| CTRI Number |
CTRI/2026/03/105718 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Treadmill Exercise versus Stationary Cycling on Lung Function and Quality of Life in Obese Adults with Mild Breathing Problems |
|
Scientific Title of Study
|
Evaluating the Impact of Treadmill Versus Cycle Ergo meter Interval Training on Pulmonary
Function, Cardio respiratory Parameters, and Quality of Life in Obese Adults with mild Pulmonary restriction: 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 |
Sonam Kumari |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh,India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7631822445 |
| Fax |
|
| Email |
sonamsingh2094@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajjad Alam |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh,India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9818879898 |
| Fax |
|
| Email |
sajjad.alam@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajjad Alam |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh,India
UTTAR PRADESH
203201
India |
| Phone |
9818879898 |
| Fax |
|
| Email |
sajjad.alam@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sonam Kumari |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh, India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Sonam Kumari |
Galgotias University |
E005 Physiotherapy Lab Galgotias University Yamuna expressway Greater noida
Gautam Buddha Nagar
UTTAR PRADESH |
7631822445
sonamsingh2094@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School ethics committee, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obesity with mild pulmonary restriction |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cycle Ergometer Interval Training |
participants will get supervised cycle ergometer exercise and it will be compare with treadmill exercise |
| Intervention |
treadmill exercise training |
Intervention Name:
Treadmill Interval Training will be given to the participant
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
obese according to WHO criteria
Diagnosis of mild pulmonary limitation
Provide written informed consent and agree to comply with study procedures.
Non-smoker
|
|
| ExclusionCriteria |
| Details |
Have moderate-to-severe pulmonary disease (e.g., moderate/severe COPD, uncontrolled asthma, or other significant respiratory conditions).
Have severe cardiovascular disease (e.g., unstable angina, recent myocardial infarction within 6 months, uncontrolled hypertension).
Have any musculoskeletal or neurological condition that limits safe participation in treadmill or cycle ergometer training.
Are currently pregnant or planning pregnancy during the study period.
Have participated in structured HIIT or other regular endurance training within the last 3 months.
Have any condition or medication use that could significantly affect cardiorespiratory responses to exercise (e.g., uncontrolled diabetes, beta-blocker therapy that cannot be safely adjusted).
Are unable or unwilling to provide informed consent or follow study protocols.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effects of treadmill versus cycle ergometer interval training on pulmonary function, cardiorespiratory parameters, and quality of life in obese adults.
|
At baseline and after four weeks of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the impact of both training modalities on health-related quality of life using standardized assessment tools.
|
At baseline and after four weeks of intervention. |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
30/03/2026 |
| 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="0"
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
|
Obesity is associated with reduced pulmonary function, impaired cardiorespiratory fitness, and decreased quality of life. Exercise training is an effective intervention to improve respiratory and cardiovascular health. Interval training using treadmill and cycle ergometer is commonly prescribed; however, there is limited evidence comparing their effects in obese adults with mild pulmonary restriction.
This randomized controlled trial aims to evaluate and compare the effects of treadmill interval training and cycle ergometer interval training on pulmonary function, cardiorespiratory parameters, and quality of life in obese adults with mild pulmonary restriction. Participants will be randomly assigned to either treadmill interval training or cycle ergometer interval training group. Both groups will undergo supervised exercise training for eight weeks.
Pulmonary function, cardiorespiratory parameters, and quality of life will be assessed at baseline and after completion of the intervention. The findings of this study will help determine the more effective exercise modality for improving respiratory function, physical fitness, and quality of life in obese individuals with mild pulmonary restriction. |