Prevalence of muscle weakness in IBD and effect of treatment on muscle weakness
- Conditions
- Health Condition 1: K509- Crohns disease, unspecifiedHealth Condition 2: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2024/01/061649
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria (First phase)
1)Age between 18 years to 65 years
2)Patients with aggressive IBD as defined above
3)Provide informed consent
Inclusion Criteria (Second phase)
1)Patients found to be having sarcopenia during first phase of the study randomized into intervention arm and standard treatment arm
2)Provide informed consent
Exclusion Criteria (First phase)
1)Patients with other comorbid illnesses (end stage liver, kidney, cardiac illnesses, neuromuscular illnesses and terminal cancer patients)
2)Pregnancy and Lactation
Exclusion Criteria (Second phase)
1)Patients with other comorbid illnesses (end stage liver, kidney, cardiac illnesses, neuromuscular illnesses and terminal cancer patients)
2)Pregnancy and lactation
3)Inability to perform exercise
4)Inability to adhere to prescribed diet / nutritional supplements
5)Patients requiring surgery
6)Patients enrolled in other trials
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Prevalence of sarcopenia in IBD / CD / UC patients <br/ ><br>2.Improvement in HGS after 24 weeks of intervention (HP AID & resistance plus endurance exercises) <br/ ><br>Timepoint: 0 and 24 weeks
- Secondary Outcome Measures
Name Time Method 1.Impact of HP AID and resistance + endurance exercises on sarcopenia as well as on clinical outcomes <br/ ><br>2.Prevalence of frailty in IBD patients <br/ ><br>3.Predictors of sarcopenia and frailty <br/ ><br>4.Impact of sarcopenia and frailty on various clinical outcomes <br/ ><br>5.Sn, Sp, PPV, NPV and accuracy of various measures of sarcopenia <br/ ><br>Timepoint: 0 and 24 weeks