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Special Physical Exercises as a Therapeutic Intervention for Inflammatory Bowel Disease

Primary Purpose

Crohn Disease, Ulcerative Colitis

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Physical exercises
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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 4<between <7 on the Harvey-Bradshaw index (HBI) score
  4. UC patients will be included if their symptoms score >5between <8 on the 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

Sites / Locations

  • Dep. of Gastroenterology, Tel Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Interventional arm

controled arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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<5 Mild Disease 5-7 Moderate Disease 8-11 Severe Disease >11
Clinical response as assessed by a change in PROMIS questionnaire
PROMIS (Patient-Reported Outcomes Measurement Information System)
Clinical response as assessed by a change in QOL questionnaire
Quality of life questionnaire

Secondary Outcome Measures

Full Information

First Posted
July 1, 2019
Last Updated
January 30, 2022
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04303260
Brief Title
Special Physical Exercises as a Therapeutic Intervention for Inflammatory Bowel Disease
Official Title
Special Physical Exercises as a Therapeutic Intervention for Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
controled arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical response assessed by a change in HBI
Description
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
Time Frame
After 4 weeks
Title
Clinical response as assessed by a change in SCCAI
Description
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<5 Mild Disease 5-7 Moderate Disease 8-11 Severe Disease >11
Time Frame
After 4 weeks
Title
Clinical response as assessed by a change in PROMIS questionnaire
Description
PROMIS (Patient-Reported Outcomes Measurement Information System)
Time Frame
After 4 weeks
Title
Clinical response as assessed by a change in QOL questionnaire
Description
Quality of life questionnaire
Time Frame
After 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 4<between <7 on the Harvey-Bradshaw index (HBI) score UC patients will be included if their symptoms score >5between <8 on the SCCAI Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naomi Fliss, PhD
Phone
97236974924
Email
naomifl@tlvmc.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Sorek, MS
Phone
03-6972428
Email
michalsor@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitsan Maharshak, MD
Organizational Affiliation
Tel Aviv Medical Center- Head of Inflammatory Bowel Disease Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitsan Maharshak, PhD
Phone
972-3-6947305
Email
nitsanm@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Nitsan Maharshak, MD
First Name & Middle Initial & Last Name & Degree
Naomi Fliss Isakov, PhD
First Name & Middle Initial & Last Name & Degree
Nathaniel Aviv Cohen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Special Physical Exercises as a Therapeutic Intervention for Inflammatory Bowel Disease

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