| CTRI Number |
CTRI/2023/08/056554 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
12/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
the level of physical activity, barriers motivation faced by the heart failure patients during any physical activity visiting a hospital |
|
Scientific Title of Study
|
physical activity level, barriers and motivation while performing physical activity in heart failure patients visiting a tertiary care hospital in karnataka, India |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
faiqa hanif mansoor |
| Designation |
PG STUDENT |
| Affiliation |
KMC |
| Address |
kasturba medical college, department of physiotherapy, bejai,mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
7349353611 |
| Fax |
|
| Email |
faiqahanifs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vijay pratap singh |
| Designation |
Associate professor |
| Affiliation |
KMC |
| Address |
kasturba medical college, department of physiotherapy, bejai.mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8967035786 |
| Fax |
|
| Email |
vijaypratap.singh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr vijay pratap singh |
| Designation |
Associate professor |
| Affiliation |
KMC |
| Address |
kasturba medical college, department of physiotherapy, bejai.mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8967035786 |
| Fax |
|
| Email |
vijaypratap.singh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| KMC hospital, dr ambedkar circle mangalore |
|
|
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 faiqa |
KMC hospital,general wards |
KMC hospital ,Ambedkar circle ,Mangalore
Dakshina Kannada
KARNATAKA |
7349353611
faiqahanifs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INTERNATIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
irrespective of ejjection fraction
NYHA grade I-II |
|
| ExclusionCriteria |
| Details |
any cognitive impairment that might prevent the subjects from completing the questionnaire |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Short form IPAQ
Self efficacy scale
exercise motivation index |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to know how physicaly motivated/active heart failure patients are |
1 day |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
20/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2023 |
| 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 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
|
Demographic and clinical characteristics of all subjects included in the study will be recorded. a) After signing the consent form, willing volunteers will be evaluated for inclusion and exclusion criteria. 3 self-administered questionnaires will be given to the patients and data will be recorded. b) The exercise motivation index will be used to assess their motivation to engage in physical activity. c)The exercise self-efficiency scale will be used to identify potential barriers to performing physical activity. d) IPAQ scale will be used to assess their current level of physical activity |