Inflammatory Bowel DiseasesACHILLENCT04589338
Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease
A study testing Endurance training and Resistance training in people with Inflammatory Bowel Diseases and Exercise Therapy, run by University of Liege at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Exercise Therapy
- What is being tested?
- Endurance training and Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Jan 2021to 7 Feb 2023
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Inflammatory Bowel Diseases, Exercise Therapy
- Being tested
- Endurance training, Resistance training
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance trainingOther
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.
Resistance trainingOther
Patients in this group will perform lower limb strengthening exercises to improve the maximum strength of different muscle groups.
| Study group | Role | What they receive |
|---|---|---|
| Endurance training group | Experimental | Not described Receives: Other: Endurance training |
| Resistance training group | Experimental | Not described Receives: Other: Resistance training |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive effort test on bicycle ergometer (VO2 max)
This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)
Measured: day 1
Progressive effort test on bicycle ergometer (VO2 max)
This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)
Measured: through study completion, an average of 40 weeks
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.
Measured: day 1
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.
Measured: through study completion, an average of 40 weeks
Progressive effort test on bicycle ergometer (Power)
This test allows to measure maximum aerobic power in Watt.
Measured: day 1
Progressive effort test on bicycle ergometer (Power)
This test allows to measure maximum aerobic power in Watt.
Measured: through study completion, an average of 40 weeks
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.
Measured: Day 1
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.
Measured: through study completion, an average of 40 weeks
Blood sample
This type of tests includes biological monitoring to obtain information on biological parameters.
Measured: Day 1
Blood sample
This type of tests includes biological monitoring to obtain information on biological parameters.
Measured: through study completion, an average of 40 weeks
Saddle analysis
This type of tests includes biological monitoring to obtain information on biological parameters.
Measured: Day 1
Saddle analysis
This type of tests includes biological monitoring to obtain information on biological parameters.
Measured: through study completion, an average of 40 weeks
IBD-F
Participants will complete a questionnaire on fatigue perceived.
Measured: Week 1
IBD-F
Participants will complete a questionnaire on fatigue perceived.
Measured: Week 10
IBD-F
Participants will complete a questionnaire on fatigue perceived.
Measured: Week 20
Godin Leisure Time exercise questionnaire
Participants will complete a questionnaire on the level of physical activity
Measured: Week 1
Metabolic Equivalent Task questionnaire
Participants will complete a questionnaire on the level of inactivity
Measured: Week 1
Metabolic Equivalent Task questionnaire
Participants will complete a questionnaire on the level of inactivity
Measured: Week 10
Metabolic Equivalent Task questionnaire
Participants will complete a questionnaire on the level of inactivity
Measured: Week 20
Short Food Frequency Questionnaire
Participants will complete a questionnaire on their dietary habits
Measured: Week 1
Short Food Frequency Questionnaire
Participants will complete a questionnaire on their dietary habits
Measured: Week 10
Short Food Frequency Questionnaire
Participants will complete a questionnaire on their dietary habits
Measured: Week 20
EQ5D questionnaire
Participants will complete a questionnaire on their level of health
Measured: Week 1
EQ5D questionnaire
Participants will complete a questionnaire on their level of health
Measured: Week 10
EQ5D questionnaire
Participants will complete a questionnaire on their level of health
Measured: Week 20
Short health scale questionnaire
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Measured: Week 1
Short health scale questionnaire
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Measured: Week 10
Short health scale questionnaire
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start5 Jan 2021
- Primary completion15 Dec 2022
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gofflot Amandine, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589338
- Sponsor's protocol ID
- 20202021
- Acronym
- ACHILLE
- Status last verified
- May 2023
- First submitted
- 22 Sep 2020
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Types of Physical Activity in Patients With Chronic Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04589338
- Acronym / sponsor ID
- ACHILLE / 20202021
- Conditions
- Inflammatory Bowel Diseases, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 19 Oct 2020 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endurance training group | Experimental | Other: Endurance training |
| Resistance training group | Experimental | Other: Resistance training |
| Control group | No intervention | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Endurance trainingThis 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. | Other | Endurance training group |
| Resistance trainingPatients in this group will perform lower limb strengthening exercises to improve the maximum strength of different muscle groups. | Other | Resistance training group |
Primary outcome
Progressive effort test on bicycle ergometer (VO2 max)
Time frame: day 1
This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)
Progressive effort test on bicycle ergometer (VO2 max)
Time frame: through study completion, an average of 40 weeks
This test allows to measure VO2 in ml/min/kg (thanks to respiratory gases)
Progressive effort test on bicycle ergometer (Heart rate)
Time frame: day 1
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)
Time frame: through study completion, an average of 40 weeks
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)
Time frame: day 1
This test allows to measure maximum aerobic power in Watt.
Progressive effort test on bicycle ergometer (Power)
Time frame: through study completion, an average of 40 weeks
This test allows to measure maximum aerobic power in Watt.
Maximum force test (N/m)
Time frame: Day 1
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)
Time frame: through study completion, an average of 40 weeks
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
Time frame: Day 1
This type of tests includes biological monitoring to obtain information on biological parameters.
Blood sample
Time frame: through study completion, an average of 40 weeks
This type of tests includes biological monitoring to obtain information on biological parameters.
Saddle analysis
Time frame: Day 1
This type of tests includes biological monitoring to obtain information on biological parameters.
Saddle analysis
Time frame: through study completion, an average of 40 weeks
This type of tests includes biological monitoring to obtain information on biological parameters.
IBD-F
Time frame: Week 1
Participants will complete a questionnaire on fatigue perceived.
IBD-F
Time frame: Week 10
Participants will complete a questionnaire on fatigue perceived.
IBD-F
Time frame: Week 20
Participants will complete a questionnaire on fatigue perceived.
Godin Leisure Time exercise questionnaire
Time frame: Week 1
Participants will complete a questionnaire on the level of physical activity
Metabolic Equivalent Task questionnaire
Time frame: Week 1
Participants will complete a questionnaire on the level of inactivity
Metabolic Equivalent Task questionnaire
Time frame: Week 10
Participants will complete a questionnaire on the level of inactivity
Metabolic Equivalent Task questionnaire
Time frame: Week 20
Participants will complete a questionnaire on the level of inactivity
Short Food Frequency Questionnaire
Time frame: Week 1
Participants will complete a questionnaire on their dietary habits
Short Food Frequency Questionnaire
Time frame: Week 10
Participants will complete a questionnaire on their dietary habits
Short Food Frequency Questionnaire
Time frame: Week 20
Participants will complete a questionnaire on their dietary habits
EQ5D questionnaire
Time frame: Week 1
Participants will complete a questionnaire on their level of health
EQ5D questionnaire
Time frame: Week 10
Participants will complete a questionnaire on their level of health
EQ5D questionnaire
Time frame: Week 20
Participants will complete a questionnaire on their level of health
Short health scale questionnaire
Time frame: Week 1
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Short health scale questionnaire
Time frame: Week 10
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Short health scale questionnaire
Time frame: Week 20
Participants will complete a questionnaire to evaluate the level of the inflammatory bowel disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endurance training and Resistance training in people with Inflammatory Bowel Diseases and Exercise Therapy, run by University of Liege at 1 site in Belgium.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 9 May 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progressive effort test on bicycle ergometer (VO2 max) (time frame: day 1). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023.