| CTRI Number |
CTRI/2025/12/098595 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Three-Week Exercise program to improve the well-being of cancer patients during and after chemotherapy using St. Johns Cancer Recovery Exercise Plan |
|
Scientific Title of Study
|
A Three-Week Rehabilitation Program to Improve Quality of Life Among Patients Receiving and Recovering from Chemotherapy Using St. John’s Onco-Physiotherapy Protocol-An Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshmi M N |
| Designation |
MPT. Post Graduate Student |
| Affiliation |
Department of Physiotherapy. St Johns Medical College |
| Address |
Department of Physiotherapy, St. Johns Medical
College Hospital, Sarjapur Marathahalli Road, John Nagar,
Koramangala Bengaluru
Bangalore
KARNATAKA
560034
India
Bangalore
KARNATAKA
560034
India |
| Phone |
9741793662 |
| Fax |
|
| Email |
lakshminagaraj.nhlv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nischitha R Rao |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Department of Physiotherapy, St. Johns Medical
College Hospital, Sarjapur Marathahalli Road, John Nagar,
Koramangala Bengaluru
Bangalore
KARNATAKA
560034
India
Bangalore
KARNATAKA
560034
India |
| Phone |
9886882400 |
| Fax |
|
| Email |
nischitha.rao@stjohns.in |
|
Details of Contact Person
Public Query
|
| Name |
Nischitha R Rao |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Department of Physiotherapy, St. Johns Medical
College Hospital, Sarjapur Marathahalli Road, John Nagar,
Koramangala Bengaluru
Bangalore
KARNATAKA
560034
India
KARNATAKA
560034
India |
| Phone |
9886882400 |
| Fax |
|
| Email |
nischitha.rao@stjohns.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nischitha R Rao |
| Address |
AssistantProfessor.Department of Physiotherapy, St. Johns Medical
College Hospital, Sarjapur Marathahalli Road, John Nagar,
Koramangala Bengaluru
Bangalore
KARNATAKA
560034
India |
| Type of Sponsor |
Other [Self Fund] |
|
|
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 Nischitha R Rao |
St Johns Medical College Hospital |
31E, Medical Oncology. Oncology Block.
Bangalore
KARNATAKA |
9886882400
nischitha.rao@stjohns.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee.St Johns Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C189||Malignant neoplasm of colon, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
St. Johns Onco Physiotherapy Protocol |
The adapted physiotherapy protocol consists of three core exercises including aerobic, resistance, and flexibility training frequency-3 days in a week
time duration -60-90minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: patients 18 years to 80 years
2. Participants are eligible if they have received a minimum of one cycle of chemotherapy.
3. Patients with a diagnosis of breast cancer, pancreatic cancer, hematological cancer (lymphomas), or gastrointestinal cancer undergoing chemotherapy treatment.
4. World Health Organization performance status of 0 or 1.
5. Ability to read and understand English.
6. Ability to understand the informed consent form after being informed. |
|
| ExclusionCriteria |
| Details |
1.Patients with cognitive impairment—MMSE score less than 20
2. Brain, bone metastases, leukemia, and thrombocytopenia.
3.Myocardial infarction within the past three weeks, uncontrolled hypertension
4. Visual defect, vestibular defect, or both |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Life SF-36 |
Base line (day 1) and after week 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Brief Pain Inventory Scale-Short Form
30-second sit-to-stand test
30-second sit-to-stand test
6-minute walk test
Modified Fatigue Impact Scale
Tinetti Performance Oriented Mobility Assessment (POMA) |
baseline (day 1) and after week 3 |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/12/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This interventional study evaluates the efficacy of a three-week rehabilitation program based on the St. John’s Onco-Physiotherapy Protocol in improving quality of life among patients receiving and recovering from chemotherapy. Conducted at the Department of Medical Oncology, St. John’s Medical College Hospital, the program integrates aerobic, resistance, and flexibility exercises tailored for cancer patients. Key outcomes assessed include quality of life using Short Form 36, pain using the Brief Pain Inventory Short Form, upper and lower limb muscle strength using the 30 second arm curl test and 30 second sit to stand test, fatigue using Modified Fatigue Impact Scale, balance and gait using Tinetti Performance Oriented Mobility Assessment, and functional capacity using 6 Minute Walk Test. A purposive sample of 16 participants will undergo pre- and post-intervention evaluations. The study aims to provide evidence-based rehabilitation strategies to enhance physical and psychological well-being during and post chemotherapy.
|