Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)NCT07916493
Effects of Different Physical Activity Strategies on Disease Activity of IBD Patients
A study testing Pilates and Combined Resistance and Aerobic Training in people with Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), run by Szeged University.
Trial summary
The goal of this randomized controlled trial is to evaluate the effects of two different exercise programs, Pilates and combined resistance and aerobic training, on physical activity, kinesiophobia, quality of life, and disease-related outcomes in adults with inflammatory bowel disease (IBD), including Crohn's disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
- What is being tested?
- Pilates and Combined Resistance and Aerobic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- • Age >18 years
- Confirmed diagnosis of IBD
- Signed informed consent
Who cannot join
- • Presence of comorbidities
- History of traumatic event
About this study
The goal of this randomized controlled trial is to evaluate the effects of two different exercise programs, Pilates and combined resistance and aerobic training, on physical activity, kinesiophobia, quality of life, and disease-related outcomes in adults with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.
The main questions it aims to answer are:
Read more
- Do the two exercise programs improve physical activity levels, reduce kinesiophobia, and improve quality of life in adults with IBD?
- Are there differences between Pilates and combined resistance and aerobic training in their effects on participants' health status and disease-related outcomes?
Researchers will compare participants assigned to the Pilates group and the combined resistance and aerobic training group with participants in the control group to evaluate the effects of the exercise programs.
Participants will be randomly allocated to one of three groups: a Pilates group, a combined resistance and aerobic training group, or a control group. Participants in the exercise groups will follow their assigned exercise program using online instructional videos twice a week for 12 weeks, with each session lasting 20-30 minutes. They will record completed exercise sessions in an exercise diary. All participants will complete questionnaires before and after the intervention to assess physical activity, kinesiophobia, quality of life, depressive symptoms, knowledge of physical activity, and attitudes towards physiotherapists. Relevant demographic and clinical data will also be collected from medical records.
- Being tested
- Pilates, Combined Resistance and Aerobic Training
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilatesOther
The interventions in this study are distinguished by the use of two different physiotherapist-designed, structured exercise programs delivered through online instructional videos to adults with inflammatory bowel disease (IBD). Both programs will be performed twice weekly for 12 weeks, with each session lasting 20-30 minutes.
The Pilates intervention emphasizes controlled movements, breathing techniques, postural correction, stability, mobility, and strengthening of the abdominal, back, and gluteal muscles.
Combined Resistance and Aerobic TrainingOther
The interventions in this study are distinguished by the use of two different physiotherapist-designed, structured exercise programs delivered through online instructional videos to adults with inflammatory bowel disease (IBD). Both programs will be performed twice weekly for 12 weeks, with each session lasting 20-30 minutes. The combined resistance and aerobic training intervention includes strengthening exercises targeting all major muscle groups, using body weight and everyday household items, with exercises performed at varying intensities and instructions for manual heart rate monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Active comparator | Not described Receives: Other: Pilates |
| Combined Resistance and Aerobic Training Group | Active comparator | Not described Receives: Other: Combined Resistance and Aerobic Training |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in kinesiophobia level
Change in kinesiophobia level from baseline to the end of the 12-week intervention, assessed using the Tampa Scale of Kinesiophobia (TSK). Changes in kinesiophobia will be compared between the Pilates group, the combined resistance and aerobic training group, and the control group.
Measured: Baseline and at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)Studies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916493
- Sponsor's protocol ID
- BM/27870-3/2024
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Physical Activity Strategies on Disease Activity of IBD Patients
- ClinicalTrials.gov ID
- NCT07916493
- Acronym / sponsor ID
- BM/27870-3/2024
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 4 Nov 2026 (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 goal of this randomized controlled trial is to evaluate the effects of two different exercise programs, Pilates and combined resistance and aerobic training, on physical activity, kinesiophobia, quality of life, and disease-related outcomes in adults with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.
The main questions it aims to answer are:
- Do the two exercise programs improve physical activity levels, reduce kinesiophobia, and improve quality of life in adults with IBD?
- Are there differences between Pilates and combined resistance and aerobic training in their effects on participants' health status and disease-related outcomes?
Researchers will compare participants assigned to the Pilates group and the combined resistance and aerobic training group with participants in the control group to evaluate the effects of the exercise programs.
Participants will be randomly allocated to one of three groups: a Pilates group, a combined resistance and aerobic training group, or a control group. Participants in the exercise groups will follow their assigned exercise program using online instructional videos twice a week for 12 weeks, with each session lasting 20-30 minutes. They will record completed exercise sessions in an exercise diary. All participants will complete questionnaires before and after the intervention to assess physical activity, kinesiophobia, quality of life, depressive symptoms, knowledge of physical activity, and attitudes towards physiotherapists. Relevant demographic and clinical data will also be collected from medical records.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Active comparator | Other: Pilates |
| Combined Resistance and Aerobic Training Group | Active comparator | Other: Combined Resistance and Aerobic Training |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age >18 years
Key exclusion criteria (2 listed)
- • Presence of comorbidities
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 |
|---|---|---|
| PilatesThe interventions in this study are distinguished by the use of two different physiotherapist-designed, structured exercise programs delivered through online instructional videos to adults with inflammatory bowel disease (IBD). Both programs will be performed twice weekly for 12 weeks, with each session lasting 20-30 minutes. The Pilates intervention emphasizes controlled movements, breathing techniques, postural correction, stability, mobility, and strengthening of the abdominal, back, and gluteal muscles. | Other | Pilates Group |
| Combined Resistance and Aerobic TrainingThe interventions in this study are distinguished by the use of two different physiotherapist-designed, structured exercise programs delivered through online instructional videos to adults with inflammatory bowel disease (IBD). Both programs will be performed twice weekly for 12 weeks, with each session lasting 20-30 minutes. The combined resistance and aerobic training intervention includes strengthening exercises targeting all major muscle groups, using body weight and everyday household items, with exercises performed at varying intensities and instructions for manual heart rate monitoring. | Other | Combined Resistance and Aerobic Training Group |
Primary outcome
Change in kinesiophobia level
Time frame: Baseline and at 12 weeks
Change in kinesiophobia level from baseline to the end of the 12-week intervention, assessed using the Tampa Scale of Kinesiophobia (TSK). Changes in kinesiophobia will be compared between the Pilates group, the combined resistance and aerobic training group, and the control group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Related trials for Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
Not yet recruitingObservational study
Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Frailty
RecruitingObservational study
Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
Inflammatory Bowel Disease (IBD), Crohn's Disease
RecruitingPhase 2/3
Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Chronic Fatigue
Not yet recruiting
A Mindfulness-based Stress Reduction Program for IBD
Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates and Combined Resistance and Aerobic Training in people with Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), run by Szeged University.
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 2 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in kinesiophobia level (time frame: Baseline and at 12 weeks). 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 4 Nov 2026.