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The Efficacy of Exercise Therapy in Patients With Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Diseases, Sarcopenia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Exercise
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring inflammatory bowel disease, aerobic exercise, resistance exercise, sarcopenia, quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imam Khomeini Hospital Complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Health-related quality of life
assessed by IBDQ-9 questionnaire
Health-related quality of life
assessed by IBDQ-9 questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
July 10, 2022
Last Updated
July 10, 2022
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05455762
Brief Title
The Efficacy of Exercise Therapy in Patients With Inflammatory Bowel Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Sarcopenia
Keywords
inflammatory bowel disease, aerobic exercise, resistance exercise, sarcopenia, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients in this group will continue their routine life and treatment prescribed by the gastroenterologist for their condition
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health-related quality of life
Description
assessed by IBDQ-9 questionnaire
Time Frame
Baseline
Title
Health-related quality of life
Description
assessed by IBDQ-9 questionnaire
Time Frame
day 56
Secondary Outcome Measure Information:
Title
6 minute walk test
Description
distance walked in 6 minute with max speed
Time Frame
Baseline
Title
6 minute walk test
Description
distance walked in 6 minute with max speed
Time Frame
day 56
Title
Knee extensor muscle strength
Description
muscle force measured by manual dynamometer
Time Frame
Baseline
Title
Knee extensor muscle strength
Description
Knee extensor muscle strength
Time Frame
Day 56
Title
Elbow flexor muscle strength
Description
muscle force measured by manual dynamometer
Time Frame
Baseline
Title
Elbow flexor muscle strength
Description
muscle force measured by manual dynamometer
Time Frame
Day 56
Title
Hip flexor muscle strength
Description
Muscle force measured by manual dynamometer
Time Frame
Baseline
Title
Hip flexor muscle strength
Description
Muscle force measured by manual dynamometer
Time Frame
Day 56
Title
shoulder abductor muscle strength
Description
Muscle force measured by manual dynamometer
Time Frame
Baseline
Title
shoulder abductor muscle strength
Description
Muscle force measured by manual dynamometer
Time Frame
Day 56
Title
hand grip strength
Description
Muscle force measured by manual dynamometer
Time Frame
Baseline
Title
hand grip strength
Description
Muscle force measured by manual dynamometer
Time Frame
Day 56
Title
partial mayo score
Description
calculated based on patient answers
Time Frame
Baseline
Title
partial mayo score
Description
calculated based on patient answers
Time Frame
Day 56
Title
Harvey Bradshaw index
Description
calculated based on patient answers
Time Frame
Baseline
Title
Harvey Bradshaw index
Description
calculated based on patient answers
Time Frame
Day 56
Title
erythrocyte sedimentation rate
Description
Measured using laboratory techniques
Time Frame
Baseline
Title
erythrocyte sedimentation rate
Description
Measured using laboratory techniques
Time Frame
Day 56
Title
C-reactive protein
Description
Measured using laboratory techniques
Time Frame
Baseline
Title
C-reactive protein
Description
Measured using laboratory techniques
Time Frame
Day 56
Title
Stool calprotectin
Description
Measured using laboratory techniques
Time Frame
Baseline
Title
Stool calprotectin
Description
Measured using laboratory techniques
Time Frame
Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Javaherian, Ph.D.
Phone
+989129321391
Email
Javaherian_m@razi.tums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Foroogh Alborzi, M.D.
Organizational Affiliation
Tehran University of Medical Sciences, Imam Khomeini hospital complex
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Saeed Mirmoosavi, M.D. Student
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Javaherian, Ph.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imam Khomeini Hospital Complex
City
Tehran
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Forough Alborzi

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of Exercise Therapy in Patients With Inflammatory Bowel Disease

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