Status:
COMPLETED
Special Physical Exercises as a Therapeutic Intervention for Inflammatory Bowel Disease
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The investigator is hypothesize that physical activity can have positive effects on health, general well-being , sleep quality and stress in Inflammatory Bowel Disease patients.
Detailed Description
A randomized-controlled-double blinded pilot study. 50 Inflammatory Bowel Disease patients, suffering from mild disease will be randomized to undergo either a set of specific physical exercises for In...
Eligibility Criteria
Inclusion
- 18 \< age \< 60
- Clinically stable patients, constant medicinal regimen throughout the study period. Refractory to mesalamine at least 6 weeks, or steroids at least 2 week, or immunomodulator at least 12 weeks or biologics at least 12 weeks therapy, medical cannabis at least 2 weeks before the study.
- CD patients will be included if their symptoms score 5≤ between ≤15 on the Harvey-Bradshaw index (HBI) score
- UC patients will be included if their symptoms score 3≤between≤9 on the Simple Clinical Colitis Activity Index (SCCAI)
Exclusion
- Inability to commit for performing at least 15 minutes of exercise, 6 times a week
- Lack of availability or capability to use a computer/ internet.
- Any proven current infection such as Clostridium difficile infection, positive stool culture, or parasites.
- Inability to sign informed consent and complete study protocol
- Pregnancy
- Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD.
- Patients with ileostomy, pouch or short bowel
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04303260
Start Date
July 8 2019
End Date
August 1 2024
Last Update
February 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel