Inflammatory Bowel DiseasesNCT05455762
The Efficacy of Exercise Therapy in Patients With Inflammatory Bowel Disease
A study testing Exercise in people with Inflammatory Bowel Diseases and Sarcopenia, run by Tehran University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Sarcopenia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIran
- Study dates
- Jul 2022to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)
- Conditions
- Inflammatory Bowel Diseases, Sarcopenia
- Being tested
- Exercise
- Keywords
- inflammatory bowel disease, aerobic exercise, resistance exercise, sarcopenia, quality of life
- Medical subject headings
- Inflammatory Bowel Diseases, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
assessed by IBDQ-9 questionnaire
Measured: Baseline
Health-related quality of life
assessed by IBDQ-9 questionnaire
Measured: day 56
Secondary outcomes (22)
6 minute walk test
distance walked in 6 minute with max speed
Measured: Baseline
6 minute walk test
distance walked in 6 minute with max speed
Measured: day 56
Knee extensor muscle strength
muscle force measured by manual dynamometer
Measured: Baseline
Knee extensor muscle strength
Knee extensor muscle strength
Measured: Day 56
Elbow flexor muscle strength
muscle force measured by manual dynamometer
Measured: Baseline
Elbow flexor muscle strength
muscle force measured by manual dynamometer
Measured: Day 56
Hip flexor muscle strength
Muscle force measured by manual dynamometer
Measured: Baseline
Hip flexor muscle strength
Muscle force measured by manual dynamometer
Measured: Day 56
shoulder abductor muscle strength
Muscle force measured by manual dynamometer
Measured: Baseline
shoulder abductor muscle strength
Muscle force measured by manual dynamometer
Measured: Day 56
hand grip strength
Muscle force measured by manual dynamometer
Measured: Baseline
hand grip strength
Muscle force measured by manual dynamometer
Measured: Day 56
partial mayo score
calculated based on patient answers
Measured: Baseline
partial mayo score
calculated based on patient answers
Measured: Day 56
Harvey Bradshaw index
calculated based on patient answers
Measured: Baseline
Harvey Bradshaw index
calculated based on patient answers
Measured: Day 56
erythrocyte sedimentation rate
Measured using laboratory techniques
Measured: Baseline
erythrocyte sedimentation rate
Measured using laboratory techniques
Measured: Day 56
C-reactive protein
Measured using laboratory techniques
Measured: Baseline
C-reactive protein
Measured using laboratory techniques
Measured: Day 56
Stool calprotectin
Measured using laboratory techniques
Measured: Baseline
Stool calprotectin
Measured using laboratory techniques
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Javaherian, Tehran University of Medical Sciences
- Investigators
- Foroogh Alborzi, M.D., Study chair, Tehran University of Medical Sciences, Imam Khomeini hospital complexSaeed Mirmoosavi, M.D. Student, Principal investigator, Tehran University of Medical SciencesMohammad Javaherian, Ph.D., Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455762
- Sponsor's protocol ID
- 9511215137
- Status last verified
- Jul 2022
- First submitted
- 10 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05455762
- Acronym / sponsor ID
- 9511215137
- Conditions
- Inflammatory Bowel Diseases, Sarcopenia
- Keywords
- inflammatory bowel disease, aerobic exercise, resistance exercise, sarcopenia, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercisepatients 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. |
| Control group | No intervention | –The patients in this group will continue their routine life and treatment prescribed by the gastroenterologist for their condition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients with PSC
- Patients with cirrhosis
- Patients with colon cancer
- Patients on corticosteroid treatment
- Patients' dissatisfaction to continue the study for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Other | Exercise group |
Primary outcome
Health-related quality of life
Time frame: Baseline
assessed by IBDQ-9 questionnaire
Health-related quality of life
Time frame: day 56
assessed by IBDQ-9 questionnaire
22 secondary outcomes
6 minute walk test
Time frame: Baseline
6 minute walk test
Time frame: day 56
Knee extensor muscle strength
Time frame: Baseline
Knee extensor muscle strength
Time frame: Day 56
Elbow flexor muscle strength
Time frame: Baseline
Elbow flexor muscle strength
Time frame: Day 56
Hip flexor muscle strength
Time frame: Baseline
Hip flexor muscle strength
Time frame: Day 56
shoulder abductor muscle strength
Time frame: Baseline
shoulder abductor muscle strength
Time frame: Day 56
hand grip strength
Time frame: Baseline
hand grip strength
Time frame: Day 56
partial mayo score
Time frame: Baseline
partial mayo score
Time frame: Day 56
Harvey Bradshaw index
Time frame: Baseline
Harvey Bradshaw index
Time frame: Day 56
erythrocyte sedimentation rate
Time frame: Baseline
erythrocyte sedimentation rate
Time frame: Day 56
C-reactive protein
Time frame: Baseline
C-reactive protein
Time frame: Day 56
Stool calprotectin
Time frame: Baseline
Stool calprotectin
Time frame: Day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Foroogh Alborzi, M.D. study chair
Tehran University of Medical Sciences, Imam Khomeini hospital complex
Saeed Mirmoosavi, M.D. Student principal investigator
Tehran University of Medical Sciences
Mohammad Javaherian, Ph.D. principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Inflammatory Bowel Diseases and Sarcopenia, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Javaherian, Ph.D. (+989129321391, Javaherian_m@razi.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.