Abdominally Targeted Management Exercises for Crohn's Disease Patients (TAME-CD)

NCT06917443 | Not Yet Recruiting

• 2 other identifiers: 0438-24-TLVMOH_2024-11-20_013744
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if abdominally targeted exercises can assist to manage disease activity in Crohn disease (CD) patients. The main questions it aims to answer are: Does abdominally targeted exercises can improve the quality of life of CD patients. Does abdominally targeted exercises positively influence clinical and biological responses in CD patients. Researchers will compare performing sets of special physical exercises designed for CD patients, compared to a control set of exercises ("generic" physical activity) to see if exercises designed for CD can result in an improved quality of life, in CD patients suffering from mild to moderate disease activity. Participants will:

• Perform physical exercises designed for CD or control set of exercises every day for 8 weeks.
• Visit the clinic once every 4 weeks for doctor visit, blood and stool test and filling out questionnaires.

Conditions

Crohn Disease (CD); IBD (Inflammatory Bowel Disease)

Keywords

physical exercise; Crohn's disease; randomized trial

Outcome Measures

Primary Outcomes (6)

• Clinical response rate

  Clinical response rate will be assessed by using a clinical activity index, Harvey-Bradshaw index (HBI), and defined by a decrease of ≥3 points. A greater decrease is regarded as a better response.

  From enrollment to the end of treatment at 8 weeks

• Clinical remission rate

  Clinical remission rate will be assessed by using a clinical activity index, HBI defined by achieving HBI\<5. Lower scores indicate lower disease activity and severity.

  From enrollment to the end of treatment at 8 weeks

• Biomarker remission rate

  biomarker remission as defined by calprotectin \<150 μg/g. Lower levels indicate better outcome

  From enrollment to the end of treatment at 8 weeks

• Biomarker remission rate

  Biomarker remission as defined by CRP levels \<5 mg/L. Lower levels indicate better outcome

  From enrollment to the end of treatment at 8 weeks

• Change from Baseline in mean values of PROMIS-29 scores

  To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS-29)

  From enrollment to the end of treatment at 8 weeks

• Change from Baseline in mean values of IBDQ

  To assess the differences in patients' perceived QoL according to patients reported outcomes questionnaires: Inflammatory Bowel Disease Questionnaire (IBDQ)

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (6)

• Biomarker response rate

  From enrollment to the end of treatment at 8 weeks

• IUS remission rate

  End of treatment at 8 weeks

• Clinical remission rate

  From enrollment to 4 weeks

• Clinical response rate

  From enrollment to 4 weeks

• Change from Baseline in mean values of PROMIS-29 scores

  From enrollment to 4 weeks

Other Outcomes (3)

• Change from baseline in mean serum levels of LBP

  From enrollment to the end of treatment at 8 weeks

• Change from baseline in mean serum levels of LBP

  From enrollment to 4 weeks

• Treatment affect on microbiome and metabolome composition or function

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Abdominally targeted exercises

EXPERIMENTAL

The interventional exercise regimen will include specific abdominally targeted exercises postulated to increase blood flow to the intestine and decrease inflammation. Patients will be asked to perform the exercises 6 days every week. Patients will be asked to complete 3 different videos repeatedly, one video per day, as many days a week as possible.

Other: Abdominally targeted exercises

Generally recommended exercises

PLACEBO COMPARATOR

The control arm will practice generally recommended exercises, without particular attention to the abdomen. Patients will be asked to perform the exercises 6 days every week. Patients will be asked to complete 3 different videos repeatedly, one video per day, as many days a week as possible.

Other: General exercises

Interventions

Abdominally targeted exercises OTHER

The interventional exercise regimen will include specific abdominally targeted exercises postulated to increase blood flow to the intestine and decrease inflammation.

Abdominally targeted exercises

General exercises OTHER

Generally recommended exercises, without particular attention to the abdomen

Generally recommended exercises

Eligibility Criteria

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

You may qualify if:

• Patients with no treatment or on constant medicinal therapy, expected to remain constant: mesalamine for at least 6 weeks, steroids at least 2 weeks (≤20mg prednisone or budesonide ≤6mg), immunomodulatory at least 12 weeks or biologics/ small molecules for at least 12 weeks therapy. Patients who initiate the study on steroids will remain on a constant dose throughout the study.
• If patients stopped therapy prior to the study then they should be at least 2 weeks from stopping steroids or 5ASA, or 4 weeks from stopping small molecules, 8 weeks from stopping biologics, or 12 weeks from stopping thiopurines.
• CD patients will be included if their symptoms score \>4 and ≤15 on the HBI score
• Fecal calprotectin\>150ug/gr or evidence of an active disease per IUS defined as increased blood flow (modified Limberg score\>0) or thickness of bowel wall\>3mm

You may not qualify if:

• Inability to commit for performing at least 10-15 minutes of exercise, 6 times a week.
• Lack of availability or capability to use a computer/ internet.
• Any proven current infection such as, fever, active abscess, Clostridioides difficile infection, positive stool culture, or parasite in patients with chronic diarrhea.
• Inability to sign informed consent and/ or complete the study protocol.
• Incompetent individuals who are unable to provide informed consent.
• Planed pregnancy or pregnancy- up to 3 months post labor.
• Subjects with chronic conditions such as active arthritis, cancer (within the previous 5 years, not including BCC, SCC), organ transplant subjects, advanced kidney or liver disease, or systemic inflammatory conditions other than IBD.
• Patients who underwent surgery in the previous 3 months, had more than 1 surgery of intestinal resection, patients with ileostomy, pouch or patients with short bowel (small intestine\<1.5 meter).
• Patients with a significant abdominal wall hernia, unless received a written confirmation from a treating surgeon.
• Active peri-anal disease (fistula, abscess, fissure), stricturing or penetrating disease
• Active extra-intestinal manifestations (not excluded are- oral aphthae and peripheral arthralgia without arthritis)
• Patients on total parenteral nutrition (TPN) or on exclusive enteral nutrition (EEN).
• Probiotics or antibiotics in the 15 days prior to enrollment or during the study period.

Sponsors & Collaborators

• Shmuel Kivity, MD: lead

Study Sites (1)

Department of Gastroenterology and Liver Diseases, Tel Aviv Medical Center

Tel Aviv, Israel, Israel

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Behavior

Study Officials

• Nitsan Maharshak, Professor

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitsan Maharshak, Professor

CONTACT

+972527360384; nitsanm@tlvmc.gov.il

Rony Izhar, PhD

CONTACT

+972504991116; ronyi@tlvmc.gov.il

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: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized to either intervention or control arm in 2:1 ratio, respectively.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: April 8, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: April 8, 2025

Record last verified: 2025-03

Locations

IL (1)