| CTRI Number |
CTRI/2026/01/100149 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of a Structured Exercise Program on Aerobic Fitness and Quality of Life in Thoracic Cancer Survivors |
|
Scientific Title of Study
|
Effectiveness of Structured Exercise Based Rehabilitation on Aerobic Performance and Quality of Life in Thoracic Malignancy Survivors: 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 Hardik Dilip Mhatre |
| Designation |
Post Graduate Student in Department of Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Physiotherapy, Latur, MIMSR Campus, Ambajogai Road, Latur 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
7276743870 |
| Fax |
02382-227246 |
| Email |
hardikdmhatre007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishvnath S Pawadshhetty |
| Designation |
Professor and HOD |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
MIMSR Medical College Campus, Vishwanathpuram, Ambejogai Road Latur 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
9422710990 |
| Fax |
02382-227246 |
| Email |
physiovish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishvnath S Pawadshhetty |
| Designation |
Professor and HOD |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
MIMSR Medical College Campus, Vishwanathpuram, Ambejogai Road Latur 413531
Latur
MAHARASHTRA
413531
India |
| Phone |
9422710990 |
| Fax |
02382-227246 |
| Email |
physiovish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiovascular and Respiratory Physiotherapy, Maharashtra Institute Physiotherapy, Latur, MIMSR Medical campus, Ambajogai Road, Latur-413531 |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of Physiotherapy, Latur, MIMSR Campus, Ambajogai Raod, Latur 413531 |
| Type of Sponsor |
Private medical college |
|
|
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 Vishvnath S Pawadshhetty |
Maharashtra Institute of Physiotherapy, Latur |
MIMSR Campus, Ambajogai Road, Latur 413531
Latur
MAHARASHTRA |
9422710990
physiovish@gmail.com |
| Dr Vishvnath S Pawadshetty |
Vivekanand Cancer and Superspeciality Hospital, Latur |
Vivekanand Cancer and Superspeciality Hospital, Latur
MIDC, LATUR 413512
Latur
MAHARASHTRA |
9422710990
physiovish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, (2) ICD-10 Condition: C383||Malignant neoplasm of mediastinum,part unspecified, (3) ICD-10 Condition: C37||Malignant neoplasm of thymus, (4) ICD-10 Condition: C33||Malignant neoplasm of trachea, (5) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Diaphragmatic Breathing Exercise
2. Aerobic Exercise
3. Bensons Relaxation Exercise |
Patients will be included according to inclusion criteria and selected with computer-generated randomization.
The patient will be given diaphragmatic breathing exercises for 5-10 mins, followed by aerobic exercise, including warmup and cooldown, for 20-30 mins, followed by Bensons relaxation for 5-10 mins. |
| Comparator Agent |
1.Diaphragmatic Breathing Exercise
2. Bensons Relaxation Exercise |
Patients will be included according to inclusion criteria and selected with computer-generated randomization. The patient will be given diaphragmatic breathing exercises for 5-10 mins, followed by Bensons relaxation for 5-10 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age- 18-60years (both male& female)
2. Patients diagnosed with lung, trachea, esophagus and mediastinal cancers.
3. Patients who are willing to participate.
4. Patients who can complete 6 min walk test. |
|
| ExclusionCriteria |
| Details |
1. Patients who have musculoskeletal impairments or injuries (e.g. any fractures or recent trauma)
2. Heart diseases (e.g. Hypertension, Arrythmia, Arterial hypertension)
3. Lung diseases (e.g., COPD or Asthma, Pneumonia)
4. Patients who require transfer to the intensive care unit for any reason will be excluded from the study.
5. Patients who have unstable vitals. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
6 min walk test
EQ-5D-5L questionnaire |
Both outcomes will be assessed at baseline and 2 weeks after completion of the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/01/2026 |
| 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 is a randomized control trial that is double blinded in nature.Subjects will be included according to inclusion and exclusion criteria. The entire procedure involved in the study will be explained to each subject. A written informed consent will be obtained from the participants. Demographic data of the participants will be collected. Patients will be assessed for 6 minute walk test & EQ-5D-5L questionnaire pre and post to intervention. Group A will receive an aerobic exercise protocol with conventional physiotherapy, including a relaxation technique with breathing exercises. Group B will receive conventional physiotherapy, including relaxation techniques with breathing exercises. The interventional exercise protocol will be carried out for 2 weeks daily, each exercise session includes 5-10 mins of warm-up, 20-30 mins of aerobic exercise, and 5-10 mins of cool-down, followed by Benson’s relaxation with breathing exercises for 15-20 mins. In the control group, patients will receive Benson’s relaxation with breathing exercises for 15-20 mins.
|