| CTRI Number |
CTRI/2025/09/095386 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| 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 nordic walking on lungs, fitness, and life quality in people with COPD |
|
Scientific Title of Study
|
EFFECT OF NORDIC WALKING ON PULMONARY FUNCTION, FUNCTIONAL CAPACITY AND QUALITY OF LIFE AMONG COPD INDIVIDUALS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anamika Rajpoot |
| Designation |
PG Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabiliation |
| Address |
Cardiothoracic and Pulmonary Disorder Lab Ground Floor, Department of Physiotherapy Maharishi Markandeshwar Institute of Physiotherapy and Rehabiliation
Mullana,Ambala Haryana
Ambala
HARYANA
133203
India |
| Phone |
8091765704 |
| Fax |
- |
| Email |
anamika15102001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mandeep K Jangra |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabiliation |
| Address |
Cardiothoracic and Pulmonary Disorder Lab Ground Floor, Department of Physiotherapy Maharishi Markandeshwar Institute of Physiotherapy and Rehabiliation
Department of Physiotherapy Maharishi Markandeshwar Institute of Physiotherapy and Rehabiliation
Ambala
HARYANA
133203
India |
| Phone |
9813397708 |
| Fax |
- |
| Email |
mandeep.jangra@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandeep K Jangra |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabiliation |
| Address |
Cardiothoracic and Pulmonary Disorder Lab Ground Floor, Department of Physiotherapy Maharishi Markandeshwar Institute of Physiotherapy and Rehabiliation
Ground Floor, Department of Physiotherapy Maharishi Markandeshwar Institute of Physiotherapy and Rehabiliation
Ambala
HARYANA
133203
India |
| Phone |
9813397708 |
| Fax |
- |
| Email |
mandeep.jangra@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Anamika Rajpoot
Department of Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabiliation , Mullana Ambala Haryana 133203 |
|
|
Primary Sponsor
|
| Name |
Anamika Rajpoot |
| Address |
Maharishi Markandeshwar Institue of Physiotherapy and Rehabilitation |
| 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 |
| Anamika Rajpoot |
Dr. Anamika Rajpoot |
Maharishi Markandeshwar Institue of Physiotherapy and Rehabilitation
Ambala
HARYANA |
8091765704
anamika15102001@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 Mullana, Ambala. Communication of Decision of the Ethics Committee (IEC) |
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 |
| Intervention |
Nordic Walking |
Patient will recieve interention for 6 weeks. In each week 3 sessions will be given. Every session will be of 40 minutes which consist 10 minutes of warm up, 20 minutes of nordic walking and 10 minutes of cool down. |
| Comparator Agent |
Pulmonary Rehabilitaion |
Patients in control group will receive purse lip breathing exercise, ACBT, inspiratory muscle training for 6 weeks. In each week there will be 3 sessions. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. GOLD stage II or IV (moderate to very severe COPD)
2. Able to walk independently without walking aids |
|
| ExclusionCriteria |
| Details |
1. Active smokers
2. Diagnosis other respiratory condition
3. Cardiac arrythmias
4. Disease that decreases exercise capacity (anemia, electrolyte imbalance)
5. Gait disorders
6. Acute MI in the last 6 months
7. Participation in any other exercise program in past 6 months
8. Resting heart rate of more than 120
9. Systolic blood pressure of more than 180 mm Hg, and Diastolic blood pressure of more than 100 mm Hg |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pulmonary Function (FEV1; FVC; FEV1/FVC)
|
Baseline and after 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Functional Capacity
2. Quality of Life |
Baseline and after 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
15/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/09/2025 |
| 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 randomization controlled trial will evaluate the effectiveness of Nordic walking on pulmonary function, functional capacity and quality of life among COPD individuals. Participants will be randomly allocated to nordic walking group or control group. |