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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Bowel Diseases; Sarcopenia
• Intervention / Treatment: Other: Exercise

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: Interventional
• Enrollment (Anticipated): 56
• 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

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Imam khomeini hospital complex
    • Contact: Forough Alborzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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.	Other: Exercise; 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.
No Intervention: Control group; 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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• 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): July 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: July 10, 2022
• First Submitted That Met QC Criteria: July 10, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 10, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; aerobic exercise; resistance exercise; sarcopenia; inflammatory bowel disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Gastroenteritis; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Inflammatory Bowel Diseases; Sarcopenia; Intestinal Diseases
• Other Study ID Numbers: 9511215137

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No