| CTRI Number |
CTRI/2023/08/056977 [Registered on: 28/08/2023] Trial Registered Prospectively |
| Last Modified On: |
25/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
the relation between fatigue, pain, fear of movement and physical activity in coronary artery bypass grafting patients |
|
Scientific Title of Study
|
Association between fatigue, pain, kinesiophobia and physical activity in post coronary artery bypass grafting (CABG) patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fathma Samer |
| Designation |
PG STUDENT |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE |
| Address |
Kasturba Medical College, department of Physiotherapy, Bejai, Mangalore
Dakshina Kannada
Karnataka
575004
India
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9902149181 |
| Fax |
|
| Email |
fsamer86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay Pratap Singh |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore, MAHE |
| Address |
Kasturba Medical College, Department of Physiotherapy, Bejai, Mangalore
Dakshina Kannada
Karnataka
575004India
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 |
Kasturba Medical College, Mangalore, MAHE |
| Address |
Kasturba Medical College, Department of Physiotherapy, Bejai, Mangalore
Dakshina Kannada
Karnataka
575004India
KARNATAKA
575004
India |
| Phone |
8967035786 |
| Fax |
|
| Email |
vijaypratap.singh@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Mangalore, Dakshin Kannada, KARNATAKA, INDIA |
|
|
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 |
| Fathma Samer |
KMC hospital |
KMC Hospital, Ambedkar Circle, Mangalore
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA |
9902149181
fsamer86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KMC, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients who have undergone CABG |
|
| ExclusionCriteria |
| Details |
any cognitive impairment, neurological and musculoskeletal condition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Multidimensional Fatigue Inventory Scale
Tampa Scale for Kinesiophobia
Pain Catastrophizing Scale
6 minute walk test |
the above mentioned outcome measures will be taken at baseline only. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="95"
Sample Size from India="95"
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)
|
12/09/2023 |
| 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="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 wiling volunteers will be evaluated for inclusion and exclusion criteria. 3 self administered questionnaires will be given the patients and a 6 min walk test will be performed on them and the data will be recorded. b) multidimensional fatigue inventory scale will be used t evaluate fatigue c)Tampa scale for kinesiophobia will be used to evaluate kinesiophobia d) pain catastrophizing scale will be used to evaluate pain e) 6 min walk test will be done to evaluate physical activity. |