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

• Sponsor: Riphah International University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05936879
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6.2
• Patients Per Site Per Month: 7.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Exercise	Other: Inspiratory muscle training; Other: physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs.	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model 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.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.
• Masking: Single (Participant)
• Masking 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.
• Primary Purpose: Treatment
• Official Title: Effects of IMT ON Dyspnea, PF and Quality of Life in Patients With CABG
• Actual Study Start Date: May 15, 2023
• Anticipated Primary Completion Date: Sep 15, 2023
• Anticipated Study Completion Date: Nov 20, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 6 Min walk test [4 weeks]

   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.

Secondary Outcome Measures

1. Spirometer: [4 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National hospital Lahore.	Lahore	Punjab	Pakistan

Sponsors and Collaborators

• Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: Riphah International University
• ClinicalTrials.gov Identifier: NCT05936879
• Other Study ID Numbers: REC/RCR & AHS/23/0308
• First Posted: Jul 10, 2023
• Last Update Posted: Jul 10, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Riphah International University: functional capacity; lung capacity; rehabilitation
• Additional relevant MeSH terms: Dyspnea

Study Results

No Results Posted as of Jul 10, 2023