| CTRI Number |
CTRI/2024/05/067443 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Other (Specify) [Prescribed step up exercise program] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Prescribed step up exercise program upon functional status and anxiety among Coronary artery bypass surgery patients |
|
Scientific Title of Study
|
An evaluative study to determine the effectiveness of Prescribed step up exercise program upon functional status and anxiety among patients undergoing CABG at selected hospitals, Chennai. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manju Sudhakar |
| Designation |
Asst professor |
| Affiliation |
Apollo College of Nursing |
| Address |
Medical Surgical Nursing Department
IV floor
Room no 23
Apollo College of Nursing
Vanagaram to Ambattur Main Road Ayanambakkam Chennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
6380157322 |
| Fax |
|
| Email |
Manjusudhakar660@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sasikala D |
| Designation |
Professor |
| Affiliation |
Apollo College of Nursing |
| Address |
Medical Surgical Nursing Department
IV floor 31
Apollo College of Nursing
Vanagaram to Ambattur Main Road Ayanambakkam Chennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
9841964222 |
| Fax |
|
| Email |
sagasi143@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manju Sudhakar |
| Designation |
Asst professor |
| Affiliation |
Apollo College of Nursing |
| Address |
Medical Surgical Nursing department
IV Floor Room no 23
Apollo College of Nursing
Vanagaram to Ambattur Main Road Ayanambakkam Chennai 600095
Chennai
TAMIL NADU
600095
India |
| Phone |
6380157322 |
| Fax |
|
| Email |
Manjusudhakar660@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Specialty Hospitals
Vanagaram to Ambattur main road
Ayanambakkam
Chennai 600095 |
|
|
Primary Sponsor
|
| Name |
Manju G |
| Address |
Apollo College of Nursing
Vanagaram to Ambattur Main road
Chennai 600095 |
| Type of Sponsor |
Other [PHD Research Scholar- Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr sasikalaD |
Apollo Hospital vanagaram |
Vanagaram to ambattur main road
Ayanambakkam
Chennai-95, Medical Surgical Nursing,II Division .12
Chennai
TAMIL NADU |
9841964222
sagasi143@gmail.com |
| ManjuG |
Apollo college of nursing |
Apollo college of nursing
Ambattur to vanagaram main road
Ayanambkkam, chennai-95 ,Medical surgical Nursing,
Teaching 34
Chennai
TAMIL NADU |
6380157322
manjusudhakar660@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC of Apollo College of Nursing |
Approved |
| IEC of Apollo College of Nursing |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I209||Angina pectoris, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Prescribed Step of Exercise Program (PSEP) |
It refers to a motivational walking program schedule with warm up and cool
down phases for patients undergoing CABG surgery to increase and maintain physical
activity, incorporated with measuring the distance walked and monitoring for oxygen
saturation, blood pressure, heart rate and rate of perceived exertion. The patients will be
made to walk on a flat hard surface for a period of 6 minutes, once a day for 6 days a
week and the distance walked by them will be measured each day [2 nd postoperative day
to 7 th day].While Walking the patients will be assisted by the researcher with instructions
9
of do’s & dont’s and encouraged through positive reinforcement and also provide
feedback of their performance . |
| Intervention |
Prescribed step up exercise program |
for patients undergoing CABG surgery to increase and maintain physical activity, incorporated with measuring the distance walked and monitoring for oxygen saturation, blood pressure, heart rate and rate of perceived exertion. The patients will be made to walk on a flat hard surface for a period of 6 minutes, once a day for 6 days a week and the distance walked by them will be measured each day [2 nd postoperative day to 7 th day].While Walking the patients will be assisted by the researcher with instructions 9 of do’s & dont’s and encouraged through positive reinforcement and also provide feedback of their performance . |
|
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Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are undergoing CABG surgery.
Available at the time of data collection.
Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Patients with orthopedic conditions that would prohibit walking.
Patients who have severe visual and hearing problem.
Physically challenged and major health problem.
EF 35% before surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the level of Functional Status and Anxiety in control and experimental
group of patients undergoing CABG surgery before and after
Prescribed step up Exercise Program (PSEP) |
Postest 1 will be conducted seventh post operative day postest II will be conducted three weeks after the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
correlation between functional status and Anxiety in the control and
experimental group of patients undergoing CABG surgery
association between selected demographic variables and functional
Status in the control and experimental group of patients undergoing CABG surgery |
Postest 1 will be conducted seventh post operative day postest II will be conducted three weeks after the surgery |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response (Others) - NIL
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
Response (Others) - NIL
- Who will be able to view these files?
Response (Others) - NIL
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 11-02-2025 and end date provided 11-12-2026?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
An Evaluative Study to Assess the Effectiveness of Prescribed step up Exercise Program (PSEP) upon Functional Status and Anxiety among Patients undergoing CABG surgery in Selected Hospitals, Chennai. Primary Objectives
1. To assess the level of Functional Status and Anxiety in control and experimental group of patients undergoing coronary artery bypass grafting surgery before and after Prescribed Step-up Exercise Program (PSEP) 2. To determine the effectiveness of Prescribed Step-up Exercise Program (PSEP) upon Functional Status and Anxiety among patients undergoing coronary artery bypass grafting surgery.
Secondary Objectives 3. To determine the level of acceptability of Prescribed Step-up Exercise Program (PSEP) among experimental group of patients undergoing coronary artery bypass grafting surgery. 4. To find out the association between selected demographic variables and functional Status in the control and experimental group of patients undergoing coronary artery bypass grafting surgery 5. To find out the association between selected demographic variables and Anxiety in the control and experimental group of patients undergoing coronary artery bypass grafting surgery. 6. To find out the association between selected clinical variables and Functional Status in the control and experimental group of patients undergoing coronary artery bypass grafting surgery. 7. To find out the association between selected clinical variables and Anxiety in the control and experimental group of patients undergoing coronary artery bypass grafting surgery. 8. To find the correlation between functional status and Anxiety in the control and experimental group of patients undergoing coronary artery bypass grafting surgery.
Research Methodology
Research Approach An Evaluative approach will be used in this study. Research Design A Quasi Experimental – Pre test – Post test Research design will be used. O 1 O 2 O 3 O 4
O 1 X O 2 X O 3 X O 4 O 1 - Pretest of functional status and Anxiety among patients undergoing Coronary artery bypass grafting surgery X- Prescribed step-up exercise program. Breathing exercise every 3 hours and walking exercise given for 6 minutes each day, for 6 days followed by explanation for each person.
O 2 –Posttest 1- Assessment of functional status before and after the six minute walking among patients undergoing Coronary artery bypass grafting surgery will be done on 2 nd postoperative day. Assessment of Anxiety after the Six minute walking program. O 3 –Posttest 2- Assessment of functional status before and after the six minute walking among patients undergoing Coronary artery bypass grafting surgery will be done on 7th postoperative day. Assessment of Anxiety after the Six minute walking program. O4 – Posttest3- After 4 weeks during follow up visit. |