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Crohn DiseaseNCT04303260

Special Physical Exercises as a Therapeutic Intervention for Inflammatory Bowel Disease

A study testing Physical exercises in people with Crohn Disease and Ulcerative Colitis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Crohn Disease, Ulcerative Colitis
What is being tested?
Physical exercises
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteIsrael
Study dates
8 Jul 2019to 1 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

About this study

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.

Read the 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.

Being tested
Physical exercises
Medical subject headings
Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exercisesBehavioural

    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.

Study groups in NCT04303260
Study groupRoleWhat they receive
Interventional armActive comparatorPatients 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.
Receives: Behavioral: Physical exercises
controled armPlacebo comparatorPatients 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.
Receives: Behavioral: Physical exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: After 4 weeks

  2. 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

    Measured: After 4 weeks

  3. Clinical response as assessed by a change in PROMIS questionnaire

    PROMIS (Patient-Reported Outcomes Measurement Information System)

    Measured: After 4 weeks

  4. Clinical response as assessed by a change in QOL questionnaire

    Quality of life questionnaire

    Measured: After 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2020
  2. Study start8 Jul 2019
  3. Primary completion1 Aug 2024
  4. Study completion1 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04303260
Sponsor's protocol ID
0277-18-TLV
Status last verified
Feb 2025
First submitted
1 Jul 2019
Last updated
14 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercises in people with Crohn Disease and Ulcerative Colitis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical response assessed by a change in HBI (time frame: After 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04303260.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.

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