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Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease (ACHILLE)

Primary Purpose

Inflammatory Bowel Diseases, Exercise Therapy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Endurance training
Resistance training
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Diseases

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients in remission defined by a Harvey Bradshaw Index 5 in Crohn's disease (CD) and a clinical Mayo 3 with no sub-score >1 in ulcerative colitis (RCUH) with stable treatment, without corticosteroid for 4 months.
  • Patients accepting the study protocol

Exclusion Criteria:

  • Patients suffering from other pathologies (at the level of the digestive system, the cardiovascular system, as well as the musculoskeletal system: recent knee plasty, recent knee fractures, etc.), which can interfere with planned tests and activity programs.
  • Patients with more than 3 hours of sports activity per week
  • Pregnant, pregnant or nursing patients

Sites / Locations

  • Université de Liège

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Endurance training group

Resistance training group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Progressive effort test on bicycle ergometer (VO2 max)
This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)
Progressive effort test on bicycle ergometer (VO2 max)
This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)
Progressive effort test on bicycle ergometer (Heart rate)
This test allows to measure resting and maximum heart rate (thanks to an ECG) and maximum aerobic power in Watt.
Progressive effort test on bicycle ergometer (Heart rate)
This test allows to measure resting and maximum heart rate (thanks to an ECG) and maximum aerobic power in Watt.
Progressive effort test on bicycle ergometer (Power)
This test allows to measure maximum aerobic power in Watt.
Progressive effort test on bicycle ergometer (Power)
This test allows to measure maximum aerobic power in Watt.
Maximum force test (N/m)
This test will be performed using an isokinetic dynamometer. This evaluation will allow us to determine the maximum force of the quadriceps and hamstrings of each participant in N/m.
Maximum force test (N/m)
This test will be performed using an isokinetic dynamometer. This evaluation will allow us to determine the maximum force of the quadriceps and hamstrings of each participant in N/m.
Blood sample
This type of tests includes biological monitoring to obtain information on biological parameters.
Blood sample
This type of tests includes biological monitoring to obtain information on biological parameters.
Saddle analysis
This type of tests includes biological monitoring to obtain information on biological parameters.
Saddle analysis
This type of tests includes biological monitoring to obtain information on biological parameters.
IBD-F
Participants will complete a questionnaire on fatigue perceived.
IBD-F
Participants will complete a questionnaire on fatigue perceived.
IBD-F
Participants will complete a questionnaire on fatigue perceived.
Godin Leisure Time exercise questionnaire
Participants will complete a questionnaire on the level of physical activity
Metabolic Equivalent Task questionnaire
Participants will complete a questionnaire on the level of inactivity
Metabolic Equivalent Task questionnaire
Participants will complete a questionnaire on the level of inactivity
Metabolic Equivalent Task questionnaire
Participants will complete a questionnaire on the level of inactivity
Short Food Frequency Questionnaire
Participants will complete a questionnaire on their dietary habits
Short Food Frequency Questionnaire
Participants will complete a questionnaire on their dietary habits
Short Food Frequency Questionnaire
Participants will complete a questionnaire on their dietary habits
EQ5D questionnaire
Participants will complete a questionnaire on their level of health
EQ5D questionnaire
Participants will complete a questionnaire on their level of health
EQ5D questionnaire
Participants will complete a questionnaire on their level of health
Short health scale questionnaire
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Short health scale questionnaire
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Short health scale questionnaire
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease

Secondary Outcome Measures

Full Information

First Posted
September 22, 2020
Last Updated
May 8, 2023
Sponsor
University of Liege
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1. Study Identification

Unique Protocol Identification Number
NCT04589338
Brief Title
Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease
Acronym
ACHILLE
Official Title
Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
February 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege

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
This is a prospective interventional study. The investigators will include patients in clinical remission who are on stable treatment. These IBD patients will be followed to analyze the effects of physical activity on their inflammatory disease. Different exercises will be offered to two separate groups of randomly distributed patients: the first group will perform muscle building exercises while the other group will be offered aerobic exercises.There will also be a control group that does not initially benefit from a specific physical activity program. However, this group will be integrated into one of the other two groups after the 10-week follow-up. All three groups will perform the same baseline tests. These will be of different types: physical tests, biological tests and quality of life questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Exercise Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endurance training group
Arm Type
Experimental
Arm Title
Resistance training group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Endurance training
Intervention Description
This group will perform aerobic type exercises. Initially, patients will perform continuous exercises of progressive intensity in order to adapt to this kind of effort. Next, we will introduce interval exercises.
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
Patients in this group will perform lower limb strengthening exercises to improve the maximum strength of different muscle groups.
Primary Outcome Measure Information:
Title
Progressive effort test on bicycle ergometer (VO2 max)
Description
This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)
Time Frame
day 1
Title
Progressive effort test on bicycle ergometer (VO2 max)
Description
This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)
Time Frame
through study completion, an average of 40 weeks
Title
Progressive effort test on bicycle ergometer (Heart rate)
Description
This test allows to measure resting and maximum heart rate (thanks to an ECG) and maximum aerobic power in Watt.
Time Frame
day 1
Title
Progressive effort test on bicycle ergometer (Heart rate)
Description
This test allows to measure resting and maximum heart rate (thanks to an ECG) and maximum aerobic power in Watt.
Time Frame
through study completion, an average of 40 weeks
Title
Progressive effort test on bicycle ergometer (Power)
Description
This test allows to measure maximum aerobic power in Watt.
Time Frame
day 1
Title
Progressive effort test on bicycle ergometer (Power)
Description
This test allows to measure maximum aerobic power in Watt.
Time Frame
through study completion, an average of 40 weeks
Title
Maximum force test (N/m)
Description
This test will be performed using an isokinetic dynamometer. This evaluation will allow us to determine the maximum force of the quadriceps and hamstrings of each participant in N/m.
Time Frame
Day 1
Title
Maximum force test (N/m)
Description
This test will be performed using an isokinetic dynamometer. This evaluation will allow us to determine the maximum force of the quadriceps and hamstrings of each participant in N/m.
Time Frame
through study completion, an average of 40 weeks
Title
Blood sample
Description
This type of tests includes biological monitoring to obtain information on biological parameters.
Time Frame
Day 1
Title
Blood sample
Description
This type of tests includes biological monitoring to obtain information on biological parameters.
Time Frame
through study completion, an average of 40 weeks
Title
Saddle analysis
Description
This type of tests includes biological monitoring to obtain information on biological parameters.
Time Frame
Day 1
Title
Saddle analysis
Description
This type of tests includes biological monitoring to obtain information on biological parameters.
Time Frame
through study completion, an average of 40 weeks
Title
IBD-F
Description
Participants will complete a questionnaire on fatigue perceived.
Time Frame
Week 1
Title
IBD-F
Description
Participants will complete a questionnaire on fatigue perceived.
Time Frame
Week 10
Title
IBD-F
Description
Participants will complete a questionnaire on fatigue perceived.
Time Frame
Week 20
Title
Godin Leisure Time exercise questionnaire
Description
Participants will complete a questionnaire on the level of physical activity
Time Frame
Week 1
Title
Metabolic Equivalent Task questionnaire
Description
Participants will complete a questionnaire on the level of inactivity
Time Frame
Week 1
Title
Metabolic Equivalent Task questionnaire
Description
Participants will complete a questionnaire on the level of inactivity
Time Frame
Week 10
Title
Metabolic Equivalent Task questionnaire
Description
Participants will complete a questionnaire on the level of inactivity
Time Frame
Week 20
Title
Short Food Frequency Questionnaire
Description
Participants will complete a questionnaire on their dietary habits
Time Frame
Week 1
Title
Short Food Frequency Questionnaire
Description
Participants will complete a questionnaire on their dietary habits
Time Frame
Week 10
Title
Short Food Frequency Questionnaire
Description
Participants will complete a questionnaire on their dietary habits
Time Frame
Week 20
Title
EQ5D questionnaire
Description
Participants will complete a questionnaire on their level of health
Time Frame
Week 1
Title
EQ5D questionnaire
Description
Participants will complete a questionnaire on their level of health
Time Frame
Week 10
Title
EQ5D questionnaire
Description
Participants will complete a questionnaire on their level of health
Time Frame
Week 20
Title
Short health scale questionnaire
Description
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Time Frame
Week 1
Title
Short health scale questionnaire
Description
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Time Frame
Week 10
Title
Short health scale questionnaire
Description
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Time Frame
Week 20

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients in remission defined by a Harvey Bradshaw Index 5 in Crohn's disease (CD) and a clinical Mayo 3 with no sub-score >1 in ulcerative colitis (RCUH) with stable treatment, without corticosteroid for 4 months. Patients accepting the study protocol Exclusion Criteria: Patients suffering from other pathologies (at the level of the digestive system, the cardiovascular system, as well as the musculoskeletal system: recent knee plasty, recent knee fractures, etc.), which can interfere with planned tests and activity programs. Patients with more than 3 hours of sports activity per week Pregnant, pregnant or nursing patients
Facility Information:
Facility Name
Université de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

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Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease

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