| CTRI Number |
CTRI/2026/02/103172 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| 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
|
Eccentric bicycle training for improving exercise capacity in chronic lung disease |
|
Scientific Title of Study
|
Effect of eccentric bicycle ergometer training on exercise capacity in patients with chronic obstructive pulmonary disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ida Grace S |
| Designation |
Pg Resident |
| Affiliation |
College of Physiotherapy, Sri Ramakrishna institute of Paramedical Sciences |
| Address |
3rd floor, 1st room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences, 395 Sarojini Naidu Road, Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
7094313066 |
| Fax |
|
| Email |
idagrace@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R Amutha |
| Designation |
Professor |
| Affiliation |
College of Physiotherapy, Sri Ramakrishna institute of Paramedical Sciences |
| Address |
3rd floor, 1st room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences, 395 Sarojini Naidu Road, Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9843255234 |
| Fax |
|
| Email |
ramuthakk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Amutha |
| Designation |
Professor |
| Affiliation |
College of Physiotherapy, Sri Ramakrishna institute of Paramedical Sciences |
| Address |
3rd floor, 1st room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences, 395 Sarojini Naidu road, Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9843255234 |
| Fax |
|
| Email |
ramuthakk@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Science |
|
|
Primary Sponsor
|
| Name |
Ida Grace S |
| Address |
3rd floor, 1st room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences, 395 Sarojini Naidu Road, Sidhapudur, Coimbatore-641044 |
| 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 |
| Dr Krishnakumar |
Sri Ramakrishna Multispeciality hospital, Coimbatore |
Department of Pulmonology, 1st floor, room number 20,395,sarojini naidu road, sidhapudur, coimbatore-641044
Coimbatore
TAMIL NADU |
7094313066
idagrace@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMAKRISHNA HOSPITAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
exercise training - concentric cycling |
Warm up 5 minute, forward pedaling for 10 minutes, 2minuties rest, forward pedaling for 10 minutes ,Cool down 5 minutes. Total duration 35 minutes
|
| Intervention |
exercise training -eccentric cycling |
Warm up 5 minute, backward pedaling for 10 minutes, 2minuties rest, backward pedaling for 10 minutes ,Cool down 5 minutes. Total duration 35 minutes |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Smoking (quit smoking atleast before 2 years)
Diagnosed with chronic obstructive pulmonary disease (COPD) based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Moderate to severe COPD (GOLD stage II–III).
Stable COPD no acute exacerbations previous one month of the study
Changes in medication for at least 4 weeks prior to enrollment.
Ability to participate in exercise training with informed consent
Usage of inhalers
|
|
| ExclusionCriteria |
| Details |
History of cardiovascular disease or other severe comorbidities.
Severe cognitive impairment or inability to follow instructions.
Current use of supplemental oxygen or severe hypoxemia during physical activity.
Participation in other structured rehabilitation programs during the study.
Recent lower limb injury
Musculoskeletal deformities
Mixed respiratory condition
Post MI less than 6 months
Unstable blood pressure
Neurological disorders
Post surgeries (cardiothoracic surgeries) less than 6 months
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Six-minute walk test |
6-minute walk distance test from baseline to post-intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pulmonary Function Test
2. COPD Assessment Test |
1.Baseline and post-intervention
2.Baseline and post-intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2026 |
| Date of Study Completion (India) |
25/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disorder associated with reduced exercise capacity, impaired pulmonary function, and poor quality of life. Pulmonary rehabilitation is a key component of COPD management; however, conventional exercise training is often limited by fatigability and exertional dyspnea. Eccentric bicycle ergometer training is a low metabolic cost, high-force exercise modality that may improve exercise tolerance with reduced symptom burden. This study aims to evaluate the effect of eccentric bicycle ergometer training on exercise capacity, pulmonary function, and quality of life in individuals with COPD, using the 6-minute walk test, pulmonary function tests, and the COPD Assessment Test. |