Effects of Exercise in Patients With Ulcerative Colitis

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Primary Purpose

Status

Suspended

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional basic science trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Inflammatory Bowel Disease, Exercise, Gastric emptying rate, Inflammatory markers, Gastrointestinal integrity

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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)

Sites / Locations

Manchester Metropolitan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

UC Patients

Healthy controls

Arm Description

Patient group

Control group

Outcomes

Primary Outcome Measures

Change in inflammatory markers or hormones

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

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

Change in intestinal epithelial damage and permeability markers

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

Responses of intestinal fatty acid binding protein and claudin-3

Change in exercise induced endotoxaemia markers

Circulating concentrations of plasma lipopolysaccharide

Area under the circulating concentration versus time curve (AUC) of exercise induced endotoxaemia markers

Response of plasma lipopolysaccharide

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

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

Secondary Outcome Measures

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.

Heart rate response

Heart rate telemetry

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).

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

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

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.

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.

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).

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.

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.

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.

Full Information

NCT ID

NCT04143490

First Posted

October 15, 2019

Last Updated

January 4, 2023

Sponsor

Manchester Metropolitan University

Collaborators

University of Manchester

1. Study Identification

Unique Protocol Identification Number

NCT04143490

Brief Title

Effects of Exercise in Patients With Ulcerative Colitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Suspended

Why Stopped

Due to Covid-19

Study Start Date

November 4, 2019 (Actual)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Manchester Metropolitan University

Collaborators

University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis, Inflammatory Bowel Diseases

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

UC Patients

Arm Type

Experimental

Arm Description

Patient group

Arm Title

Healthy controls

Arm Type

Active Comparator

Arm Description

Control group

Intervention Type

Other

Intervention Name(s)

Exercise

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in inflammatory markers or hormones

Description

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

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

Title

Area under the circulating concentration versus time curve (AUC) of inflammatory markers or hormones

Description

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

Time Frame

4.5 hours

Title

Change in intestinal epithelial damage and permeability markers

Description

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

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

Title

Area under the circulating concentration versus time curve (AUC) of intestinal epithelial damage and permeability markers

Description

Responses of intestinal fatty acid binding protein and claudin-3

Time Frame

4.5 hours

Title

Change in exercise induced endotoxaemia markers

Description

Circulating concentrations of plasma lipopolysaccharide

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

Title

Area under the circulating concentration versus time curve (AUC) of exercise induced endotoxaemia markers

Description

Response of plasma lipopolysaccharide

Time Frame

4.5 hours

Title

Gastric emptying rate half time and time of maximal emptying rate

Description

Emptying rate of a commercially available sports drink from the stomach using the 13C breath test method

Time Frame

2 hours after ingestion of drink

Title

Change in ratio of 13C/12C in breath samples

Description

Gastric emptying profile of a commercially available sports drink from the stomach using the 13C breath test method

Time Frame

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

Secondary Outcome Measure Information:

Title

Incidence and severity of gastrointestinal symptoms

Description

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.

Time Frame

Immediately post-exercise bout and 3 hours post exercise.

Title

Heart rate response

Description

Heart rate telemetry

Time Frame

Every 5 minutes during 60 minute cycle

Title

Disparity of subjective exertion and objective cardiorespiratory parameters

Description

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).

Time Frame