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CTRI Number  CTRI/2025/12/099135 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 13/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effects of sub maximal exercise training in underwater treadmill COPD Patients 
Scientific Title of Study   Effects of sub maximal training in underwater treadmill on Lung Volume, Lung Capacity and Quality of life among Chronic obstructive pulmonary disease Patients 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CH ANAND CHELLAPPA 
Designation  Research Scholar 
Affiliation  RVS College of physiotherapy 
Address  RVS College of physiotherapy, Department of cardio-respiratory in Physiotherapy, Room-111, Sulur, Coimbatore.

Coimbatore
TAMIL NADU
641402
India 
Phone  9629733374  
Fax  04222687604  
Email  anandreena2016@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M K Franklin Shaju MPT PhD 
Designation  Professor 
Affiliation  RVS College of physiotherapy 
Address  RVS College of physiotherapy, Department of cardio-respiratory in Physiotherapy, Room-111, Sulur, Coimbatore.

Coimbatore
TAMIL NADU
641402
India 
Phone  9843671222  
Fax  04222687604  
Email  rvscpt@rvs group.com  
 
Details of Contact Person
Public Query  
Name  CH ANAND CHELLAPPA 
Designation  Research Scholar 
Affiliation  RVS College of physiotherapy 
Address  RVS College of physiotherapy, Department of cardio-respiratory in Physiotherapy, Room-111, Sulur, Coimbatore.

Coimbatore
TAMIL NADU
641402
India 
Phone  9629733374  
Fax  04222687604  
Email  anandreena2016@gmail.com  
 
Source of Monetary or Material Support  
Department of cardiorespiratory in Physiotherapy RVS College of physiotherapy Room 111 Sulur Coimbatore Coimbatore TAMIL NADU 641402 
 
Primary Sponsor  
Name  CHANAND CHELLAPPA 
Address  Department of cardiorespiratory in Physiotherapy RVS College of physiotherapy Room 111 Sulur Coimbatore Tamilnadu 641402 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
C H ANAND CHELLAPPA  Department of Cardio respiratory in physiotherapy Room no 111  RVS college of physiotherapy sulur coimbatore
Coimbatore
TAMIL NADU 		 08015935187
0422-2687604
anandreena2016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE RVS COLLEGE OF PHYSIOTHERAPY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sub maximal exercise training and Breathing exercises alone  Duration 6 weeks alternative-day sessions Study Design Experimental study (Pre test and Post test) Sampling Technique Convenience sampling Sample Size 32 COPD patients Setting RVS College of Physiotherapy Groups Group B Breathing exercises alone Outcome Measures: Pulmonary Function Test PFT Lung volume and capacity 
Intervention  Sub maximal Underwater treadmill training and Breathing exercises   Duration 6 weeks alternative-day sessions Study Design Experimental study (Pre test and Post test) Sampling Technique Convenience sampling Sample Size 32 COPD patients Setting RVS College of Physiotherapy Groups Group A Underwater treadmill and Breathing exercises Group B Breathing exercises only Outcome Measures: Pulmonary Function Test PFT Lung volume and capacity  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Male 
Details  Clinically diagnosed COPD patients falls in GOLD scale score 1and 2
Male subjects age from 40 to 55 year
Patients who can able to understand verbal comments.
 
 
ExclusionCriteria 
Details  Hydrophobia
Exercise induced sever shortness of breath
Cardiac diseases
Lung diseases other than COPD
Epilepsy
Physical disability
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pulmonary Function Test (PFT) – Lung volume & capacity
McGill COPD Quality of Life Questionnaire (QoL)
 		 Base line day 1 and 6 week
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   20/01/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  
Effects of Submaximal Underwater Treadmill Training on Lung Volume Lung Capacity and Quality of Life in Patients with Chronic Obstructive Pulmonary Disease COPD

Introduction
Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory condition characterized by airflow limitation breathlessness chest tightness mucus production and reduced physical tolerance Major contributing factors include smoking and environmental pollutants Due to decreased lung function and reduced exercise capacity, patients experience poor quality of life
Exercise training is considered an important component of pulmonary rehabilitation for COPD patients While several studies have evaluated land based submaximal and high-intensity training limited evidence is available on underwater treadmill based training which may offer advantages due to buoyancy reduced joint stress and improved respiratory mechanics

Need of the Study
Water-based training reduces the gravitational load improves ventilation, enhances balance and safety during exercise, and can improve functional capacity with less fatigue Since there is insufficient research on the effectiveness of submaximal underwater treadmill exercise in COPD this study aims to explore its impact on lung function and quality of life

Aim
To evaluate the effects of submaximal underwater treadmill exercise training on lung volumes lung capacities and quality of life in COPD patients

Objectives
To assess the improvements in lung function after underwater treadmill based submaximal exercise training with conventional physiotherapy
To assess the improvements in lung function following only conventional physiotherapy
To compare both treatment approaches to determine which is more effective

Hypothesis
There will be no significant difference between the effects of underwater treadmill based submaximal exercise and conventional physiotherapy alone on lung capacity and quality of life in COPD patients
Null hypothesis may be rejected if results are significant

Methodology
Study Design  Experimental study Pre test and Posttest
Sampling Technique  Convenience sampling
Sample Size  60 COPD patients
Duration  6 weeks alternative-day sessions
Setting  RVS College of Physiotherapy
Groups
Group A Underwater treadmill and Breathing exercises
Group B Breathing exercises only
Outcome Measures
Pulmonary Function Test PFT Lung volume and capacity
McGill COPD Quality of Life Questionnaire QOL

Expected Outcome
Underwater treadmill training may
Improve lung expansion due to hydrostatic pressure
 Enhance respiratory muscle efficiency
 Reduce dyspnea and fatigue
 Improve overall quality of life and pulmonary function better than conventional therapy alone

Conclusion
This study may provide scientific evidence supporting underwater treadmill based submaximal training as a safe and effective intervention in pulmonary rehabilitation for COPD patients

 
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