| CTRI Number |
CTRI/2024/07/070388 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Is it possible to do improve post liver transplant outcomes using exercise and nutrition? |
|
Scientific Title of Study
|
To evaluate the feasibility and impact of a home based preoperative exercise and Nutrition intervention in patients with high liver frailty index on post liver transplant outcomes - a prospective interventional Trial |
| Trial Acronym |
PENUT Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Susan Paulin |
| Designation |
Associate Consultant |
| Affiliation |
Dr. Rela Institute and medical centre |
| Address |
Department of Liver transplant anaesthesia and critical care,
3 rd floor, ICU office,
Dr. Rela Institute and medical centre,
Chennai, TN, India
Shankar Nagar, Chrompet, Chennai - 44
Kancheepuram
TAMIL NADU
60043
India |
| Phone |
919994519890 |
| Fax |
|
| Email |
Susanvercetti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Susan Paulin |
| Designation |
Associate Consultant |
| Affiliation |
Dr. Rela Institute and medical centre |
| Address |
Department of Liver transplant anaesthesia and critical care,
3 rd floor, ICU office,
Dr. Rela Institute and medical centre,
Chennai, TN, India
Shankar Nagar, Chrompet, Chennai - 44
TAMIL NADU
60043
India |
| Phone |
919994519890 |
| Fax |
|
| Email |
Susanvercetti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Susan Paulin |
| Designation |
Associate Consultant |
| Affiliation |
Dr. Rela Institute and medical centre |
| Address |
Department of Liver transplant anaesthesia and critical care,
3 rd floor, ICU office,
Dr. Rela Institute and medical centre,
Chennai, TN, India
Shankar Nagar, Chrompet, Chennai - 44
TAMIL NADU
600043
India |
| Phone |
919994519890 |
| Fax |
|
| Email |
Susanvercetti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rela Institute and Medical centre
Department of Liver transplant anaesthesia and critical care,
3 rd floor, ICU office,RIMC, Chrompet,
Chennai, TN, India |
|
|
Primary Sponsor
|
| Name |
Dr. Rela Institute and Medical centre |
| Address |
Shankar Nagar, Chrompet, Chennai - 44 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Susan Paulin |
Dr. Rela Institute and Medical Centre |
Shankar Nagar, Chrompet, Chennai-44
Kancheepuram
TAMIL NADU |
919994519890
susanvercetti@gmail.com |
| Dr Akila Rajakumar |
Dr.Rela Institute & Medical center |
Department of Liver transplant anaesthesia and critical care, 3 rd floor, ICU office, Dr. Rela Institute and medical centre, Chennai, TN, India
Shankar Nagar, Chrompet, Chennai - 44
Kancheepuram
TAMIL NADU
60043
India
Kancheepuram
TAMIL NADU |
04466667777
drakila.rajakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-Dr. Rela Institute and medical centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not applicable |
| Intervention |
Physiotherapy exercises and diet advice |
Exercises for 30 mins to be done everyday until transplant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patient with chronic liver disease undergoing evaluation for liver transplantation with LFI above 4.8 at the institute would be considered for inclusion. |
|
| ExclusionCriteria |
| Details |
1.Patient not giving consent for the study or unable to give consent
2.Age ≤ 18y
3.Patients with acute liver failure
4. Patients in ICU for 2 weeks/ICU admission in past 2 weeks
5.Re transplantation
Not likely for follow up at the study centre. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess survival following liver transplantation |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess immediate postoperative recovery outcomes
2. To assess functional performance at the end of 3 months
3. To assess the nutritional status at end of 3 months.
4. To assess the quality of life at the end of 1 year post transplant |
90 days and 1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
01/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [susanvercetti@gmail.com].
- For how long will this data be available start date provided 15-07-2024 and end date provided 31-01-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Liver fraility index (LFI) assessment will be performed by the physiotherapist routinely for all liver transplant recipients as part of pre transplant evaluation. Patients with LFI above 4.0 will be enrolled in the study at the point of first contact. Dietary and exercise plan will be formulated as per the patient needs and capacity respectively. The patients will be educated regarding the need for the nutritional and exercise interventions. Fornightly compliance check will be performed telephonically or in person. Repeat assessment of LFI will be done a day prior to transplant. Post transplantation, limb and chest physiotherapy will commence from postoperative day 1 and dietician review will be taken once feeding can be started. During the time of discharge further dietary plans and exercise regimen will be provided to the patients. At the end of 3 months further review of nutritional status, functional capacity, LFI and quality of life will be done. Quality of life will be assessed repeated at the end of one year post transplantation. |