| CTRI Number |
CTRI/2025/08/093060 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of chair aerobics on immune system in cancer patients |
|
Scientific Title of Study
|
Effect of Chair Aerobics on Patients Diagnosed with Solid Tumors using Immune Checkpoint Markers, Functional Mobility and Quality of Life: A Single Arm Clinical 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 |
Anushka Pillai |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Dr. D. Y. Patil College of Physiotherapy, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8390704765 |
| Fax |
|
| Email |
anushka.pillai@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Seema Saini |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Dr. D. Y. Patil College of Physiotherapy, Dr. D. Y. Patil Vidyapeeth, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8087564345 |
| Fax |
|
| Email |
seema.saini@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Anushka Pillai |
| Designation |
Assistant Professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8390704765 |
| Fax |
|
| Email |
anushka.pillai@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Physiotherapy, Dr. D. Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil College of Physiotherapy |
| Address |
Dr. D. Y. Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune 411018 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Anushka Pillai |
Dr. D. Y. Patil College of Physiotherapy |
Dr. D. Y. Patil Vidyapeeth
Sant Tukaram Nagar
Pimpri
Pune
MAHARASHTRA |
8390704765
anushka.pillai@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Dr. D. Y. PATIL COLLEGE OF PHYSIOTHERAPY, PIMPRI, PUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chair Aerobics |
The study will be explained in detail and a written informed consent will be
obtained from each one of them.
The demographic data shall be documented prior to the initiation of the
intervention.
The patients will be given 20 sessions of chair aerobics once a day, 5
days/week for 4 weeks.
The first week of exercise protocol will be delivered in the OPD under the
supervision of the physiotherapist. The remaining sessions will be delivered
via tele-rehabilitation.
Total duration of intervention will be 40 minutes.
Pre- and post-treatment assessments will include assessment of immune
checkpoint markers like PD-1/PD-L1, TIM-3, functional mobility and QoL.
The blood samples for testing activity of PD-1/PD-L1 and TIM-3 will be
taken by a trained nursing staff in the presence of the physiotherapist at the
start and end of the intervention at the same time of the day for both pre- and
post- values. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects, both males and females, in the age group of 40-64 years
2. Subjects who are known cases of solid tumors (carcinomas, sarcomas
and lymphomas) as diagnosed and referred by oncologists
3. Subjects who have no metastatic disease
4. European Cooperation Oncology Group (ECOG) performance status
score less than or equal to 1 (symptomatic, but able to carry out normal daily activities) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Immune checkpoint markers (PD-1/PD-L1 and TIM-3): Flow cytometry |
Baseline and 5 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed Up & Go test |
Baseline & 5 weeks |
| Functional Assessment of Cancer Therapy-General (FACT-G) |
Baseline & 5 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
25/10/2025 |
| 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="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
|
The proposed study investigates the effect of chair aerobics on immune
checkpoint markers such as TIM-3 and PD-1/PD-L1 in patients with solid tumors in
India. These immune checkpoints play a significant role in regulating immune responses
and are often dysregulated in cancer patients. Following cancer treatment, these markers
may suppress immune function, impeding recovery and increasing susceptibility to
recurrence. The study seeks to determine whether a chair aerobics program can modulate
these markers, potentially enhancing the body’s immune response and improving patient
outcomes.
This research is especially important in India, where cancer rates are high, and
access to advanced immunotherapies may be limited. Understanding how exercise can
influence immune regulation in cancer survivors could provide a cost-effective, non
pharmacological intervention to support recovery and prevent relapse. The findings could
lead to the integration of tailored exercise programs into post-cancer care protocols, not
only in India but also globally, offering a complementary approach to traditional cancer
treatments. |