- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05455762
The Efficacy of Exercise Therapy in Patients With Inflammatory Bowel Disease
Evaluating the Efficacy of Eight-week Combined Aerobic and Resistance Exercise on Clinical and Laboratory Findings and Quality of Life in Patients With Inflammatory Bowel Disease: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inflammatory bowel disease has a huge burden both on patients and on the health system due to its chronic nature. Studies have shown a higher prevalence of sarcopenia, a condition in which muscle mass and strength decreases, in patients with IBD compared to age and sex-matched healthy individuals. Patients with IBD are physically less active than the normal population according to a couple of researches. There has been a growing interest to evaluate the effect of exercise on the quality of life and disease severity of IBD patients in recent years.
This study aims to determine the effectiveness of combined aerobic and resistance exercise on quality of life, physical function, muscle strength, disease activity, and laboratory markers in patients with established IBD.
The researchers will invite 56 patients to the Imam Khomeini hospital complex, Tehran, Iran. All patients will be enrolled after taking informed consent. Interventions will be conducted with the coordination of the patient's physician. Patients will be randomized to the intervention or control group. Outcome measurements will be evaluated immediately before and after the interventions (8 weeks period)
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammad Javaherian, Ph.D.
- Phone Number: +989129321391
- Email: Javaherian_m@razi.tums.ac.ir
Study Locations
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Tehran, Iran, Islamic Republic of
- Imam Khomeini Hospital Complex
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Contact:
- Forough Alborzi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with IBD (UC or Chron's) confirmed by colonoscopy and pathology
- Be able to read and write in Farsi
- Be able to participate to exercise therapy program.
Exclusion Criteria:
- Patients with PSC
- Patients with cirrhosis
- Patients with colon cancer
- Patients on corticosteroid treatment
- Patients' dissatisfaction to continue the study for any reason
- Patients who exercise on a daily routine (more than 30 minutes per day)
- Patients having any contraindication for exercise training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise group
patients in this group will participate in an 8 week program of exercise.
The exercise program includes both aerobic and resistance exercise.
The patients will exercise 6 days a week,3 days aerobic exercise and 3 days resistance ones.
The aerobic exercise consists of 20 minutes walking.
Patients will walk slowly in the first five minutes to warm up, then they walk faster and with the intensity prescribed by the physiotherapist.
In the last 5 minutes the patient will walk like the first 5 minutes.
The middle 10 minutes may be increased or not based on patients' weekly self-report.
The resistance training include hip abduction, shoulder abduction, bridging, elbow flexion and knee extension.
each of these exercises is done in 3 set of 10 repetition with one minute break between each set.
Based on patients' weekly report a 0.5 kilogram weight might be added.
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The intervention consists of 8 week of combined resistance and aerobic exercise.
Patients will exercise 6 days a week;3 days aerobic ones and 3 days resistance ones.
The aerobic exercise include 20 minutes of walking divided into three parts.
In the first five minute the patients walks slowly to warm up, in the next 10 minutes the patient will speedup to reach the intensity described by the physiotherapist.
In the last 5 minutes the patient walks like the first five minutes.
The middle 10 minutes may be increased or not based on patient's weekly report.
The resistance training consists of 5 exercise; hip abduction, shoulder abduction, bridging, elbow flexion and knee extension.
each of these exercises is done in 3 set of 10 repetition with one minute break between each set.
Based on patients' weekly report a 0.5 kilogram weight might be added.
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No Intervention: Control group
The patients in this group will continue their routine life and treatment prescribed by the gastroenterologist for their condition
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health-related quality of life
Time Frame: Baseline
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assessed by IBDQ-9 questionnaire
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Baseline
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Health-related quality of life
Time Frame: day 56
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assessed by IBDQ-9 questionnaire
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day 56
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 minute walk test
Time Frame: Baseline
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distance walked in 6 minute with max speed
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Baseline
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6 minute walk test
Time Frame: day 56
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distance walked in 6 minute with max speed
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day 56
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Knee extensor muscle strength
Time Frame: Baseline
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muscle force measured by manual dynamometer
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Baseline
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Knee extensor muscle strength
Time Frame: Day 56
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Knee extensor muscle strength
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Day 56
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Elbow flexor muscle strength
Time Frame: Baseline
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muscle force measured by manual dynamometer
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Baseline
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Elbow flexor muscle strength
Time Frame: Day 56
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muscle force measured by manual dynamometer
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Day 56
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Hip flexor muscle strength
Time Frame: Baseline
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Muscle force measured by manual dynamometer
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Baseline
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Hip flexor muscle strength
Time Frame: Day 56
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Muscle force measured by manual dynamometer
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Day 56
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shoulder abductor muscle strength
Time Frame: Baseline
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Muscle force measured by manual dynamometer
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Baseline
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shoulder abductor muscle strength
Time Frame: Day 56
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Muscle force measured by manual dynamometer
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Day 56
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hand grip strength
Time Frame: Baseline
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Muscle force measured by manual dynamometer
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Baseline
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hand grip strength
Time Frame: Day 56
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Muscle force measured by manual dynamometer
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Day 56
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partial mayo score
Time Frame: Baseline
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calculated based on patient answers
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Baseline
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partial mayo score
Time Frame: Day 56
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calculated based on patient answers
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Day 56
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Harvey Bradshaw index
Time Frame: Baseline
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calculated based on patient answers
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Baseline
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Harvey Bradshaw index
Time Frame: Day 56
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calculated based on patient answers
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Day 56
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erythrocyte sedimentation rate
Time Frame: Baseline
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Measured using laboratory techniques
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Baseline
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erythrocyte sedimentation rate
Time Frame: Day 56
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Measured using laboratory techniques
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Day 56
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C-reactive protein
Time Frame: Baseline
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Measured using laboratory techniques
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Baseline
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C-reactive protein
Time Frame: Day 56
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Measured using laboratory techniques
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Day 56
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Stool calprotectin
Time Frame: Baseline
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Measured using laboratory techniques
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Baseline
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Stool calprotectin
Time Frame: Day 56
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Measured using laboratory techniques
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Day 56
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Collaborators and Investigators
Investigators
- Study Chair: Foroogh Alborzi, M.D., Tehran University of Medical Sciences, Imam Khomeini hospital complex
- Principal Investigator: Saeed Mirmoosavi, M.D. Student, Tehran University of Medical Sciences
- Principal Investigator: Mohammad Javaherian, Ph.D., Tehran University of Medical Sciences
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9511215137
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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