| CTRI Number |
CTRI/2026/03/106246 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Therapeutic effects of K-taping following median sternotomy:a randomized control trial |
|
Scientific Title of Study
|
Therapeutic Effects of K-taping Following Median Sternotomy: A Randomized Control 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 |
Samana S Hullemane |
| Designation |
MPT |
| Affiliation |
Narayana Hrudayalaya Institute of Physiotherapy |
| Address |
Narayana Hrudayalaya Foundations,258/A, Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore
Bangalore
KARNATAKA
560099
India |
| Phone |
8431461748 |
| Fax |
|
| Email |
samanahullemane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Jain N |
| Designation |
Associate Professor |
| Affiliation |
Narayana Hrudayalaya Institute of Physiotherapy |
| Address |
#258/A, Health City, Bommasandra Industrial Area, Anekal taluk, Bangalore-560099
Bangalore
KARNATAKA
560099
India |
| Phone |
9731036223 |
| Fax |
|
| Email |
ndjk2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samana S Hullemane |
| Designation |
MPT |
| Affiliation |
Narayana Hrudayalaya Institute of Physiotherapy |
| Address |
Department of Physiotherapy, Narayana Hrudayalaya Foundations,258/A, Health City, Bommasandra Industrial Area, Anekal Taluk, Bangalore
Bangalore
KARNATAKA
560099
India |
| Phone |
18002121244 |
| Fax |
|
| Email |
samanahullemane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana hrudayalaya Institute of Cardiac Sciences, Health City Bommasandra Industrial Area, Anekal Taluk, Bangalore, 560099 |
| NIL |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Samana S Hullemane |
Narayana Hrydayalaya Institute of Cardiac Sciences |
Department of Physiotherapy,Room no 6, International wing #258/A, Bommasandra Industrial Area, Anekal Taluk, Bengaluru 560099
Bangalore
KARNATAKA |
8431461748
samanahullemane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I339||Acute and subacute endocarditis, unspecified, (2) ICD-10 Condition: I249||Acute ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio Taping with tension |
Following extubation, K-tape will be applied for 24 hours in the following pattern(single application) :2 I-Strips will be cut in the length measuring from medial angle of scapula to angle of 8th or 9th rib. Anchor will be the middle portion of the I-strip, applied inferior to the scapula. The upper end of the I-strip will be pulled superiorly over erector spinae muscles, anchored over the rhomboids. The lower end of the I-Strip will be pulled laterally over the serratus anterior, anchored to the 8th or 9th rib.
|
| Comparator Agent |
Kinesio Taping with zero tension(Sham taping) |
Following extubation, K-tape will be applied for 24 hours in the following pattern(single application) :2 I-Strips will be cut in the length measuring from medial angle of scapula to angle of 8th or 9th rib. Anchor will be the middle portion of the I-strip, applied inferior to the scapula. The upper end of the I-strip will be applied superiorly over erector spinae muscleswith no tension, anchored over the rhomboids. The lower end of the I-Strip will be applied laterally over the serratus anterior with no tension, anchored to the 8th or 9th rib. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cooperative and of sound mind
Undergoing cardiac surgery via median sternotomy approach
Underwent pre-operative physiotherapy assessment and incentive spirometer training
Able to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Unable to understand verbal instructions
Patients on invasive ventilator support
History of previous cardiac surgery
History of neurological disease
Cases of Chronic Obstructive Pulmonary Disorders
Untoward occurrences during surgery
Emergency cardiac surgery
Skin conditions such as major burns, psoriasis and allergic dermatitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Digital spirometry:
Forced Expiratory volume(FEV1)
Forced Vital Capacity(FVC)
FEV1/FVC |
Before application of intervention(baseline) and 24 hours after application of intervention(post intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain (VAS) |
Before application of intervention (baseline)and 24 hours after application of intervention (Post intervention) |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
27/03/2026 |
| 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="9"
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
|
This study is to evaluate the effects of k taping following median sternotomy to facilitate forced expiration and funtion duricardiac rehabilitation. Considering placebo effects, trial is conducted on two groups, one with tension taping and one with sham or zero tension taping. Outcome measures are FEV1 and FVC ratios. |