Clinical trial NCT05455762: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Sarcopenia
Keywords: inflammatory bowel disease
aerobic exercise
resistance exercise
sarcopenia
quality of life
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: day 56
Secondary outcomes:
measure: 6 minute walk test
timeFrame: Baseline
measure: 6 minute walk test
timeFrame: day 56
measure: Knee extensor muscle strength
timeFrame: Baseline
measure: Knee extensor muscle strength
timeFrame: Day 56
measure: Elbow flexor muscle strength
timeFrame: Baseline
measure: Elbow flexor muscle strength
timeFrame: Day 56
measure: Hip flexor muscle strength
timeFrame: Baseline
measure: Hip flexor muscle strength
timeFrame: Day 56
measure: shoulder abductor muscle strength
timeFrame: Baseline
measure: shoulder abductor muscle strength
timeFrame: Day 56
measure: hand grip strength
timeFrame: Baseline
measure: hand grip strength
timeFrame: Day 56
measure: partial mayo score
timeFrame: Baseline
measure: partial mayo score
timeFrame: Day 56
measure: Harvey Bradshaw index
timeFrame: Baseline
measure: Harvey Bradshaw index
timeFrame: Day 56
measure: erythrocyte sedimentation rate
timeFrame: Baseline
measure: erythrocyte sedimentation rate
timeFrame: Day 56
measure: C-reactive protein
timeFrame: Baseline
measure: C-reactive protein
timeFrame: Day 56
measure: Stool calprotectin
timeFrame: Baseline
measure: Stool calprotectin
timeFrame: Day 56
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini Hospital Complex
Study officials:
affiliation: Tehran University of Medical Sciences, Imam Khomeini hospital complex
name: Foroogh Alborzi, M.D.
role: STUDY_CHAIR
affiliation: Tehran University of Medical Sciences
name: Saeed Mirmoosavi, M.D. Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Tehran University of Medical Sciences
name: Mohammad Javaherian, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: