Inflammatory Bowel DiseasesENERGIZE-IBDNCT05657197
The Effect of Intensive Physical Exercise on Fatigue and Quality of Life in Patients With Quiescent Inflammatory Bowel Disease
A study testing Exercise intervention in people with Inflammatory Bowel Diseases, run by Rijnstate Hospital at 3 sites in Netherlands.
Trial summary
In patients with inflammatory bowel diseases (IBD), characterized by relapsing intestinal inflammation, chronic fatigue is a burdensome and highly prevalent symptom. The aetiology is thought to be multifactorial, including complex interactions of psychological and physical factors such as immunological profiles and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesNetherlands
- Study dates
- 10 Jan 2023to 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥1 year diagnosis of IBD, including Crohn's disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U), based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria;
- Chronic fatigue complaints for at least 3 months;
- Severe fatigue complaints as confirmed with a score of ≥11 on section I of the inflammatory bowel disease fatigue self-assessment scale (IBD-F);
- Clinically quiescent IBD with a Harvey Bradshaw Index (HBI) <5 for Crohn's disease patients or a Simple Colitis Clinical Activity Index (SCCAI) ≤2 for patients with ulcerative colitis or IBD-unclassified;
- Faecal calprotectin <100 μg/g;
- Stable medication for at least 3 months before screening visit;
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- Patient is able and willing to provide written informed consent;
- Patient is able/commitment to make a time investment to complete the intervention program (one hour training 3x/week during 12 weeks) or, after randomisation, willing to participate in the control group;
- Patient is aged between 18 and 60 years.
Who cannot join
- Performing moderate-vigorous intensity exercise (i.e. swimming, running, cycling) more than once and/or >90 minutes per week in the past 3 months;
- Surgery within the past 6 months or planned surgery within 12 months after the screening visit;
- Participation in another intervention study;
- Pregnant at the moment of the screening visit or planning pregnancy within 12 months after the screening;
- Confirmed diagnosis of other causes of fatigue complaints, such as thyroid dysfunction, liver or renal failure, anaemia, folate-, iron-, vitamin B12- or D deficiency.
- Comorbidities that could be confounders for fatigue, such as Chronic obstructive pulmonary disease (COPD), heart failure, active malignancy, long/Post-COVID and patients under treatment for a psychiatric disorder (i.e. depression/anxiety)
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- Comorbidities that prevent safe participation in the exercise program/cardiorespiratory fitness test including;
- Very high risk of cardiovascular disease
- Uncontrolled diabetes mellitus with HbA1c > 65 mmol/l.
- Cardiovascular disease (i.e. acute myocardial infarct, unstable angina, uncontrolled arrhythmias, aortic stenosis, stenotic valvular heart disease, untreated arterial hypertension (>200 mmHg systolic, >120 mmHg diastolic))
- Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, thyrotoxicosis)
- Uncontrolled asthma
- Pulmonary oedema
- Significant pulmonary hypertension
- Acute pulmonary embolus or pulmonary infarction
- Room air desaturation at rest <85% (exercise with supplemental O2)
- Respiratory failure
- Electrolyte abnormalities (sodium, potassium, calcium, magnesium)
- Mental impairment leading to inability to cooperate
- Orthopaedic impairment that compromise exercise performance
- BMI ≥35
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites, 3 recruiting
- Recruiting
Jeroen Bosch Hospital
's-Hertogenbosch, S' Hertogenbosch, 5223 GZ
D Oomkens, MD MSc, 06 - 50 08 45 90, Energize_IBD@rijnstate.nl
Dr. T.E.H. Römkens, MD, PhD
- Recruiting
Rijnstate Hospital
Arnhem, Gelderland, 6815 AD
D Oomkens, MD MSc, 088 - 005 6800, Energize_IBD@rijnstate.nl
Dr. M.J.M. Groenen, MD, PhD
- Recruiting
Radboud Univeristy Medical Center
Nijmegen, Gelderland, 6525 GA
D Oomkens, MD MSc, 06 - 50 08 45 90, Energize_IBD@rijnstate.nl
Dr. M. Duijvesteijn, MD, PhD
About this study
Official title: ENERGIZE IBD - The Effect of Intensive Physical Exercise on Fatigue and Quality of Life in Patients With Quiescent Inflammatory Bowel Disease: A Randomized Controlled Trial
In patients with inflammatory bowel diseases (IBD), characterized by relapsing intestinal inflammation, chronic fatigue is a burdensome and highly prevalent symptom. The aetiology is thought to be multifactorial, including complex interactions of psychological and physical factors such as immunological profiles and gut microbiota. Unfortunately, specific treatment strategies are currently lacking. Since fatigued patients have an impaired physical fitness and are less physically active than patients without fatigue, it is hypothesised that physical exercise might be an effective complementary treatment for patients with IBD suffering from fatigue. During a previous pilot cohort study, significant improvements in fatigue complaints and quality of life were observed following a personalised and intensive exercise program. In this study, a multicenter randomized controlled trial will be performed to further investigate this assumed beneficial effect of intensive physical exercise.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Exercise intervention, Usual care
- Keywords
- Fatigue, Exercise, Quality of life, IBD
- Medical subject headings
- Inflammatory Bowel Diseases, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise interventionBehavioural
A 12-week exercise program consisting of three times per week 1-hour sessions, including 30-minutes aerobic- and 30-minutes progressive resistance training. The intensity of training will be adjusted to each individual, based on a cardiopulmonary exercise test. Training sessions will be performed in groups of 10 participants under supervision of a sports physical therapist.
Usual careOther
Usual care, including general advice concerning chronic fatigue.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (exercise) group | Experimental | The patients in the intervention group will follow a personalised and intensive exercise program. Receives: Behavioral: Exercise intervention |
| Control group | Other | The patients in the control group will receive usual care. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue (IBD-F), post-intervention
Mean change in fatigue, measured with the inflammatory bowel disease fatigue self-assessment scale (IBD-F) 0-140 with higher scores indicating worse fatigue, in the intervention group compared to the control group.
Measured: 3 months (post-intervention)
Change in quality of life (IBDQ), post-intervention
Mean change in quality of life, measured with the inflammatory bowel disease questionnaire (IBDQ) 32-224 with higher scores representing better quality of life, in the intervention group compared to the control group.
Measured: 3 months (post-intervention)
Secondary outcomes (17)
Long-term change in fatigue (IBD-F)
Mean change in fatigue, as measured after 6- and 12-months using the IBD-F, in the intervention group compared to the control group
Measured: 6- and 12-months
Long-term change in quality of life (IBDQ)
Mean change in quality of life, as measured after 6- and 12-months using the IBDQ, in the intervention group compared to the control group
Measured: 6- and 12-months
Change in cardiorespiratory fitness (maximum oxygen uptake)
Change in cardiorespiratory fitness (maximum oxygen uptake) of patients in the intervention group, assessed using Cardiopulmonary Exercise Testing (CPET).
Measured: 3 months (post-intervention)
Change in cardiorespiratory fitness (maximum power)
Change in cardiorespiratory fitness (maximum power) of patients in the intervention group, assessed using Cardiopulmonary Exercise Testing (CPET).
Measured: 3 months (post-intervention)
Change in muscular strength
Change in muscular strength of patients in the intervention group, assessed using one-repetition maximum (1-RM)
Measured: 3 months (post-intervention)
Change in body composition (BMI)
Change in body composition in the intervention group, as determined by body mass index (BMI).
Measured: 3 months (post-intervention)
Change in body composition (body fat percentage)
Change in body composition in the intervention group, as determined by body fat percentage measured using skinfold techniques
Measured: 3 months (post-intervention)
Change in work absenteeism and presenteeism
Change in work absenteeism and presenteeism in the intervention group compared to the control group, as measured by the Productivity Cost Questionnaire (iPCQ)
Measured: T= 3-, 6-, 9-, and 12-months
Disease activity (FCP)
Disease activity measured by change in faecal calprotectin (FCP), in both the intervention- and control group
Measured: T= 3-, 6-, 9-, and 12-months
Disease activity (step-up therapy)
Disease activity measured by step-up therapy rate in both the intervention- and control group
Measured: T= 3-, 6-, 9-, and 12-months
Disease activity (exacerbation rate)
Disease activity measured by exacerbation rate in both the intervention- and control group
Measured: T= 3-, 6-, 9-, and 12-months
Change in sleep quality
Self-reported differences in sleep quality in the intervention group compared to the control group, using the Pittsburgh Sleep Quality Index (PSQI), 0-21 with higher scores indicating worse sleep quality.
Measured: T= 3-, 6-, 9-, and 12-months
Change in anxiety and depression symptoms
Mean change in anxiety and depression symptoms in the intervention group compared to the control group, measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire, each subscale 0-21 higher scores indicating worse symptoms
Measured: T= 3-, 6-, 9-, and 12-months
Targeted cost-utility analysis
Targeted economic evaluation of the intervention using a targeted cost-utility analysis from a societal perspective including intervention costs, medical consumption costs and productivity loss. Effectiveness of the intervention will be determined using the mean Difference of quality adjusted life years (QALYs) between de intervention and control group, based on the designated EQ-5D-5L questionnaire.
Measured: 12 months
Exploratory outcome measurements (immunological profiles)
Differences in the immunological profiles (i.e. pro- and anti-inflammatory cytokines and soluble receptors, such as IL-10, IL-6, IFN-ɣ) in the intervention group compared to the control group
Measured: 3 months (post-intervention)
Exploratory outcome measurements (gut microbiota)
Differences in the gut microbiota diversity and composition in the intervention group compared to the control group using 16SrRNA sequencing.
Measured: 3 months (post-intervention)
Exploratory outcome measurements (biogenic amines)
Differences in the concentration of biogenic amines in the intervention group compared to the control group.
Measured: 3 months (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start10 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Digestive Diseases Foundation, Sport Medisch Centrum Papendal, FormUpgrade, Arnhem, Sport Medisch Centrum, Jeroen Bosch Ziekenhuis
- Responsible party
- Sponsor
- Investigators
- Dr. M.J.M. Groenen, MD, PhD, Principal investigator, Gastroenterology department, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657197
- Sponsor's protocol ID
- NL81794.091.22
- Acronym
- ENERGIZE-IBD
- Status last verified
- Mar 2024
- First submitted
- 24 Oct 2022
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Erp LW, Roosenboom B, Komdeur P, Dijkstra-Heida W, Wisse J, Horjus Talabur Horje CS, Liem CS, van Cingel REH, Wahab PJ, Groenen MJM. Improvement of Fatigue and Quality of Life in Patients with Quiescent Inflammatory Bowel Disease Following a Personalized Exercise Program. Dig Dis Sci. 2021 Feb;66(2):597-604. doi: 10.1007/s10620-020-06222-5. Epub 2020 Apr 1.
PubMed 32239380
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENERGIZE IBD - The Effect of Intensive Physical Exercise on Fatigue and Quality of Life in Patients With Quiescent Inflammatory Bowel Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05657197
- Acronym / sponsor ID
- ENERGIZE-IBD / NL81794.091.22
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Fatigue, Exercise, Quality of life, IBD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Dutch Digestive Diseases Foundation, Sport Medisch Centrum Papendal, FormUpgrade, Arnhem, Sport Medisch Centrum, Jeroen Bosch Ziekenhuis
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Dec 2022 (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.
In patients with inflammatory bowel diseases (IBD), characterized by relapsing intestinal inflammation, chronic fatigue is a burdensome and highly prevalent symptom. The aetiology is thought to be multifactorial, including complex interactions of psychological and physical factors such as immunological profiles and gut microbiota. Unfortunately, specific treatment strategies are currently lacking. Since fatigued patients have an impaired physical fitness and are less physically active than patients without fatigue, it is hypothesised that physical exercise might be an effective complementary treatment for patients with IBD suffering from fatigue. During a previous pilot cohort study, significant improvements in fatigue complaints and quality of life were observed following a personalised and intensive exercise program. In this study, a multicenter randomized controlled trial will be performed to further investigate this assumed beneficial effect of intensive physical exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (exercise) group | Experimental | Behavioral: Exercise interventionThe patients in the intervention group will follow a personalised and intensive exercise program. |
| Control group | Other | Other: Usual careThe patients in the control group will receive usual care. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- ≥1 year diagnosis of IBD, including Crohn's disease (CD), ulcerative colitis (UC) and IBD-unclassified (IBD-U), based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria;
- Chronic fatigue complaints for at least 3 months;
- Severe fatigue complaints as confirmed with a score of ≥11 on section I of the inflammatory bowel disease fatigue self-assessment scale (IBD-F);
- Clinically quiescent IBD with a Harvey Bradshaw Index (HBI) <5 for Crohn's disease patients or a Simple Colitis Clinical Activity Index (SCCAI) ≤2 for patients with ulcerative colitis or IBD-unclassified;
- Faecal calprotectin <100 μg/g;
Key exclusion criteria (21 listed)
- Performing moderate-vigorous intensity exercise (i.e. swimming, running, cycling) more than once and/or >90 minutes per week in the past 3 months;
- Surgery within the past 6 months or planned surgery within 12 months after the screening visit;
- Participation in another intervention study;
- Pregnant at the moment of the screening visit or planning pregnancy within 12 months after the screening;
- Confirmed diagnosis of other causes of fatigue complaints, such as thyroid dysfunction, liver or renal failure, anaemia, folate-, iron-, vitamin B12- or D deficiency.
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 |
|---|---|---|
| Exercise interventionA 12-week exercise program consisting of three times per week 1-hour sessions, including 30-minutes aerobic- and 30-minutes progressive resistance training. The intensity of training will be adjusted to each individual, based on a cardiopulmonary exercise test. Training sessions will be performed in groups of 10 participants under supervision of a sports physical therapist. | Behavioural | Intervention (exercise) group |
| Usual careUsual care, including general advice concerning chronic fatigue. | Other | Control group |
Primary outcome
Change in fatigue (IBD-F), post-intervention
Time frame: 3 months (post-intervention)
Mean change in fatigue, measured with the inflammatory bowel disease fatigue self-assessment scale (IBD-F) 0-140 with higher scores indicating worse fatigue, in the intervention group compared to the control group.
Change in quality of life (IBDQ), post-intervention
Time frame: 3 months (post-intervention)
Mean change in quality of life, measured with the inflammatory bowel disease questionnaire (IBDQ) 32-224 with higher scores representing better quality of life, in the intervention group compared to the control group.
17 secondary outcomes
Long-term change in fatigue (IBD-F)
Time frame: 6- and 12-months
Long-term change in quality of life (IBDQ)
Time frame: 6- and 12-months
Change in cardiorespiratory fitness (maximum oxygen uptake)
Time frame: 3 months (post-intervention)
Change in cardiorespiratory fitness (maximum power)
Time frame: 3 months (post-intervention)
Change in muscular strength
Time frame: 3 months (post-intervention)
Change in body composition (BMI)
Time frame: 3 months (post-intervention)
Change in body composition (body fat percentage)
Time frame: 3 months (post-intervention)
Change in work absenteeism and presenteeism
Time frame: T= 3-, 6-, 9-, and 12-months
Disease activity (FCP)
Time frame: T= 3-, 6-, 9-, and 12-months
Disease activity (step-up therapy)
Time frame: T= 3-, 6-, 9-, and 12-months
Disease activity (exacerbation rate)
Time frame: T= 3-, 6-, 9-, and 12-months
Change in sleep quality
Time frame: T= 3-, 6-, 9-, and 12-months
Change in anxiety and depression symptoms
Time frame: T= 3-, 6-, 9-, and 12-months
Targeted cost-utility analysis
Time frame: 12 months
Exploratory outcome measurements (immunological profiles)
Time frame: 3 months (post-intervention)
Exploratory outcome measurements (gut microbiota)
Time frame: 3 months (post-intervention)
Exploratory outcome measurements (biogenic amines)
Time frame: 3 months (post-intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Background: PubMed 32239380van Erp LW, Roosenboom B, Komdeur P, Dijkstra-Heida W, Wisse J, Horjus Talabur Horje CS, Liem CS, van Cingel REH, Wahab PJ, Groenen MJM. Improvement of Fatigue and Quality of Life in Patients with Quiescent Inflammatory Bowel Disease Following a Personalized Exercise Program. Dig Dis Sci. 2021 Feb;66(2):597-604. doi: 10.1007/s10620-020-06222-5. Epub 2020 Apr 1.
- Individual participant dataSharing planned: No
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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.
Dr. M.J.M. Groenen, MD, PhD principal investigator
Gastroenterology department, Rijnstate Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Inflammatory Bowel Diseases, run by Rijnstate Hospital at 3 sites in Netherlands.
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 9 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Contact D Oomkens, MD MSc (088 - 005 6800, Energize_IBD@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue (IBD-F), post-intervention (time frame: 3 months (post-intervention)). The study lists 2 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 NCT05657197, which also lists 1 linked publication.
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 25 Mar 2024.