Chronic PancreatitisNCT06534138
Exercise Inhibit Innate Immune Response and Ameliorate Chronic Pancreatitis
An observational study of Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the effects of different physical exercise on disease progression in patients with chronic pancreatitis. The main question it aims to answer is: Can physical exercise alleviate the disease progression of chronic pancreatitis? Currently, the investigators have… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Physical exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2023to 24 Mar 2024
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The 105 patients with CP were categorized into the sedentary group (CP-Sed, n = 54) and exercise group (CP-Ex, n = 51) based on self-reported exercise time per day during the six-month follow-up post the diagnosis of CP. Physical exercise time was recorded at four levels: 15 min/d, 30 min/d, 45 min/d, and 60 min/d or more.
Who may be able to join
- Clinical diagnosis of chronic pancreatitis
- Must be adhere to the guidelines of the American Gastroenterological Association
Who cannot join
- Autoimmune pancreatitis
- Pancreatic cancer diagnosed within 2 years after the onset of CP
- Use of drugs or toxins, or presence of viral infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study on the Role of Exercise in the Disease Progression of Chronic Pancreatitis.
The goal of this observational study is to learn about the effects of different physical exercise on disease progression in patients with chronic pancreatitis. The main question it aims to answer is:
Can physical exercise alleviate the disease progression of chronic pancreatitis?
Currently, the investigators have followed up with participants through a telephone questionnaire for six months to investigate whether the participants have engaged in physical exercise and to assess the disease progression of chronic pancreatitis.
- Conditions
- Chronic Pancreatitis
- Being tested
- Physical exercise
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseBehavioural
The CP-exercise group was categorized based on patients' self-reported daily exercise time into four levels: 15 minutes/day, 30 minutes/day, 45 minutes/day, and ≥60 minutes/day. Additionally, resistance exercise and endurance exercise were distinguished based on patients' self-reported exercise modalities, including swimming, jogging, brisk walking, practicing Tai Chi, and dumbbell training.
| Study group | Role | What they receive |
|---|---|---|
| Non-Chronic Pancreatitis (Non-CP) | Patients diagnosed without chronic pancreatitis based on imaging results were categorized into the Non-CP group. | |
| Chronic Pancreatitis-non-exercise (CP-non-exercise) | Patients diagnosed with chronic pancreatitis based on imaging results, while simultaneously not engaging in physical exercise, were categorized into the CP-non-exercise group. | |
| Chronic Pancreatitis-exercise (CP-exercise) | Patients diagnosed with chronic pancreatitis based on imaging results, while concurrently adhering to physical exercise, were categorized into the CP-exercise group. Receives: Behavioral: Physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Exercise Can Alleviate the Disease Progression of Chronic Pancreatitis.
The investigators collected data on patients' exercise time and modalities through telephone questionnaires. The impact of exercise on patients with chronic pancreatitis was determined by assessing VAS scores.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start18 May 2023
- Primary completion24 Mar 2024
- Study completion24 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534138
- Sponsor's protocol ID
- Exercise
- Status last verified
- Jul 2024
- First submitted
- 25 Mar 2024
- Last updated
- 2 Aug 2024
- 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Role of Exercise in the Disease Progression of Chronic Pancreatitis.
- ClinicalTrials.gov ID
- NCT06534138
- Acronym / sponsor ID
- Exercise
- Conditions
- Chronic Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 24 Mar 2024 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 2 Aug 2024 (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 observational study is to learn about the effects of different physical exercise on disease progression in patients with chronic pancreatitis. The main question it aims to answer is:
Can physical exercise alleviate the disease progression of chronic pancreatitis?
Currently, the investigators have followed up with participants through a telephone questionnaire for six months to investigate whether the participants have engaged in physical exercise and to assess the disease progression of chronic pancreatitis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Chronic Pancreatitis (Non-CP) | – | –Patients diagnosed without chronic pancreatitis based on imaging results were categorized into the Non-CP group. |
| Chronic Pancreatitis-non-exercise (CP-non-exercise) | – | –Patients diagnosed with chronic pancreatitis based on imaging results, while simultaneously not engaging in physical exercise, were categorized into the CP-non-exercise group. |
| Chronic Pancreatitis-exercise (CP-exercise) | – | Behavioral: Physical exercisePatients diagnosed with chronic pancreatitis based on imaging results, while concurrently adhering to physical exercise, were categorized into the CP-exercise group. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The 105 patients with CP were categorized into the sedentary group (CP-Sed, n = 54) and exercise group (CP-Ex, n = 51) based on self-reported exercise time per day during the six-month follow-up post the diagnosis of CP. Physical exercise time was recorded at four levels: 15 min/d, 30 min/d, 45 min/d, and 60 min/d or more.
Key inclusion criteria (2 listed)
- Clinical diagnosis of chronic pancreatitis
- Must be adhere to the guidelines of the American Gastroenterological Association
Key exclusion criteria (3 listed)
- Autoimmune pancreatitis
- Pancreatic cancer diagnosed within 2 years after the onset of CP
- Use of drugs or toxins, or presence of viral infections
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 |
|---|---|---|
| Physical exerciseThe CP-exercise group was categorized based on patients' self-reported daily exercise time into four levels: 15 minutes/day, 30 minutes/day, 45 minutes/day, and ≥60 minutes/day. Additionally, resistance exercise and endurance exercise were distinguished based on patients' self-reported exercise modalities, including swimming, jogging, brisk walking, practicing Tai Chi, and dumbbell training. | Behavioural | Chronic Pancreatitis-exercise (CP-exercise) |
Primary outcome
Physical Exercise Can Alleviate the Disease Progression of Chronic Pancreatitis.
Time frame: Six months
The investigators collected data on patients' exercise time and modalities through telephone questionnaires. The impact of exercise on patients with chronic pancreatitis was determined by assessing VAS scores.
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 2 Aug 2024.
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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?
An observational study of Chronic Pancreatitis, run by Changhai Hospital at 1 site in China.
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 2 Aug 2024. 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 China. 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?
Physical Exercise Can Alleviate the Disease Progression of Chronic Pancreatitis. (time frame: Six months). 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 2 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.