| CTRI Number |
CTRI/2018/11/016355 [Registered on: 15/11/2018] Trial Registered Prospectively |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Cardiac Autonomic Function in Chronic respiratory diseases; An Observational study |
|
Scientific Title of Study
|
Comparison of Cardiac Autonomic Function in Bronchiectasis and age matched healthy individuals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhiya Dinesh |
| Designation |
Bachelors in Physiotherapy |
| Affiliation |
School of Allied Health Sciences |
| Address |
School of Allied Health Sciences, Manipal Academy of Higher Education
Department of Physiotherapy, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA
Udupi 576104
India |
| Phone |
9483523913 |
| Fax |
|
| Email |
dia23195@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali K |
| Designation |
Head of Department |
| Affiliation |
School of Allied Health Sciences |
| Address |
School of Allied Health Sciences, Manipal Academy of Higher Education
Department of Physiotherapy, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA
Udupi 576104
India |
| Phone |
9483929754 |
| Fax |
|
| Email |
vaishali.kh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Anup Bhat |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
School of Allied Health Sciences, Manipal Academy of Higher Education
Department of Physiotherapy, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9916820026 |
| Fax |
|
| Email |
anup_251@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School of Allied health sciences, Manipal |
|
|
Primary Sponsor
|
| Name |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal |
| 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 |
| Dhiya Dinesh |
Kasturba Hospital |
Department of Physiotherapy, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9483523913
dia23195@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J47||Bronchiectasis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
CASES
1)Individuals with diagnosed case of bronchiectasis
2)Individuals with BMI within the range 18-25Kg/m2 of either gender
3)Individuals with stable breathlessness score[Modified Medical Research Council Dyspnoea Scale; grade 1-Breathlessness only with heavy exercises or grade 2- breathlessness when hurrying or walking up a slight hill] / Respiratory rate <30
4)Individuals with no symptoms of breathlessness and no hospital admissions in the previous week
CONTROLS
1)Healthy individuals
2)Age group and gender matched with case |
|
| ExclusionCriteria |
| Details |
CASES
1)Individuals with respiratory disorders other than bronchiectasis
2)Individuals with cardiac diseases such as heart failure, cardiac arrhythmia or coronary artery disease
3)Individuals on medications like vasodilators, antihypertensives and ACE inhibitors
4)Individuals with history of lung surgeries, diagnosis of cancer
CONTROLS
1)Individuals with known history of any systemic disease |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Heart rate variability parameters
2)FACED score |
8am- 11am |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)FACED SCORE |
8am - 11am |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
04/12/2018 |
| 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="2"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"None Yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an observational study. The main objective is to compare the heart rate variability in patients with Bronchiectasis and age group and gender matched healthy individuals. Eligible participants will be explained the procedure and a written informed consent will be given. Baseline measurements like age, gender, height, weight and smoking history will be noted. The test will be performed with the patient in supine lying. A 15 minutes rest period will be given prior to the test. After 15 minutes of rest, the POLAR transmitter will be connected on bare skin which will record the various parameters of heart rate variability. Once the heart rate variability is recorded for the case group, the same will be repeated with age and gender matched control group. |