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Clinical Trials/CTRI/2024/05/067443
CTRI/2024/05/067443Not yet recruitingPhase 2/3

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.

Manju G2 sites in 1 country220 target enrollmentStarted: September 30, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
220
Locations
2
Primary Endpoint
To assess the level of Functional Status and Anxiety in control and experimental

Study Overview

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)

  1. 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

  1. To determine the level of acceptability of Prescribed Step-up Exercise Program (PSEP)

among experimental group of patients undergoing coronary artery bypass grafting

surgery.

  1. 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

  1. 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.

  1. 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.

  1. 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.

  1. 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.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
None

Eligibility Criteria

Ages
35.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients who are undergoing CABG surgery.
  • Willing to participate in the study.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

To assess the level of Functional Status and Anxiety in control and experimental

Time Frame: Postest 1 will be conducted seventh post operative day postest II will be conducted three weeks after the surgery

group of patients undergoing CABG surgery before and after

Time Frame: Postest 1 will be conducted seventh post operative day postest II will be conducted three weeks after the surgery

Prescribed step up Exercise Program (PSEP)

Time Frame: Postest 1 will be conducted seventh post operative day postest II will be conducted three weeks after the surgery

Secondary Outcomes

  • correlation between functional status and Anxiety in the control and(experimental group of patients undergoing CABG surgery)

Investigators

Sponsor
Manju G
Sponsor Class
Other [PHD Research Scholar- Self]
Responsible Party
Principal Investigator
Principal Investigator

Manju Sudhakar

Apollo College of Nursing

Study Sites (2)

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