| CTRI Number |
CTRI/2025/07/091133 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Effect of Walking with Sticks in Heart Surgery Patients on Cardiac and Pulmonary Functions |
|
Scientific Title of Study
|
Effect of Nordic Walking During Cardiac Rehab on cardiopulmonary parameters in post-op CABG: A Randomised Clinical 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 |
Prashansa Jain |
| Designation |
MPT Student |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Room No. 610, Delhi Pharmaceutical Sciences and Research University, School of Physiotherapy, Pushp Vihar, Sector-3, M.B. Road, New Delhi-110017, India
South
DELHI
110017
India |
| Phone |
8869839373 |
| Fax |
|
| Email |
jainprashansa9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tabassum Saher |
| Designation |
Assistant professor |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Room No. 610, Delhi Pharmaceutical Sciences and Research University, School of Physiotherapy, Pushp Vihar, Sector-3, M.B. Road, New Delhi-110017, India
South
DELHI
110017
India |
| Phone |
8700972875 |
| Fax |
|
| Email |
stabassumsaher@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prashansa Jain |
| Designation |
MPT Student |
| Affiliation |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Room No. 610, Delhi Pharmaceutical Sciences and Research University, School of Physiotherapy, Pushp Vihar, Sector-3, M.B. Road, New Delhi-110017, India
South
DELHI
110017
India |
| Phone |
8869839373 |
| Fax |
|
| Email |
jainprashansa9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Equipment from the Cardiopulmonary lab Room no. 610 at the School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University, Pushp Vihar, Sector-3, M.B. Road, New Delhi-110017, India will be utilized for this study |
| Nordic Sticks will be self funded |
|
|
Primary Sponsor
|
| Name |
Delhi Pharmaceutical Sciences and Research University |
| Address |
Room No. 610, Delhi Pharmaceutical Sciences and Research University, School of Physiotherapy, Pushp Vihar, Sector-3, M.B. Road, New Delhi-110017, India |
| Type of Sponsor |
Research institution |
|
|
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 Richa H Rai |
DPSRU Physiotherapy OPD |
Room No. 610, Physiotherapy OPD, New OPD Building, Delhi Pharmaceutical Sciences and Research University, Pushp Vihar, Sector-3, M.B. Road, New Delhi-110017, India
South
DELHI |
9350267077
richarai@dpsru.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I708||Atherosclerosis of other arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nordic Walking with physiotherapy exercises |
This group will participate in Nordic walking with physiotherapy exercises for 15 days. Walking with Nordic sticks will begin on day 5 postoperatively and will be conducted alongside conventional exercises. The treatment duration will be 15-30 minutes per day. Starting with 15 minutes per day on postoperative day 1, progressing to 30 minutes a day till postoperative day 15. |
| Comparator Agent |
Physiotherapy Exercises |
This group will receive conventional physiotherapy for 15 days. Walking without sticks will begin on day 5 postoperatively. The treatment duration will be 15-30 minutes per day. Starting with 15 minutes per day on postoperative day 1, progressing to 30 minutes a day till postoperative day 15. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Elective CABG surgery
2.LVEF percentage:more than 30 percent
3.NHYA classification: Class one and two
4.Subjects who understand Hindi and/or English are willing to give consent to participate |
|
| ExclusionCriteria |
| Details |
1.Unstable Angina Pectoris
2.Uncontrolled arrhythmias
3.Renal failure
4.Any life-threatening co-morbidities
5.Any locomotor or neurological disability (it may hamper the functional performance of the subject)
History of prior cardiac surgery, stroke, and pulmonary diseases (COPD, Asthma, TB, etc.) that can affect the outcome of the study
6.Active communicable disease |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Chest Expansion, Respiratory Rate, Resting Heart Rate, blood pressure, and Hand grip strength |
At Baseline (before the start of intervention)
On Postoperative Day 5 (after 5 sessions)
On Postoperative Day 10 (after 10 sessions)
On Postoperative Day 15 (after 15 sessions) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Functional capacity (6MWD), Sleep quality (PSQI), & Depression, Anxiety, & Stress (DASS-21) |
At Baseline (before the start of intervention)
On Postoperative Day 15 (after 15 sessions) |
| Pain (NPRS) |
At Baseline (before the start of intervention)
On Postoperative Day 5 (after 5 sessions)
On Postoperative Day 10 (after 10 sessions)
On Postoperative Day 15 (after 15 sessions) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/08/2025 |
| 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="2"
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
|
Nordic walking—a form of walking with specially designed poles which engages the upper body and improves walking efficiency and cardiovascular fitness, making it a beneficial addition to rehabilitation programmes. A randomised clinical trial will be conducted to explore the effects of cardiac rehabilitation incorporating Nordic walking on functional capacity and cardiopulmonary parameters in post-CABG patients. Initially, 30 subjects will be recruited by a convenient sampling method and then will be randomly allocated to two groups. An informed consent form will be obtained from the subjects. The intervention will be given for 15 days. A total of 15 sessions will be given in both groups. Pre-intervention assessment of chest expansion, resting heart rate, blood pressure, respiratory rate, hand grip strength, 6-minute walk distance, sleep quality, depression, anxiety, and stress will be conducted. Post-intervention evaluation for the same parameters will be done again by the end of the 5th, 10th, and 15th day, respectively. All the data will be compiled and statistically analysed to determine the effectiveness of Nordic walking on selected parameters in post-op CABG patients. |