The Efficacy of Exercise Therapy in Patients With Inflammatory Bowel Disease

Study Overview
=================
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)

Official Title
-----------------
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

Conditions
-----------------
Inflammatory Bowel Diseases, Sarcopenia

Intervention / Treatment
-----------------
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br>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. | Other: Exercise<br>* 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.<br>|
| No Intervention: Control group<br>The patients in this group will continue their routine life and treatment prescribed by the gastroenterologist for their condition | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | assessed by IBDQ-9 questionnaire | Baseline | 
| Health-related quality of life | assessed by IBDQ-9 questionnaire | day 56 | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammatory bowel disease, aerobic exercise, resistance exercise, sarcopenia, quality of life