Health Condition 1: K51- Ulcerative colitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 to 70 years Established diagnosis of Ulcerative colitis with standard criteria (Colonoscopy + histology, Ancillary investigations (ESR, CRP, Faecal calprotectin). Inactive ulcerative colitis Patients should be in remission at least 4 weeks prior to enrolment and on standard of care treatment Presence of sarcopenia at screening defined by South Asian working action group- Sarcopenia (SWAG- SARCO) criteria
Exclusion criteria
Exclusion criteria: 1.Active disease at enrollment 2. Clinical relapse or requirement for induction therapy or steroids within prior 4 weeks 3. Patients on biologicals 4. Chronic diseases that may affect muscle mass such as CLD, CHF, CKD, patients with rheumatic diseases 5. Intestinal obstruction 6. Toxic megacolon 7. Malignancy 8. Pregnancy 9. Neurological diseases like CVA, Parkinson s disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate clinical relapse rates among adult patients of Ulcerative Colitis with sarcopenia randomized to high-protein diet plus structured resistance training programme versus standard of care.Timepoint: 3,6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate change in muscle mass as determined by BIA, muscle strength as determined by handgrip & physical function as determined by gait speed between the two groups Timepoint: 3, 6 & 12 months;To assess the change in quality of life between the two groups using SF 36 questionnaire Timepoint: baseline & 12 months;To determine the need for biologicals/colectomy in both groupTimepoint: 3, 6 & 12 months. | — |
Countries
India
Contacts
ABVIMS and Dr RML hospital