Effects of Exercise in Patients With Ulcerative Colitis

NCT04143490 | Suspended

• 1 other identifier: ExerciseUC-2019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases

Keywords

Ulcerative Colitis; Inflammatory Bowel Disease; Exercise; Gastric emptying rate; Inflammatory markers; Gastrointestinal integrity

Outcome Measures

Primary Outcomes (8)

• Change in inflammatory markers or hormones

  Circulating concentrations of Interleukin-6, Tumor Necrosis Factor-alpha, C-reactive protein, glucagon like peptide 2

  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

  4.5 hours

• Change in intestinal epithelial damage and permeability markers

  Circulating concentrations of intestinal fatty acid binding protein and claudin-3

  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

  4.5 hours

• Change in exercise induced endotoxaemia markers

  Circulating concentrations of plasma lipopolysaccharide

  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

  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

  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

  9 breath samples collected at baseline, then every 15 minutes after ingestion for 2 hours

Secondary Outcomes (11)

• Incidence and severity of gastrointestinal symptoms

  Immediately post-exercise bout and 3 hours post exercise.

• Heart rate response

  Every 5 minutes during 60 minute cycle

• Disparity of subjective exertion and objective cardiorespiratory parameters

  Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes

• Disparity of subjective exertion and objective heart rate

  Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes

• Disparity of subjective exertion and breathing frequency

  Every minute during the peak oxygen uptake test that typically lasts between 8-12 minutes

Study Arms (2)

UC Patients

EXPERIMENTAL

Patient group

Other: Exercise

Healthy controls

ACTIVE COMPARATOR

Control group

Other: Exercise

Interventions

Exercise OTHER

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

Healthy controls; UC Patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Manchester Metropolitan University: lead
• University of Manchester: collaborator

Study Sites (1)

Manchester Metropolitan University

Manchester, Greater Manchester, M1 5GD, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gethin H Evans, PhD

  Manchester Metropolitan University

  PRINCIPAL INVESTIGATOR

• Adora MW Yau, PhD

  Manchester Metropolitan University

  PRINCIPAL INVESTIGATOR

• John McLaughlin, Prof.

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Single experimental trial with a UC patient group and an age and gender matched healthy control group

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 29, 2019
• Study Start: November 4, 2019
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)