Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05455762
Enrollment
56
Registered
2022-07-13
Start date
2022-07-31
Completion date
2022-11-30
Last updated
2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Sarcopenia

Keywords

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

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)

Interventions

OTHERExercise

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.

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Health-related quality of lifeBaselineassessed by IBDQ-9 questionnaire

Secondary

MeasureTime frameDescription
Hip flexor muscle strengthBaselineMuscle force measured by manual dynamometer
shoulder abductor muscle strengthBaselineMuscle force measured by manual dynamometer
hand grip strengthBaselineMuscle force measured by manual dynamometer
partial mayo scoreBaselinecalculated based on patient answers
Harvey Bradshaw indexBaselinecalculated based on patient answers
Elbow flexor muscle strengthBaselinemuscle force measured by manual dynamometer
C-reactive proteinBaselineMeasured using laboratory techniques
Stool calprotectinBaselineMeasured using laboratory techniques
6 minute walk testBaselinedistance walked in 6 minute with max speed
Knee extensor muscle strengthBaselinemuscle force measured by manual dynamometer
erythrocyte sedimentation rateBaselineMeasured using laboratory techniques

Countries

Iran

Contacts

Primary ContactMohammad Javaherian, Ph.D.
Javaherian_m@razi.tums.ac.ir+989129321391

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026