The Efficacy of Exercise Therapy in Patients With Inflammatory Bowel Disease

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05455762
• Other study ID #: 9511215137
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: November 2022

Study information

• Verified date: July 2022
• Source: Tehran University of Medical Sciences
• Contact: Mohammad Javaherian, Ph.D.
• Phone: +989129321391
• Email: Javaherian_m[@]razi.tums.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomeini Hospital Complex	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life	assessed by IBDQ-9 questionnaire	Baseline
Primary	Health-related quality of life	assessed by IBDQ-9 questionnaire	day 56
Secondary	6 minute walk test	distance walked in 6 minute with max speed	Baseline
Secondary	6 minute walk test	distance walked in 6 minute with max speed	day 56
Secondary	Knee extensor muscle strength	muscle force measured by manual dynamometer	Baseline
Secondary	Knee extensor muscle strength	Knee extensor muscle strength	Day 56
Secondary	Elbow flexor muscle strength	muscle force measured by manual dynamometer	Baseline
Secondary	Elbow flexor muscle strength	muscle force measured by manual dynamometer	Day 56
Secondary	Hip flexor muscle strength	Muscle force measured by manual dynamometer	Baseline
Secondary	Hip flexor muscle strength	Muscle force measured by manual dynamometer	Day 56
Secondary	shoulder abductor muscle strength	Muscle force measured by manual dynamometer	Baseline
Secondary	shoulder abductor muscle strength	Muscle force measured by manual dynamometer	Day 56
Secondary	hand grip strength	Muscle force measured by manual dynamometer	Baseline
Secondary	hand grip strength	Muscle force measured by manual dynamometer	Day 56
Secondary	partial mayo score	calculated based on patient answers	Baseline
Secondary	partial mayo score	calculated based on patient answers	Day 56
Secondary	Harvey Bradshaw index	calculated based on patient answers	Baseline
Secondary	Harvey Bradshaw index	calculated based on patient answers	Day 56
Secondary	erythrocyte sedimentation rate	Measured using laboratory techniques	Baseline
Secondary	erythrocyte sedimentation rate	Measured using laboratory techniques	Day 56
Secondary	C-reactive protein	Measured using laboratory techniques	Baseline
Secondary	C-reactive protein	Measured using laboratory techniques	Day 56
Secondary	Stool calprotectin	Measured using laboratory techniques	Baseline
Secondary	Stool calprotectin	Measured using laboratory techniques	Day 56