Effects of IMT ON Dyspnea, PF and Quality of Life in Patients With CABG

Patient in the Intervention group will be treated with routine pysical therapy, Inspiratory muscle training and early ambulation after surgery, whereas patients in the control group will be not be treated with these interventions and will rather undergo routine physical therapy (ankle pumps, hand pumps isometrics of upper and lower limbs).

Patients in the intervention group will receive treatment until discharge from hospital.

Study Overview

• Status: Recruiting
• Conditions: Exercise
• Intervention / Treatment: Other: Inspiratory muscle training; Other: physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs.

Detailed Description

A randomized control trial in which two groups one is intervention and the other is controlled group .Patient in the Intervention group will be treated with routine pysical therapy, Inspiratory muscle training and early ambulation after surgery, whereas patients in the control group will be not be treated with these interventions and will rather undergo routine physical therapy (ankle pumps, hand pumps isometrics of upper and lower limbs).

Patients in the intervention group will receive treatment until discharge from hospital. On the day of discharge they will be assessed using 6 minute walk test, Borg rate of perceive exertion and health related quality of life scale. Data will be analyzed using SPSS 25.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iqbal Tariq, PHD; Phone Number: O3338236752; Email: iqbal.tariq@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Recruiting
      • National hospital Lahore.
      • Contact: Sidra Faisal, MS.CPPT; Phone Number: 03022001847; Email: sidra.faisal@riphah.edu.pk
      • Principal Investigator: Fajar Inayat, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Both Gender patients
• Patients who agreed to participate
• Age: 35 to 55

Exclusion Criteria:

• Patients with history of Angioplasty or CABG
• Chronic Renal failure
• Cardiac arrhythmias
• History of stroke
• Unstable angina

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory muscle training and early ambulation; Intervention group will be treated with Inspiratory muscle training once in a week for at least 3 weeks	Other: Inspiratory muscle training; Group A: Intervention group will be treated with Inspiratory muscle training and early ambulation and routine physical therapy including ankle pumps,hand pumps isometrics of upper and lower limbs after surgery
Experimental: physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs.; Control group routine physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs once in a week for at least 3 weeks	Other: physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs.; Group B: Control group routine physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Min walk test	The 6 min walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance.It is also use to monitor your response to treatments for heart lung and other health problems.Provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometer:	A spirometer is used to measure pulmonary function test including FVC, FEV1 and FEV1/FVC ratio. The normal values of FEV1/FVC ratio are >0.70 and FVC, FEV1 are >80% of predicted age	4 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Sidra Faisal, MS.CPPT, Riphah International University

Publications and helpful links

General Publications

• Pinheiro AR, Christofoletti G. Motor physical therapy in hospitalized patients in an intensive care unit: a systematic review. Rev Bras Ter Intensiva. 2012 Jun;24(2):188-96. English, Portuguese.
• Shakouri SK, Salekzamani Y, Taghizadieh A, Sabbagh-Jadid H, Soleymani J, Sahebi L, Sahebi R. Effect of respiratory rehabilitation before open cardiac surgery on respiratory function: a randomized clinical trial. J Cardiovasc Thorac Res. 2015;7(1):13-7. doi: 10.15171/jcvtr.2015.03. Epub 2015 Mar 29.
• Oliveira EK, Silva VZ, Turquetto AL. Relationship on walk test and pulmonary function tests with the length of hospitalization in cardiac surgery patients. Rev Bras Cir Cardiovasc. 2009 Oct-Dec;24(4):478-84. doi: 10.1590/s0102-76382009000500008. English, Portuguese.
• Caso G, Vosswinkel JA, Garlick PJ, Barry MK, Bilfinger TV, McNurlan MA. Altered protein metabolism following coronary artery bypass graft (CABG) surgery. Clin Sci (Lond). 2008 Feb;114(4):339-46. doi: 10.1042/CS20070278.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): September 15, 2023
• Study Completion (Estimated): November 20, 2023

Study Registration Dates

• First Submitted: June 14, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; functional capacity; lung capacity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Dyspnea
• Other Study ID Numbers: REC/RCR & AHS/23/0308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No