| CTRI Number |
CTRI/2024/02/062225 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing strength of muscles of breathing between individuals with a heart disease and healthy individuals of same age and gender |
|
Scientific Title of Study
|
Comparison of Respiratory muscle strength in Chronic heart failure patients and age, gender matched healthy controls – A Comparative study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rachna Arora |
| Designation |
Assistant Professor |
| Affiliation |
Topiwala National Medical College and Dr B.Y.L. Charitable Hospital |
| Address |
OPD 24, PT School and Centre, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7738095911 |
| Fax |
|
| Email |
rachna2arora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rachna Arora |
| Designation |
Assistant Professor |
| Affiliation |
Topiwala National Medical College and Dr B.Y.L. Charitable Hospital |
| Address |
OPD 24, PT School and Centre, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7738095911 |
| Fax |
|
| Email |
rachna2arora@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shashwat Chankeshwara |
| Designation |
Post Graduate student |
| Affiliation |
Topiwala National Medical College and Dr B.Y.L. Charitable Hospital |
| Address |
OPD 24, PT School and Centre, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra
Mumbai
MAHARASHTRA
400008
India |
| Phone |
8237609645 |
| Fax |
|
| Email |
chankeshwarashashwat7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Topiwala National Medical College and Dr B.Y.L. Charitable Hospital |
|
|
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 |
| Dr Rachna Arora |
B.Y.L. Nair Charitable Hospital |
Intensive cardiac care unit (ICCU),Ground floor, OPD building, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central
Mumbai
MAHARASHTRA |
7738095911
rachna2arora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects (ECARP) PG Academic Committee T.N. Medical College and B.Y.L Nair Ch Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I501||Left ventricular failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Study Group
1. Chronic heart failure patients for more than 3 months and NYHA grade 1 and 2 on OPD basis.
2. LVEF less than 40%.
Control Group
1. Age and gender matched healthy individuals. |
|
| ExclusionCriteria |
| Details |
Study Group
1. Hospitalization history of more than a week within past 3 months.
2. Any cardiac surgery within past 6 months.
3. Class 3 and 4 angina pectoris on NYHA scale.
4. Recent STEMI or Acute coronary syndrome NSTEMI.
5. Complex arrhythmias.
6. Patients with conduction blocks (Grade 1,2,3).
7. Pre-existing relevant orthopedic, neurologic or infectious disease.
8. Uncontrolled hypertension with systolic BP more than 140 mm Hg and diastolic BP more than 90 mm Hg and resting heart rate more than 100 beats per min.
9. Patients receiving corticosteroids, hormones or any other chemotherapy treatment.
10. History of smoking.
Control Group
1. Unwillingness to participate in the study.
2. Uncontrolled hypertension with systolic BP more than 140 mm Hg and diastolic BP more than 90 mm
Hg and resting heart rate more than 100 beats per min.
3. Patients receiving corticosteroids, hormones or any other chemotherapy treatment.
4. History of smoking. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maximum Inspiratory Pressure and Maximum Expiratory Pressure |
06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="86" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2024 |
| Date of Study Completion (India) |
02/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Heart
failure is a common reason for hospitalization and is associated with high
health care costs and high symptom burden. In 2021, there were 56.5 million
(95% Uncertainty Interval (UI): 49.7 million to 63.7 million) prevalent cases
of heart failure globally. Heart failure is a highly prevalent condition,
particularly in older age groups. The aim of the study was to compare the respiratory muscle
strength in chronic heart failure patients and age, gender matched healthy
controls. 43 chronic heart failure patients and 43 age and gender matched
healthy controls were included in the study. MIP and MEP were used as outcome
measures to assess respiratory muscle strength using a micro-RPM device.
Statistically significant reductions were found in Maximal Inspiratory Pressure
(MIP) and Maximal Expiratory Pressure (MEP) in Chronic heart failure patients
(Group A) as compared to Age, gender matched healthy controls (Group B). Thus,
the study concluded that there was a significant reduction in respiratory
muscle strength in chronic heart failure patients as compared to age, gender
matched healthy controls. |