FatigueNCT04189692
Evolution of Fatigue in Patients With Inflammatory Bowel Disease
An observational study of Fatigue and Inflammatory Bowel Diseases, run by Corporacion Parc Tauli.
Trial summary
The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in two previous studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Inflammatory Bowel Diseases, Crohn Disease
- How many people
- 202 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2020to 7 Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with IBD and fatigue included in the two previous studies (1,2) (n = 202) who agree to participate.
Who may be able to join
- Patients with inflammatory bowel disease and fatigue (defined as a FACIT-F score <40 points) previously documented in our two previous studies.
- Written informed consent after receiving clear and objective information about the purpose and characteristics of the study.
- Ability to understand the questionnaires.
Who cannot join
- Associated tumor disease.
- Pregnancy or breastfeeding.
- Anemia (hemoglobin <12g/dl in women and 14g/dl in men)
- Any concomitant illness that may justify the presence of fatigue.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in two previous studies.
Read the detailed description
Fatigue is a common symptom in inflammatory bowel disease and persists despite clinical remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F scale.
Recent publications have tried to assess the prevalence and factors related to fatigue in patients with IBD.
In 2017 one study evaluated the prevalence and predictive factors of fatigue in out-patients with inflammatory bowel disease. Fatigue was associated with depression, low quality of life and female sex. No association was found with micronutrients or levels of interleukins.
As there are no effective treatments for fatigue in IBD, another study, recently published a study evaluating the role of electroacupuncture in 54 patients with quiescent IBD and fatigue, observing that both electroacupuncture and sham acupuncture improved fatigue compared to the control group.
The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in the two previous studies.
Patients with inflammatory bowel disease and fatigue (FACIT-F score < 40) included in these two previous studies who agree to participate will fill in questionnaires to assess fatigue, anxiety, depression and quality of life in inflammatory bowel disease. Moreover, the relationship of other biological factors with IBD-related fatigue will be determined.
- Keywords
- Fatigue;, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- Medical subject headings
- Fatigue, Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Inflammatory Bowel Disease and fatigue | Patients with Inflammatory Bowel Disease and fatigue that participated in the two studies (1,2). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the evolution of fatigue in patients with Inflammatory Bowel Disease at 3 years
Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F scale). This questionnaire, previously validated in Spanish and for IBD patients, comprises 40 items divided into five subscales: Physical wellbeing (PWB), Social/family wellbeing (SWB), Emotional wellbeing (EWB), Functional Wellbeing (FWB), and Fatigue subscale. The first four subscales (27 items) evaluate general features of chronic illness, and the 13 items of the Fatigue subscale specifically focus on fatigue. Each item has five possible answers, from 0 (very fatigued) to 4 (not at all fatigued). The score of each subscale is the sum of the coded values of its items.
Measured: three years
Secondary outcomes (3)
Assess the biological factors associated with the persistence of fatigue
Assessed by a blood test including micronutrients (vitamin B12, ferritin and vitamin D).
Measured: three years
Assess the psychological factors associated with the persistence of fatigue
Assessed by the Beck Depression Inventory (BDI) questionnaire. The Spanish validated 21-item version of the BDI will be used to analyze depression. This self-administered questionnaire evaluates the clinical features of melancholy and intrusive thoughts present in depression. Each item has a different number of options (from 4 to 8), which then have to be converted into four possible values (0, 1, 2, or 3). Higher BDI scores indicate a higher grade of depression.
Measured: three years
Assess the psychological factors associated with the persistence of fatigue
Assessed by Quality of life in inflammatory bowel disease questionnaire (IBDQ-9). he IBDQ-9 consists of nine items assessing different aspects of life in IBD patients. Each item has seven different possible answers, scoring from 1 (poorest) to 7 (best). The straight summation of all nine items provides a direct score, which is then transformed into a final score. Higher scores correspond to a better quality of life.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start7 Jan 2020 (estimated)
- Primary completion7 Dec 2020 (estimated)
- Study completion7 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Horta-Sangenis, Corporacion Parc Tauli
- Investigators
- Diana Horta, Principal investigator, Parc Tauli Hospital. Sabadell , Barcelona, Spain, 08208
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189692
- Sponsor's protocol ID
- HMT3
- Status last verified
- Dec 2019
- First submitted
- 14 Nov 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Villoria A, Garcia V, Dosal A, Moreno L, Montserrat A, Figuerola A, Horta D, Calvet X, Ramirez-Lazaro MJ. Fatigue in out-patients with inflammatory bowel disease: Prevalence and predictive factors. PLoS One. 2017 Jul 27;12(7):e0181435. doi: 10.1371/journal.pone.0181435. eCollection 2017.
PubMed 28749985Horta D, Lira A, Sanchez-Lloansi M, Villoria A, Teggiachi M, Garcia-Rojo D, Garcia-Molina S, Figuerola A, Esteve M, Calvet X. A Prospective Pilot Randomized Study: Electroacupuncture vs. Sham Procedure for the Treatment of Fatigue in Patients With Quiescent Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 Feb 11;26(3):484-492. doi: 10.1093/ibd/izz091.
PubMed 31091322
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Fatigue in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04189692
- Acronym / sponsor ID
- HMT3
- Keywords
- Fatigue;, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 7 Jan 2020 (estimated)
- Primary completion
- 7 Dec 2020 (estimated)
- Study completion
- 7 Dec 2020 (estimated)
- First posted
- 6 Dec 2019 (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.
The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in two previous studies.
Detailed description
Fatigue is a common symptom in inflammatory bowel disease and persists despite clinical remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F scale.
Recent publications have tried to assess the prevalence and factors related to fatigue in patients with IBD.
In 2017 one study evaluated the prevalence and predictive factors of fatigue in out-patients with inflammatory bowel disease. Fatigue was associated with depression, low quality of life and female sex. No association was found with micronutrients or levels of interleukins.
As there are no effective treatments for fatigue in IBD, another study, recently published a study evaluating the role of electroacupuncture in 54 patients with quiescent IBD and fatigue, observing that both electroacupuncture and sham acupuncture improved fatigue compared to the control group.
The aim of this study is to evaluate the evolution and possible factors associated with the persistence of fatigue in patients with quiescent IBD and fatigue included in the two previous studies.
Patients with inflammatory bowel disease and fatigue (FACIT-F score < 40) included in these two previous studies who agree to participate will fill in questionnaires to assess fatigue, anxiety, depression and quality of life in inflammatory bowel disease. Moreover, the relationship of other biological factors with IBD-related fatigue will be determined.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Inflammatory Bowel Disease and fatigue | – | –Patients with Inflammatory Bowel Disease and fatigue that participated in the two studies (1,2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with IBD and fatigue included in the two previous studies (1,2) (n = 202) who agree to participate.
Key inclusion criteria (3 listed)
- Patients with inflammatory bowel disease and fatigue (defined as a FACIT-F score <40 points) previously documented in our two previous studies.
- Written informed consent after receiving clear and objective information about the purpose and characteristics of the study.
- Ability to understand the questionnaires.
Key exclusion criteria (4 listed)
- Associated tumor disease.
- Pregnancy or breastfeeding.
- Anemia (hemoglobin <12g/dl in women and 14g/dl in men)
- Any concomitant illness that may justify the presence of fatigue.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the evolution of fatigue in patients with Inflammatory Bowel Disease at 3 years
Time frame: three years
Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F scale). This questionnaire, previously validated in Spanish and for IBD patients, comprises 40 items divided into five subscales: Physical wellbeing (PWB), Social/family wellbeing (SWB), Emotional wellbeing (EWB), Functional Wellbeing (FWB), and Fatigue subscale. The first four subscales (27 items) evaluate general features of chronic illness, and the 13 items of the Fatigue subscale specifically focus on fatigue. Each item has five possible answers, from 0 (very fatigued) to 4 (not at all fatigued). The score of each subscale is the sum of the coded values of its items.
3 secondary outcomes
Assess the biological factors associated with the persistence of fatigue
Time frame: three years
Assess the psychological factors associated with the persistence of fatigue
Time frame: three years
Assess the psychological factors associated with the persistence of fatigue
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Background: PubMed 28749985Villoria A, Garcia V, Dosal A, Moreno L, Montserrat A, Figuerola A, Horta D, Calvet X, Ramirez-Lazaro MJ. Fatigue in out-patients with inflammatory bowel disease: Prevalence and predictive factors. PLoS One. 2017 Jul 27;12(7):e0181435. doi: 10.1371/journal.pone.0181435. eCollection 2017.
- Background: PubMed 31091322Horta D, Lira A, Sanchez-Lloansi M, Villoria A, Teggiachi M, Garcia-Rojo D, Garcia-Molina S, Figuerola A, Esteve M, Calvet X. A Prospective Pilot Randomized Study: Electroacupuncture vs. Sham Procedure for the Treatment of Fatigue in Patients With Quiescent Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 Feb 11;26(3):484-492. doi: 10.1093/ibd/izz091.
- Individual participant dataSharing planned: No
Related trials for Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
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.
Diana Horta principal investigator
Parc Tauli Hospital. Sabadell , Barcelona, Spain, 08208
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Inflammatory Bowel Diseases, run by Corporacion Parc Tauli.
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 3 inclusion and 4 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 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Diana Horta (93 745 84 54, diana.horta.s@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the evolution of fatigue in patients with Inflammatory Bowel Disease at 3 years (time frame: three years). 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 NCT04189692, which also lists 2 linked publications.
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 6 Dec 2019.