| CTRI Number |
CTRI/2025/12/099834 [Registered on: 26/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2026 |
| 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
|
Improving Lung Health After Tuberculosis Through Nordic Walking |
|
Scientific Title of Study
|
Impact of Nordic Walking as an adjunct to Pulmonary Rehabilitation on Pulmonary Functions, Functional Capacity, Dyspnea and Quality of Life in individuals with Pulmonary Tuberculosis Sequelae |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Urvashi |
| Designation |
PhD Scholar |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, Haryana- INDIA.
Ambala
HARYANA
133207
India |
| Phone |
9528739597 |
| Fax |
|
| Email |
urvashiphdscholar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Saxena |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, Haryana- INDIA.
Ambala
HARYANA
133207
India |
| Phone |
9958729161 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Saxena |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, Haryana- INDIA.
Ambala
HARYANA
133207
India |
| Phone |
9958729161 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, Haryana- INDIA. |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, Haryana- INDIA. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Akanksha Saxena |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Cardiopulmonary Physiotherapy Research Lab, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be) University, Mullana, Ambala, Haryana- INDIA.
Ambala
HARYANA |
09528739597
urvashiphdscholar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J479||Bronchiectasis, uncomplicated, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nordic Walking |
Nordic walking is a form of walking exercise that uses specially designed poles, to actively engage the upper body and involves coordinated movements of the arms, shoulders, trunk, and legs, resulting in a more dynamic and whole-body activity, having 20 minute session.4days/week and for 6 weeks time period. |
| Comparator Agent |
Pulmonary Rehabilitation |
Pulmonary rehabilitation involves warm- up exercise, endurance, resistance and respiratory muscle training followed by cool down session for 45 minute/session. Interventions for 4 time/week and for 6 weeks time period. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
•Pulmonary Tuberculosis with completed pharmacological treatment before 2 months or more.
•Sputum smear negative.
•Breathlessness modified Medical Research Council (MRC) dyspnea scale grade 2 or higher.
|
|
| ExclusionCriteria |
| Details |
•Pneumothorax, hemoptysis, significant secretions, oral lesions or oral bleeding.
•Mentally inadequate and orthopedic problems, gait disorders that could interfere with walking.
•Active smoker.
•Participation in a pulmonary rehabilitation program in the past 12 months.
•Comorbidities involving reduced ability to exercise: significant anemia, electrolyte imbalance or hyperthyroidism.
•Pregnant and lactating women.
•Chronic obstructive pulmonary disease, asthma, interstitial lung disease, cardiovascular diseases such as myocardial infarction, angina and congestive heart failure.
•Unstable angina, myocardial infarction, Resting Heart Rate more than 120 beat per minute. Systolic Blood Pressure more than 180mmHg, Diastolic BP more than 100mmHg. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Spirometry {Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), Forced Expiratory Volume in 1 second (FEV1)/ Forced Vital Capacity (FVC) ratio}
•Maximum Oxygen Uptake (VO2 max)
|
At baseline and after completion of 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•modified Medical Research Council scale (mMRC scale)
•Short Form -36 Health Survey (SF-36)
|
At baseline & after completion of 6th week |
|
|
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)
|
10/01/2026 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study examines the effectiveness of Nordic Walking as an adjunct to conventional pulmonary rehabilitation in individuals with pulmonary tuberculosis sequelae. Pulmonary TB sequelae often result in persistent airflow limitation, reduced exercise tolerance, increased dyspnea, and compromised quality of life despite completion of medical treatment. Nordic Walking, which incorporates upper-limb involvement using poles, promotes an upright posture, enhances thoracic mobility, and increases engagement of respiratory and peripheral muscles. When combined with standard pulmonary rehabilitation, this walking modality is expected to improve pulmonary function parameters, enhance functional capacity, reduce perceived breathlessness, and positively influence health-related quality of life. The study highlights Nordic Walking as a safe, feasible, and cost-effective exercise strategy that may augment the overall benefits of pulmonary rehabilitation in individuals with post-tuberculosis lung impairment. |