The Efficacy of Exercise Therapy in Patients With Inflammatory Bowel Disease

NCT05455762 | Unknown

• 1 other identifier: 9511215137
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Sarcopenia

Keywords

inflammatory bowel disease; aerobic exercise; resistance exercise; sarcopenia; quality of life

Outcome Measures

Primary Outcomes (2)

• Health-related quality of life

  assessed by IBDQ-9 questionnaire

  Baseline

• Health-related quality of life

  assessed by IBDQ-9 questionnaire

  day 56

Secondary Outcomes (22)

• 6 minute walk test

  Baseline

• 6 minute walk test

  day 56

• Knee extensor muscle strength

  Baseline

• Knee extensor muscle strength

  Day 56

• Elbow flexor muscle strength

  Baseline

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The patients in this group will continue their routine life and treatment prescribed by the gastroenterologist for their condition

Interventions

Exercise OTHER

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.

Exercise group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Imam Khomeini Hospital Complex

Tehran, Iran

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Sarcopenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Foroogh Alborzi, M.D.

  Tehran University of Medical Sciences, Imam Khomeini hospital complex

  STUDY CHAIR

• Saeed Mirmoosavi, M.D. Student

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mohammad Javaherian, Ph.D.

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Javaherian, Ph.D.

CONTACT

+989129321391; Javaherian_m@razi.tums.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mohammad Javaherian

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: July 13, 2022
• Study Start: July 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

IR (1)