Special Physical Exercises as a Therapeutic Intervention for Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Special Physical Exercises as a Therapeutic Intervention for Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04303260
• Other study ID #: 0277-18-TLV
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Naomi Fliss, PhD
• Phone: 97236974924
• Email: naomifl[@]tlvmc.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Inflammatory Bowel Disease or a control set of unrelated exercises. Patients will be randomized to either interventional or control groups by a computer automatized randomization program. Patients will be sent an email with the link to an internet site where they will be able to watch the exercise program. The interventional exercise regimen will include specific exercises postulated to increase blood flow to the intestine and colon and thereby promote normal peristaltic and decrease inflammation. The control arm will practice generally recommended exercises, without particular attention to the abdomen. Videos of sets of exercise will be available online which patients will be able to watch and follow from their home computer. The exercise regimens (both interventional and controls) will be sequenced and performed by a trained and experienced instructor, which will provide these to the PI. Each video will include explicit instructions and examples for each of the exercises. Patients will be asked to watch the videos and preform the exercises individually every day. Patients in the interventional arm will be asked to complete 3 different videos repeatedly, as many days a week sets as possible. This repetition is to be maintained even if a patient missed one day of training to perform sets of 15 minutes/ day, 6 times a week.; Compliance will be documented by patients through emails to the study coordinator. Patients in the controled arm will also be asked to practice generally recommended exercises in 3 different videos repeatedly, as many sets as possible. Patients will answer questionnaires once every two weeks(week 0, 2, 4). Patients will answer QOL(quality of life), PROMs(Patient Reported Outcome Measures),disease activity , Sleep questionnaire and Morningness eveningness questionnaire. Also, before and after the intervention (week 0 and week 4) patients will visit the clinic for anthropometric measurements and to give serum, stool and urine sample which will be analyzed for inflammatory markers, microbial composition and function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 18 < age < 60

2. 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.

3. CD patients will be included if their symptoms score 5= between =15 on the Harvey-Bradshaw index (HBI) score

4. UC patients will be included if their symptoms score 3=between=9 on the Simple Clinical Colitis Activity Index (SCCAI)

Exclusion Criteria:

1. Inability to commit for performing at least 15 minutes of exercise, 6 times a week

2. Lack of availability or capability to use a computer/ internet.

3. Any proven current infection such as Clostridium difficile infection, positive stool culture, or parasites.

4. Inability to sign informed consent and complete study protocol

5. Pregnancy

6. Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD.

7. Patients with ileostomy, pouch or short bowel

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

Behavioral:
• Physical exercises
The interventional exercise regimen will include specific exercises postulated to increase blood flow to the intestine and colon and thereby promote normal peristaltic s and decrease inflammation.

Locations

Country	Name	City	State
Israel	Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response assessed by a change in HBI	Doctor evaluation -The Harvey-Bradshaw index activity index; Harvey Bradshaw Index (based on the day before): General well-being: very well =0; slightly below par =1; poor =2; very poor =3; terrible =4; Abdominal pain: none =0; mild =1; moderate =2; severe =3; Abdominal mass: none =0; dubious =1; definite =2; definite and tender =3; Number of liquid stools per day: Complications: none =0; arthralgia =1; uveitis =1; erythema nodosum =1; aphthous ulcers =1; pyoderma gangrenosum =1; anal fissure =1; new fistula =1; abscess =1; SCORE: <5 Remission 5-7 Mild activity 8-16 Moderate activity >16 Sever activity	After 4 weeks
Primary	Clinical response as assessed by a change in SCCAI	Doctor evaluation- Simple Clinical Colitis Activity Index; Bowel frequency (day): 0-3 / day (0); 4-6 / day (1); 7-9 / day (2); >9 / day (3); Bowel frequency (night): 0 / night (0); 1-3 / night (1); 4-6 / night (2); General well being: very well (0); slightly below par (1); poor (2); very poor (3); terrible (4); Urgency of defecation: none (0); Hurry (1); Immediately (toilet nearby) (2); Incontinence (3); Blood in stool: None (0); Trace (1); Occasionally (<50% of defecations) (2); Usually (>50% of defecations) (3); SCCAI Score: (add scores of questions 1 to 5) Remission<3 Mild Disease 3-5 Moderate Disease 6-9 Severe Disease =10	After 4 weeks
Primary	Clinical response as assessed by a change in PROMIS questionnaire	PROMIS (Patient-Reported Outcomes Measurement Information System)	After 4 weeks
Primary	Clinical response as assessed by a change in QOL questionnaire	Quality of life questionnaire	After 4 weeks