activity) in the last 12 months
No history of surgery to alleviate condition severity
Taking regular standard medication for control of condition
Adult less than 50 years due to effects of exercise in older age

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Non-smokers
Regular exercisers (determined via verbal discussion)
For healthy controls;
No history of disease (as assessed by standard medical screening questionnaire)
Adult less than 50 years due to effects of exercise in older age
Non-smokers
Regular exercisers (determined via verbal discussion)

Who cannot join

For ulcerative colitis patients;
Currently in active period of disease (symptomatic at time of experiment)
More than 3 periods of disease activity (periods of symptomatic activity) in the last 12 months
History of surgery to alleviate condition severity
Taking non-standard medication for control of condition
Adult more than 50 years of age

Show all 15Show fewer

Under 18 years of age
Smokers
Sedentary or not regularly physically active (determined via verbal discussion)
For healthy controls;
History of disease (as assessed by standard medical screening questionnaire)
Adult more than 50 years of age
Under 18 years of age
Smokers
Sedentary or not regularly physically active (determined via verbal discussion)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Manchester Metropolitan University
Manchester, Greater Manchester, M1 5GD

Other trials in United Kingdom

About this study

Official title: The Effects of Exercise Intensity on Gastrointestinal Function and Inflammatory Markers in Patients With Ulcerative Colitis

The aim of this study is to investigate the effects of moderate to high intensity exercise on gut function and inflammatory markers in patients with Ulcerative Colitis (UC), and to compare them with individuals of matched age who do not suffer from Inflammatory Bowel Disease. Participants will be asked to complete 60 minutes of continuous cycling at a moderate to high intensity followed by a three hour recovery period. Gastrointestinal function will be measured using a non-invasive breath test. Blood samples will be collected at multiple time-points during the visit and these samples will be measured for markers of immune function and intestinal integrity.

Read the detailed description

There is limited research on the effect of exercise on patients with Ulcerative Colitis. The aim of this investigation is to study the acute effects of moderate to high intensity exercise on gut function in patients with Ulcerative Colitis and to compare them with individuals of matched age who do not suffer from Inflammatory Bowel Disease.

Patients in remission from disease activity and age and gender matched healthy control participants will be recruited from the general population. Participants will attend the laboratory on two occasions. The first visit will last approximately one hour and will include an exercise test to determine peak oxygen uptake capacity (VO2peak) which is an indicator of cardiorespiratory fitness. The second visit will last for approximately four and a half hours and will consist of a 60 minute continuous cycle on a stationary cycle ergometer at an intensity of 65% VO2peak followed by a recovery period. Gastric emptying rate of a commercially available sports drink will be measured and blood samples will be collected at regular time-points throughout the visit and analysed for concentrations of inflammatory markers and intestinal integrity/function.

Conditions: Ulcerative Colitis, Inflammatory Bowel Diseases
Being tested: Exercise
Keywords: Ulcerative Colitis, Inflammatory Bowel Disease, Exercise, Gastric emptying rate, Inflammatory markers, Gastrointestinal integrity
Medical subject headings: Colitis, Ulcerative, Inflammatory Bowel Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExerciseOther
60 minutes of continuous exercise at 65% VO2peak and drink ingestion

Study groups in NCT04143490
Study group	Role	What they receive
UC Patients	Experimental	Patient group Receives: Other: Exercise
Healthy controls	Active comparator	Control group Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in inflammatory markers or hormones
Circulating concentrations of Interleukin-6, Tumor Necrosis Factor-alpha, C-reactive protein, glucagon like peptide 2
Measured: 6 blood samples collected at baseline, 30 minutes of exercise (mid exercise), immediately post exercise bout, then every 60 minutes post exercise for 3 hours
Area under the circulating concentration versus time curve (AUC) of inflammatory markers or hormones
Responses of Interleukin-6, Tumor Necrosis Factor-alpha, C-reactive protein, glucagon like peptide 2
Measured: 4.5 hours
Change in intestinal epithelial damage and permeability markers
Circulating concentrations of intestinal fatty acid binding protein and claudin-3
Measured: 6 blood samples collected at baseline, 30 minutes of exercise (mid exercise), immediately post exercise bout, then every 60 minutes post exercise for 3 hours
Area under the circulating concentration versus time curve (AUC) of intestinal epithelial damage and permeability markers
Responses of intestinal fatty acid binding protein and claudin-3
Measured: 4.5 hours
Change in exercise induced endotoxaemia markers
Circulating concentrations of plasma lipopolysaccharide
Measured: 6 blood samples collected at baseline, 30 minutes of exercise (mid exercise), immediately post exercise bout, then every 60 minutes post exercise for 3 hours
Area under the circulating concentration versus time curve (AUC) of exercise induced endotoxaemia markers
Response of plasma lipopolysaccharide
Measured: 4.5 hours
Gastric emptying rate half time and time of maximal emptying rate
Emptying rate of a commercially available sports drink from the stomach using the 13C breath test method
Measured: 2 hours after ingestion of drink
Change in ratio of 13C/12C in breath samples
Gastric emptying profile of a commercially available sports drink from the stomach using the 13C breath test method
Measured: 9 breath samples collected at baseline, then every 15 minutes after ingestion for 2 hours

Secondary outcomes (11)

Incidence and severity of gastrointestinal symptoms
10-point rating scale for gastrointestinal symptoms (Visual Analogue Scale modified). 19 item questionnaire with 5 subcategories (Overall gut discomfort, total gastrointestinal symptoms, upper gastrointestinal symptoms, lower gastrointestinal symptoms and other gastrointestinal symptoms). Scores for each item ranging from 0 (no symptom) to 10 (extremely severe symptoms causing exercise reduction, stopping, or complete withdrawal). Higher scores represent higher severity of symptoms.
Measured: Immediately post-exercise bout and 3 hours post exercise.
Heart rate response
Heart rate telemetry
Measured: Every 5 minutes during 60 minute cycle
Disparity of subjective exertion and objective cardiorespiratory parameters
Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and cardiopulmonary exercise testing variables of oxygen uptake, carbon dioxide expiration, ventilatory threshold, volume of air expired, and tidal volume (all parameters measured in L/min).
Measured: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Disparity of subjective exertion and objective heart rate
Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and heart rate measured by telemetry
Measured: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Disparity of subjective exertion and breathing frequency
Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and number of breaths per minute
Measured: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Disparity of subjective exertion and oxygen pulse
Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and oxygen pulse calculated by dividing oxygen uptake by heart rate.
Measured: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Disparity of subjective exertion and respiratory exchange ratio
Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and respiratory exchange ratio calculated by dividing carbon dioxide production by oxygen uptake.
Measured: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Disparity of subjective exertion and ventilatory efficiency
Regression of ratings of perceived exertion (RPE; Borg scale, minimum value 6 representing no exertion, maximum value 20 representing maximal exertion. Higher scores represent higher perceived exertion) and minute ventilation/carbon dioxide slope (VE/VCO2 slope).
Measured: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Subjective physical activity levels
International Physical Activity Questionnaire (IPAQ). Answers to questions (time spent completing different physical activities) converted to Metabolic Equivalent (METs) hours per week. Minimum value of zero, no limit to maximum. Higher MET values indicate higher physical activity levels.
Measured: Prior to experimental trial
Attitudes and beliefs towards physical activity
Barriers to Physical Activity Questionnaire. 21 item questionnaire, each question rated from 0 (very unlikely) to 3 (very likely). Each item belongs to one of 7 categories relating to barriers to physical activity. Score totals greater than 5 indicate the category as being a significant barrier.
Measured: Prior to experimental trial
Subjective health related quality of life: RAND 36-Item Short Form Health Survey (SF-36)
RAND 36-Item Short Form Health Survey (SF-36). 36-item questionnaire covering 8 concepts; physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions, plus single item providing an indication of perceived change in health. Scores ranging from 0 to 100 for each concept with 100 indicating good health and 0 being poor health.
Measured: Prior to experimental trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 2019Dec 2025

First posted29 Oct 2019
Study start4 Nov 2019
Primary completionSep 2024 (estimated)
Study completionDec 2025 (estimated)

Why it stopped: Due to Covid-19

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Single experimental trial with a UC patient group and an age and gender matched healthy control group
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04143490
Sponsor's protocol ID: ExerciseUC-2019
Status last verified: Jan 2023
First submitted: 15 Oct 2019
Last updated: 5 Jan 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Planned communication of group results at a scientific conference. Planned publication in a scientific peer reviewed journal. Participant level data is not expected to be available as this complies with the conditions of the ethical approval granted for this study.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Exercise Intensity on Gastrointestinal Function and Inflammatory Markers in Patients With Ulcerative Colitis
ClinicalTrials.gov ID: NCT04143490
Acronym / sponsor ID: ExerciseUC-2019
Conditions: Ulcerative Colitis, Inflammatory Bowel Diseases
Keywords: Ulcerative Colitis, Inflammatory Bowel Disease, Exercise, Gastric emptying rate, Inflammatory markers, Gastrointestinal integrity
Study type: Interventional
Recruitment status: SuspendedReason stopped: Due to Covid-19
Enrolment: 24 participants (estimated)
Lead sponsor: Manchester Metropolitan UniversityUniversity, hospital or other
Collaborators: University of Manchester
Study start: 4 Nov 2019 (actual)
Primary completion: Sep 2024 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 29 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Single experimental trial with a UC patient group and an age and gender matched healthy control group

Arm	Type	Receives
UC Patients	Experimental	Other: ExercisePatient group
Healthy controls	Active comparator	Other: ExerciseControl group

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

For ulcerative colitis patients;
Currently in remission of disease (asymptomatic at time of experiment)
Less than 3 periods of disease activity (periods of symptomatic activity) in the last 12 months
No history of surgery to alleviate condition severity
Taking regular standard medication for control of condition

Key exclusion criteria (15 listed)

For ulcerative colitis patients;
Currently in active period of disease (symptomatic at time of experiment)
More than 3 periods of disease activity (periods of symptomatic activity) in the last 12 months
History of surgery to alleviate condition severity
Taking non-standard medication for control of condition

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exercise60 minutes of continuous exercise at 65% VO2peak and drink ingestion	Other	Healthy controls, UC Patients

Primary outcome

Change in inflammatory markers or hormones
Time frame: 6 blood samples collected at baseline, 30 minutes of exercise (mid exercise), immediately post exercise bout, then every 60 minutes post exercise for 3 hours
Circulating concentrations of Interleukin-6, Tumor Necrosis Factor-alpha, C-reactive protein, glucagon like peptide 2
Area under the circulating concentration versus time curve (AUC) of inflammatory markers or hormones
Time frame: 4.5 hours
Responses of Interleukin-6, Tumor Necrosis Factor-alpha, C-reactive protein, glucagon like peptide 2
Change in intestinal epithelial damage and permeability markers
Time frame: 6 blood samples collected at baseline, 30 minutes of exercise (mid exercise), immediately post exercise bout, then every 60 minutes post exercise for 3 hours
Circulating concentrations of intestinal fatty acid binding protein and claudin-3
Area under the circulating concentration versus time curve (AUC) of intestinal epithelial damage and permeability markers
Time frame: 4.5 hours
Responses of intestinal fatty acid binding protein and claudin-3
Change in exercise induced endotoxaemia markers
Time frame: 6 blood samples collected at baseline, 30 minutes of exercise (mid exercise), immediately post exercise bout, then every 60 minutes post exercise for 3 hours
Circulating concentrations of plasma lipopolysaccharide
Area under the circulating concentration versus time curve (AUC) of exercise induced endotoxaemia markers
Time frame: 4.5 hours
Response of plasma lipopolysaccharide
Gastric emptying rate half time and time of maximal emptying rate
Time frame: 2 hours after ingestion of drink
Emptying rate of a commercially available sports drink from the stomach using the 13C breath test method
Change in ratio of 13C/12C in breath samples
Time frame: 9 breath samples collected at baseline, then every 15 minutes after ingestion for 2 hours
Gastric emptying profile of a commercially available sports drink from the stomach using the 13C breath test method

11 secondary outcomes

Incidence and severity of gastrointestinal symptoms
Time frame: Immediately post-exercise bout and 3 hours post exercise.
Heart rate response
Time frame: Every 5 minutes during 60 minute cycle
Disparity of subjective exertion and objective cardiorespiratory parameters
Time frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Disparity of subjective exertion and objective heart rate
Time frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Disparity of subjective exertion and breathing frequency
Time frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Disparity of subjective exertion and oxygen pulse
Time frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Disparity of subjective exertion and respiratory exchange ratio
Time frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Disparity of subjective exertion and ventilatory efficiency
Time frame: Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes
Subjective physical activity levels
Time frame: Prior to experimental trial
Attitudes and beliefs towards physical activity
Time frame: Prior to experimental trial
Subjective health related quality of life: RAND 36-Item Short Form Health Survey (SF-36)
Time frame: Prior to experimental trial

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
Individual participant dataSharing planned: No. Planned communication of group results at a scientific conference. Planned publication in a scientific peer reviewed journal. Participant level data is not expected to be available as this complies with the conditions of the ethical approval granted for this study.

Related trials for Ulcerative Colitis

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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gethin H Evans, PhD principal investigator

Manchester Metropolitan University

Adora MW Yau, PhD principal investigator

Manchester Metropolitan University

John McLaughlin, Prof. principal investigator

University of Manchester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Manchester Metropolitan University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in inflammatory markers or hormones (time frame: 6 blood samples collected at baseline, 30 minutes of exercise (mid exercise), immediately post exercise bout, then every 60 minutes post exercise for 3 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04143490.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.