Inflammatory Bowel DiseasesPASIBONCT06106607
Physical Activity and Sedentary Behaviour in Patients With Inflammatory Bowel Disease
A study testing Intervention group in people with Inflammatory Bowel Diseases and Physical Activity, run by Center for Clinical Research and Prevention at 1 site in Denmark.
Trial summary
Emerging research suggests that physical activity may improve health-related quality of life (HrQoL) in patients with inflammatory bowel disease (IBD) and positively influence physical symptoms, fatigue, stress and anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Physical Activity, Sedentary Behavior
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2023to 3 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of IBD (Crohn's disease or ulcerative colitis) > 1 year
- Over 18 years of age
- Minimum three months stable medication type and dose without use of steroids as part of the medical treatment during the last three months
- Speak and understand Danish
Who cannot join
- Unable to give informed consent
- Active inflammatory disease in joints, skin, pancreas, thyroid, lungs or liver that can hinder engagement in physical activity and exercise
- Cognitive and/or mental disabilities that can hinder engagement in physical activity and exercise
- Engaging in high-intensity physical activity -/> 8 hours pr week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity and Sedentary Behaviour in Patients With Inflammatory Bowel Disease - Epidemiology and Interventions
Emerging research suggests that physical activity may improve health-related quality of life (HrQoL) in patients with inflammatory bowel disease (IBD) and positively influence physical symptoms, fatigue, stress and anxiety. However, little is known about detailed movement patterns and their specific health effects in IBD patients or about patients' wishes, motivation and preferences for physical activity in their everyday lives.
Based on exisiting evidence, the investigators' hypothesis is that an individually tailored, behavioural intervention focusing on reducing sedentary behaviour and increasing daily physical activity is feasible and effective in patients with IBD. Therefore, the overall aim of this randomized feasibility study is to determine the feasibility of the behavioural intervention, including the testing of recruitment procedures, intervention adherence, retention and outcome assessments.
Read more
Intervention participants will undergo:
- A group session with information about IBD and the effects and recommendations of physical activity and exercise
- Four motivational interviews with a project nurse, including goal-setting and action plans
- An optional part, where each participant will have the possibility of choosing between:
- An one-hour individual session with a physiotherapist
- Being teamed up with 1-2 'exercise buddies' (other intervention participants) and/or
- Access to four short 2-3 minutes videos/'reels' of a physiotherapist explaining and demonstrating beneficial physical exercises
Results from the present feasibility study will determine if and how to proceed with a large-scale randomized controlled trial evaluating the efficacy of the intervention.
Read the detailed description
Although existing literature indicates potential health benefits of physical activity and exercise in patients with IBD, there is little consistency in the proposed interventions for promoting physical activity, and large variations in the applied physical activity intensities and types in the existing physical activity intervention studies. Patients with IBD experience barriers to engaging in physical activity that are related to both stigmatization and disease symptoms. These are barriers that might be overcome if the physical intervention is focusing on variation in physical activity intensity and is tailored to the individual patient. The investigators' hypothesis is that an individually tailored, behavioural intervention focusing on physical activity in a 24-hour perspective, including sedentary behaviour and physical activity from light to vigorous intensity, is feasible and effective in patients with IBD.
The present feasibility study aims to test the behavioural intervention for feasibility and acceptability in a small sample (N=30) of patients with IBD from the gastroenterology outpatient clinic at Bispebjerg Hospital, Copenhagen, Denmark. By conducting a feasibility study with a small sample size, the investigators want to follow the course and applicability of an intervention that has been developed as an individual offer with possibilities and solutions for the individual patient, but still operated within a controlled and standardized research frame. Assessment of feasibility will include identification of barriers for recruitment, acceptance of group/randomization status, delivery methods, retention, outcome assessments and logistics. Outcome measures that will be tested for feasibility include objectively measured physical activity levels (over a 7-day period), health-related quality of life, fatigue, pain, mental health and cardio-metabolic biomarkers.
The intervention will address the individual patient's knowledge, motivation, resources and opportunities for reducing sedentary behaviour and increasing daily physical activity and exercise in the individual's everyday life.
The 20-week intervention will consist of a basic part for all participants, which will include
- A group session with education about IBD in general and about physical activity and exercise in relation to IBD (definitions, evidence and recommendations). Following this session, the participants will also be offered access to a video with general information about IBD, physical activity and exercise
- Four individual motivational counselling sessions (two physical and two telephone sessions) with a project nurse. The counselling sessions will involve identifying the individual's motivation and opportunities for increasing physical activity, behavioral goal setting and action planning.
An optional intervention part will then follow, where the individual participant will have the possibility of choosing between (or all of)
- A one-hour individual session with a physiotherapist from Bispebjerg/Frederiksberg Hospitals, which will involve guidance in physical activity and exercise tailored to the individual participant. This could be the case if a participant experiences specific symptoms or limitations when engaging in physical activity and/or exercise and needs individual guidance related to this.
- Being teamed up with 1-2 'exercise buddies' (other participants from the overall intervention group).
- Access to 4 short 2-3 minutes videos/'reels' of a physiotherapist explaining and demonstrating beneficial physical exercises. The videos aim to provide participants with new inspiration and practical suggestions to increase their physical activity and exercise.
The main setting of the intervention will be the participants' everyday lives (family, work/school, leisure-time activities). However, the Gastroenterology Department, Bispebjerg Hospital, and potentially, local municipal health centres and sports clubs will be the actual physical places for the specific intervention elements (e.g. education, counselling sessions, physiotherapist-led sessions, exercising in small communities ('exercise buddies').
Participants randomized to the control group will be encouraged to maintain their usual lifestyle and activities. They will be expected to undergo the same baseline - and outcome assessment as the participants in the intervention group.
Results from the present feasibility study will determine if and how to proceed with a large-scale randomized controlled trial evaluating the efficacy of the intervention.
- Being tested
- Intervention group
- Medical subject headings
- Inflammatory Bowel Diseases, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
A 20-week intervention with a basic part, including
- A group session with education about IBD,physical activity and exercise in relation to IBD (definitions, evidence and recommendations). Furthermore, access to a video with general information about IBD, physical activity and exercise
- Four individual motivational counselling sessions (two physical, two by telephone) with a project nurse. These will involve identifying individual motivation and opportunities for increasing physical activity and behavioral goal setting.
An optional intervention part will follow, including choises between (or all of)
- A one-hour individual session with a physiotherapist, involving guidance in physical activity and exercise tailored to the individual.
- Being teamed up with 1-2 'exercise buddies' (other participants from the overall intervention group).
- Access to 4 short 2-3 minutes videos/'reels' of a physiotherapist explaining and demonstrating beneficial physical exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group will undergo a 20-week individually tailored, behavioral intervention Receives: Behavioral: Intervention group |
| Control group | No intervention | This group will be encouraged to maintain usual lifestyle and activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment rates will be calculated as the proportion of patients randomised/proportion of patients eligible
Measured: Assessed at 3 months after baseline
Retention
Retention rates will be calculated as the proportion of patients providing the outcomes of interest/proportion of patients randomised
Measured: Assessed at 5 months (20 weeks)
Intervention adherence
Adherence to intervention protocol will be calculated as the number of group and motivational counselling sessions attended out of the total number of sessions available
Measured: Assessed at 5 months (20 weeks)
Intervention acceptability
Acceptability of intervention protocol will be calculated as the number of received optional elements of the intervention out of the total number of optional intervention elements available
Measured: Assessed at 5 months (20 weeks)
Secondary outcomes (18)
Objectively measured physical activity measured by SENS monitor
The SENS Motion sensor is an activity sensor, which captures seven-day, 24-hour physical activity patterns, including number of steps and the amount of daily time lying down, sitting, standing, and being active with light, moderate and high intensity, as well as specific activities such as bicycling or walking stairs
Measured: Assessed at baseline and at 5 months (20 weeks)
Self-reported physical activity and sitting time measured by the Physical Activity Scale (PAS)
Self-reported physical activity (light, moderate, vigorous) and sitting time at work and during leisure time will be measured by the Physical Activity Scale 2.1 (PAS 2.1). Participants will be asked to specify number of hours and minutes in an average 24-hour day spent sitting at work and during leisure time. In addition, participants will report number of weekly hours and minutes spent in light, moderate or vigorous intensity activities.
Measured: Assessed at baseline and at 5 months (20 weeks)
Exercise self-efficacy measured by the Exercise Self-Efficacy Scale
The Exercise Self-Efficacy Scale assesses an individual's beliefs in their ability to continue exercising under different circumstances.
Measured: Assessed at baseline and at 5 months (20 weeks)
Health-related quality of life measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
Quality of life will be measured by the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The IBDQ-32 captures the patient's experience of IBD on four domains of functioning and well-being: 1) bowel symptoms, 2) systemic symptoms, 3) emotional function and 4) social function.
Measured: Assessed at baseline and at 5 months (20 weeks)
Fatigue measured by The Multi-dimensional Fatigue Inventory (MFI-20)
Fatigue will be measured by the 20-item Multi-dimensional Fatigue Inventory (MFI 20) . MFI 20 consists of 20 statements, which classifies fatigue in five dimensions: 1) general fatigue 2) physical fatigue 3) mental fatigue 4) reduced activity 5) reduced motivation.
Measured: Assessed at baseline and at 5 months (20 weeks)
Fatigue measured by the visual analogue scale for fatigue (VAS-Fatigue)
Fatigue measured by the visual analogue scale for fatigue (VAS-fatigue). Score from 0-100. Higher score is more fatigue.
Measured: Assessed at baseline and at 5 months (20 weeks)
Pain intensity measured by the visual analogue scale for pain (VAS-Pain)
Pain will be measured by the visual analogue scale for pain. Score from 0-100. The higher score, the higher pain intensity.
Measured: Assessed at baseline and at 5 months (20 weeks)
Mental health measured by The Hospital Anxiety and Depression Scale (HADS) questionnaire
The HADS questionnaire consists of seven items for depression and anxiety subscales, respectively. Scoring for each item ranges from zero to three, with three indicating highest anxiety or depression level.
Measured: Assessed at baseline and at 5 months (20 weeks)
IBD-related disease activity measured by fecal calprotectin
Fecal calprotectin is a stool test that is used to detect inflammation in the intestines. It will be used to monitor the participants' disease activity and severity.
Measured: Assessed at baseline and at 5 months (20 weeks)
Serum lipids measured by blood sample
Total cholesterol, high-density lipoprotein cholesterol (HDL), and triglycerides will be measured by a blood sample. Low-density lipoprotein cholesterol (LDL) will be calculated.
Measured: Assessed at baseline and at 5 months (20 weeks)
Glycosylated hemoglobin (HbA1c) measured by blood sample
Glycosylated hemoglobin, type A1c (HbA1c) will be determined by a blood sample
Measured: Assessed at baseline and at 5 months (20 weeks)
Disease activity measured by a C-Reactive Protein (CRP) test
A venous blood sample will be drawn (not fasting)
Measured: Assessed at baseline and at 5 months (20 weeks)
Blood pressure measurements
Blood pressure will be measured, after 5 to 10 minutes of rest, 3 times at the right upper arm (average of the 3 measurements) with the participant in a sitting/lying position.
Measured: Assessed at baseline and at 5 months (20 weeks)
Body weight in kilograms
Body weight is measured in light clothing without shoes to the nearest 0.1 kg
Measured: Assessed at baseline and at 5 months (20 weeks)
Waist circumference measured in centimeters
Waist circumference will be measured midway between the lower rib margin and the iliac crest to the nearest 0.5 centimeter, without any pressure to the skin and with an unstretched tape measure.
Measured: Assessed at baseline and at 5 months (20 weeks)
Hip circumference measured in centimeters
Hip circumference will be measured at the point yielding the maximum circumference over the buttocks to the nearest 0.5 centimeter. The tape measure will be be held in a horizontal plane touching the skin but not indenting the soft tissue.
Measured: Assessed at baseline and at 5 months (20 weeks)
Waist-hip-ratio
Waist-hip-ratio will be calculated based on the assessments of waist and hip circumferences
Measured: Assessed at baseline and at 5 months (20 weeks)
Body mass Index (BMI)
Body mass Index (BMI, kg/m2) will be calculated based on the assessment of body weight and height.
Measured: Assessed at baseline and at 5 months (20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start15 Nov 2023
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Clinical Research and Prevention
- Sponsor type
- Research network
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Principal investigator, Tanja Thomsen, Center for Clinical Research and Prevention
- Investigators
- Mette Aadahl, PhD, Principal investigator, Professor at Center for Clinical Research and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106607
- Sponsor's protocol ID
- H-22040390
- Acronym
- PASIBO
- Status last verified
- Jan 2025
- First submitted
- 24 Oct 2023
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a feasibility study, sharing of outcome data is not relevant
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Sedentary Behaviour in Patients With Inflammatory Bowel Disease - Epidemiology and Interventions
- ClinicalTrials.gov ID
- NCT06106607
- Acronym / sponsor ID
- PASIBO / H-22040390
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Center for Clinical Research and PreventionResearch network
- Collaborators
- Bispebjerg Hospital
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 30 Oct 2023 (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.
Emerging research suggests that physical activity may improve health-related quality of life (HrQoL) in patients with inflammatory bowel disease (IBD) and positively influence physical symptoms, fatigue, stress and anxiety. However, little is known about detailed movement patterns and their specific health effects in IBD patients or about patients' wishes, motivation and preferences for physical activity in their everyday lives.
Based on exisiting evidence, the investigators' hypothesis is that an individually tailored, behavioural intervention focusing on reducing sedentary behaviour and increasing daily physical activity is feasible and effective in patients with IBD. Therefore, the overall aim of this randomized feasibility study is to determine the feasibility of the behavioural intervention, including the testing of recruitment procedures, intervention adherence, retention and outcome assessments.
Intervention participants will undergo:
- A group session with information about IBD and the effects and recommendations of physical activity and exercise
- Four motivational interviews with a project nurse, including goal-setting and action plans
- An optional part, where each participant will have the possibility of choosing between:
- An one-hour individual session with a physiotherapist
- Being teamed up with 1-2 'exercise buddies' (other intervention participants) and/or
- Access to four short 2-3 minutes videos/'reels' of a physiotherapist explaining and demonstrating beneficial physical exercises
Results from the present feasibility study will determine if and how to proceed with a large-scale randomized controlled trial evaluating the efficacy of the intervention.
Detailed description
Although existing literature indicates potential health benefits of physical activity and exercise in patients with IBD, there is little consistency in the proposed interventions for promoting physical activity, and large variations in the applied physical activity intensities and types in the existing physical activity intervention studies. Patients with IBD experience barriers to engaging in physical activity that are related to both stigmatization and disease symptoms. These are barriers that might be overcome if the physical intervention is focusing on variation in physical activity intensity and is tailored to the individual patient. The investigators' hypothesis is that an individually tailored, behavioural intervention focusing on physical activity in a 24-hour perspective, including sedentary behaviour and physical activity from light to vigorous intensity, is feasible and effective in patients with IBD.
The present feasibility study aims to test the behavioural intervention for feasibility and acceptability in a small sample (N=30) of patients with IBD from the gastroenterology outpatient clinic at Bispebjerg Hospital, Copenhagen, Denmark. By conducting a feasibility study with a small sample size, the investigators want to follow the course and applicability of an intervention that has been developed as an individual offer with possibilities and solutions for the individual patient, but still operated within a controlled and standardized research frame. Assessment of feasibility will include identification of barriers for recruitment, acceptance of group/randomization status, delivery methods, retention, outcome assessments and logistics. Outcome measures that will be tested for feasibility include objectively measured physical activity levels (over a 7-day period), health-related quality of life, fatigue, pain, mental health and cardio-metabolic biomarkers.
The intervention will address the individual patient's knowledge, motivation, resources and opportunities for reducing sedentary behaviour and increasing daily physical activity and exercise in the individual's everyday life.
The 20-week intervention will consist of a basic part for all participants, which will include
- A group session with education about IBD in general and about physical activity and exercise in relation to IBD (definitions, evidence and recommendations). Following this session, the participants will also be offered access to a video with general information about IBD, physical activity and exercise
- Four individual motivational counselling sessions (two physical and two telephone sessions) with a project nurse. The counselling sessions will involve identifying the individual's motivation and opportunities for increasing physical activity, behavioral goal setting and action planning.
An optional intervention part will then follow, where the individual participant will have the possibility of choosing between (or all of)
- A one-hour individual session with a physiotherapist from Bispebjerg/Frederiksberg Hospitals, which will involve guidance in physical activity and exercise tailored to the individual participant. This could be the case if a participant experiences specific symptoms or limitations when engaging in physical activity and/or exercise and needs individual guidance related to this.
- Being teamed up with 1-2 'exercise buddies' (other participants from the overall intervention group).
- Access to 4 short 2-3 minutes videos/'reels' of a physiotherapist explaining and demonstrating beneficial physical exercises. The videos aim to provide participants with new inspiration and practical suggestions to increase their physical activity and exercise.
The main setting of the intervention will be the participants' everyday lives (family, work/school, leisure-time activities). However, the Gastroenterology Department, Bispebjerg Hospital, and potentially, local municipal health centres and sports clubs will be the actual physical places for the specific intervention elements (e.g. education, counselling sessions, physiotherapist-led sessions, exercising in small communities ('exercise buddies').
Participants randomized to the control group will be encouraged to maintain their usual lifestyle and activities. They will be expected to undergo the same baseline - and outcome assessment as the participants in the intervention group.
Results from the present feasibility study will determine if and how to proceed with a large-scale randomized controlled trial evaluating the efficacy of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupThis group will undergo a 20-week individually tailored, behavioral intervention |
| Control group | No intervention | –This group will be encouraged to maintain usual lifestyle and activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A diagnosis of IBD (Crohn's disease or ulcerative colitis) > 1 year
- Over 18 years of age
- Minimum three months stable medication type and dose without use of steroids as part of the medical treatment during the last three months
- Speak and understand Danish
Key exclusion criteria (4 listed)
- Unable to give informed consent
- Active inflammatory disease in joints, skin, pancreas, thyroid, lungs or liver that can hinder engagement in physical activity and exercise
- Cognitive and/or mental disabilities that can hinder engagement in physical activity and exercise
- Engaging in high-intensity physical activity -/> 8 hours pr week
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 |
|---|---|---|
| Intervention groupA 20-week intervention with a basic part, including 1. A group session with education about IBD,physical activity and exercise in relation to IBD (definitions, evidence and recommendations). Furthermore, access to a video with general information about IBD, physical activity and exercise 2. Four individual motivational counselling sessions (two physical, two by telephone) with a project nurse. These will involve identifying individual motivation and opportunities for increasing physical activity and behavioral goal setting. An optional intervention part will follow, including choises between (or all of) 1. A one-hour individual session with a physiotherapist, involving guidance in physical activity and exercise tailored to the individual. 2. Being teamed up with 1-2 'exercise buddies' (other participants from the overall intervention group). 3. Access to 4 short 2-3 minutes videos/'reels' of a physiotherapist explaining and demonstrating beneficial physical exercises. | Behavioural | Intervention group |
Primary outcome
Recruitment
Time frame: Assessed at 3 months after baseline
Recruitment rates will be calculated as the proportion of patients randomised/proportion of patients eligible
Retention
Time frame: Assessed at 5 months (20 weeks)
Retention rates will be calculated as the proportion of patients providing the outcomes of interest/proportion of patients randomised
Intervention adherence
Time frame: Assessed at 5 months (20 weeks)
Adherence to intervention protocol will be calculated as the number of group and motivational counselling sessions attended out of the total number of sessions available
Intervention acceptability
Time frame: Assessed at 5 months (20 weeks)
Acceptability of intervention protocol will be calculated as the number of received optional elements of the intervention out of the total number of optional intervention elements available
18 secondary outcomes
Objectively measured physical activity measured by SENS monitor
Time frame: Assessed at baseline and at 5 months (20 weeks)
Self-reported physical activity and sitting time measured by the Physical Activity Scale (PAS)
Time frame: Assessed at baseline and at 5 months (20 weeks)
Exercise self-efficacy measured by the Exercise Self-Efficacy Scale
Time frame: Assessed at baseline and at 5 months (20 weeks)
Health-related quality of life measured by the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Assessed at baseline and at 5 months (20 weeks)
Fatigue measured by The Multi-dimensional Fatigue Inventory (MFI-20)
Time frame: Assessed at baseline and at 5 months (20 weeks)
Fatigue measured by the visual analogue scale for fatigue (VAS-Fatigue)
Time frame: Assessed at baseline and at 5 months (20 weeks)
Pain intensity measured by the visual analogue scale for pain (VAS-Pain)
Time frame: Assessed at baseline and at 5 months (20 weeks)
Mental health measured by The Hospital Anxiety and Depression Scale (HADS) questionnaire
Time frame: Assessed at baseline and at 5 months (20 weeks)
IBD-related disease activity measured by fecal calprotectin
Time frame: Assessed at baseline and at 5 months (20 weeks)
Serum lipids measured by blood sample
Time frame: Assessed at baseline and at 5 months (20 weeks)
Glycosylated hemoglobin (HbA1c) measured by blood sample
Time frame: Assessed at baseline and at 5 months (20 weeks)
Disease activity measured by a C-Reactive Protein (CRP) test
Time frame: Assessed at baseline and at 5 months (20 weeks)
Blood pressure measurements
Time frame: Assessed at baseline and at 5 months (20 weeks)
Body weight in kilograms
Time frame: Assessed at baseline and at 5 months (20 weeks)
Waist circumference measured in centimeters
Time frame: Assessed at baseline and at 5 months (20 weeks)
Hip circumference measured in centimeters
Time frame: Assessed at baseline and at 5 months (20 weeks)
Waist-hip-ratio
Time frame: Assessed at baseline and at 5 months (20 weeks)
Body mass Index (BMI)
Time frame: Assessed at baseline and at 5 months (20 weeks)
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 30 Jan 2025.
- Individual participant dataSharing planned: No. As this is a feasibility study, sharing of outcome data is not relevant
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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.
Mette Aadahl, PhD principal investigator
Professor at Center for Clinical Research and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Inflammatory Bowel Diseases and Physical Activity, run by Center for Clinical Research and Prevention at 1 site in Denmark.
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 4 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: finished, as of the sponsor's last update on 30 Jan 2025. 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 Denmark. 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?
Recruitment (time frame: Assessed at 3 months after baseline). The study lists 4 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 30 Jan 2025.