NCT06534138

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

10 months

First QC Date

March 25, 2024

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Six months

Study Arms (3)

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.

Behavioral: Physical exercise

Interventions

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.

Chronic Pancreatitis-exercise (CP-exercise)

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Clinical diagnosis of chronic pancreatitis
  • Must be adhere to the guidelines of the American Gastroenterological Association

You may not qualify if:

  • Autoimmune pancreatitis
  • Pancreatic cancer diagnosed within 2 years after the onset of CP
  • Use of drugs or toxins, or presence of viral infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

August 2, 2024

Study Start

May 18, 2023

Primary Completion

March 24, 2024

Study Completion

March 24, 2024

Last Updated

August 2, 2024

Record last verified: 2024-07

Locations