Special Physical Exercises as a Therapeutic Intervention for Inflammatory Bowel Disease

NCT04303260 | Completed

• 1 other identifier: 0277-18-TLV
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Clinical response as assessed by a change in PROMIS questionnaire

  PROMIS (Patient-Reported Outcomes Measurement Information System)

  After 4 weeks

• Clinical response as assessed by a change in QOL questionnaire

  Quality of life questionnaire

  After 4 weeks

Study Arms (2)

Interventional arm

ACTIVE COMPARATOR

Patients in the interventional arm will be asked to complete 3 different videos repeatedly, as many days a week as possible. This repetition is to be maintained even if a patient missed one day of training. 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.

Behavioral: Physical exercises

controled arm

PLACEBO COMPARATOR

Patients in the controled arm will also be asked to practice generally recommended exercises in 3 different videos repeatedly, as many sets as possible.. The control arm will practice generally recommended exercises, without particular attention to the abdomen.

Behavioral: Physical exercises

Interventions

Physical exercises BEHAVIORAL

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.

Interventional arm; controled arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \< 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Exercise

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nitsan Maharshak, MD

  Tel Aviv Medical Center- Head of Inflammatory Bowel Disease Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research and Development Department

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: March 11, 2020
• Study Start: July 8, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)