| CTRI Number |
CTRI/2026/03/106585 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Diet and Resistance Training in Preventing Relapse in Ulcerative Colitis with Sarcopenia |
|
Scientific Title of Study
|
Effect of dietary intervention and resistance training on relapse rate among adult patients of Ulcerative colitis with sarcopenia : A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anmol Saini |
| Designation |
Senior resident |
| Affiliation |
ABVIMS and Dr RML hospital |
| Address |
ABVIMS and Dr RML Hospital
Baba Kharak Singh Rd, near Gurudwara Bangla Sahib, Ram Manohar Lohia Hospital, Type III, Connaught Place, New Delhi, Delhi 110001
Central
DELHI
110001
India |
| Phone |
9958964544 |
| Fax |
|
| Email |
saini.anmol94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Rajpoot |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML hospital |
| Address |
ABVIMS and Dr RML Hospital
Baba Kharak Singh Rd, near Gurudwara Bangla Sahib, Ram Manohar Lohia Hospital, Type III, Connaught Place, New Delhi, Delhi 110001
Central
DELHI
110001
India |
| Phone |
7570096707 |
| Fax |
|
| Email |
prajpoot15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anmol Saini |
| Designation |
Senior resident |
| Affiliation |
ABVIMS and Dr RML hospital |
| Address |
ABVIMS and Dr RML Hospital
Baba Kharak Singh Rd, near Gurudwara Bangla Sahib, Ram Manohar Lohia Hospital, Type III, Connaught Place, New Delhi, Delhi 110001
DELHI
110001
India |
| Phone |
9958964544 |
| Fax |
|
| Email |
saini.anmol94@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Abvims and Dr Rml hospital |
| Address |
Baba Kharak Singh Road near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital, Type III Connaught Place New Delhi Delhi 110001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anmol saini |
Nursing home room number 10, ABVIMS and Dr RML hospital, New Delhi |
Baba Kharak Singh Rd, near Gurudwara Bangla Sahib, Ram Manohar Lohia Hospital, Type III, Connaught Place, New Delhi, Delhi 110001
Central
DELHI |
01123404040
diary.section@rmlh.nic.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,ABVIMS,DR RML Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K51||Ulcerative colitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High protein diet and resistance training |
DietaryPlan:
Individualized by a clinical dietitian based on total energy requirement (25–35 kcal/kg/day). High-
quality protein sources (whey, dairy, soy, fish, eggs) will be emphasized according to the
vegetarian/non-vegetarian status of the patient.
Adherence will be monitored telephonically weekly and monthly by the dietitian.
Exercise Plan
Progressive resistance training- Structured Individualized rehabilitation program for 40 minutes
including warm up and cool down period comprising of :
- Warm-Up (5 minutes)
- Upper Limb Strengthening exercises (20 minutes) : targeting shoulders stabiliser, arms &
forearm flexor & extensors & intrinsic muscle of hands, back extensor
- Lower Limb Strengthening (12 minutes): targeting gastrosoleus, quadriceps , gluteal muscle
and coregroup
- Cool-Down and Stretch (3 minutes)
- Frequency: 3 sessions/week on alternating days. Two sets of 10-12 repetition
- Intensity: Start at 40–60% of 1RM or 3–5 RPE, progress as tolerated.
- Progression cues: Increase resistance when completing all repetition easily without fatigue.
- 30 minutes walking on alternate days
Supervised sessions will be conducted weekly initially and then 4 weekly for 12 months under the
supervision of Department of PMR. Adherence will be monitored by asking patients to send their
videos doing resistance training exercises. |
| Comparator Agent |
Routine activity and diet |
30 min of walking or other moderate intensity exercise 5 days a week.
Continue taking your normal routine diet |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
3,6 and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
3, 6 & 12 months |
To assess the change in quality of life between the two groups using SF 36 questionnaire
|
baseline & 12 months |
| To determine the need for biologicals/colectomy in both group |
3, 6 & 12 months. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Improving muscle mass through nutrition, exercise, and optimized therapy may exert anti- inflammatory and immunomodulatory effects, improving disease activity indices in patients of UC and thereby preventing relapse . This study aims to investigate the effect of a combined dietary intervention and structured exercise regimen on the prevention of disease relapse in IBD patients with sarcopenia, thereby providing evidence for targeted, multidisciplinary management strategies in this high-risk population. |