The Efficacy of Exercise Therapy in Patients With Inflammatory Bowel Disease

Not Applicable

• Conditions: Sarcopenia; Inflammatory Bowel Diseases
• Interventions: Other: Exercise

• Registration Number: NCT05455762
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

this study aims to determine the effect of 8 weeks of exercise on the quality of life and muscle strength of patients with IBD. Patients will be randomized into 1) Intervention group: doing aerobic and resistance exercise according to physiotherapist prescription and 2) Control group: usual medical care. Both groups will continue their medications prescribed by the Gastroenterologist. After 8 weeks patients come back to the hospital for reevaluation of measured indices. The primary outcome of this study is the patient quality of life assessed by the IBDQ questionnaire. Other outcomes that will be evaluated before and after 8 weeks are muscle strength measured by a dynamometer and laboratory markers such as ESR and CRP and tool calprotectin. Also, disease activity using partial mayo score and Harvey Bradshaw score will be calculated and compared before and after 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 Timeline

• Status Verified: 2022-07
• Study Start: 2022-07
• Study First Submitted: 2022-07-10
• Study First Submitted QC: 2022-07-10
• Last Update Submitted: 2022-07-10
• Study First Posted: 2022-07-13
• Last Update Posted: 2022-07-13
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Patients with IBD (UC or Chron's) confirmed by colonoscopy and pathology
2. Be able to read and write in Farsi
3. Be able to participate to exercise therapy program.

Exclusion Criteria

1. Patients with PSC
2. Patients with cirrhosis
3. Patients with colon cancer
4. Patients on corticosteroid treatment
5. Patients' dissatisfaction to continue the study for any reason
6. Patients who exercise on a daily routine (more than 30 minutes per day)
7. Patients having any contraindication for exercise training.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Exercise	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.

Primary Outcome Measures

Name	Time	Method
Health-related quality of life	day 56	assessed by IBDQ-9 questionnaire

Secondary Outcome Measures

Name	Time	Method
Stool calprotectin	Day 56	Measured using laboratory techniques
6 minute walk test	day 56	distance walked in 6 minute with max speed
hand grip strength	Day 56	Muscle force measured by manual dynamometer
C-reactive protein	Day 56	Measured using laboratory techniques
Knee extensor muscle strength	Day 56	Knee extensor muscle strength
Hip flexor muscle strength	Day 56	Muscle force measured by manual dynamometer
partial mayo score	Day 56	calculated based on patient answers
Harvey Bradshaw index	Day 56	calculated based on patient answers
erythrocyte sedimentation rate	Day 56	Measured using laboratory techniques
Elbow flexor muscle strength	Day 56	muscle force measured by manual dynamometer
shoulder abductor muscle strength	Day 56	Muscle force measured by manual dynamometer

Trial Locations

Locations (1)

Imam Khomeini Hospital Complex; 🇮🇷 Tehran, Iran, Islamic Republic of