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

Primary Purpose

Exercise

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Inspiratory muscle training
physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs.
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exercise focused on measuring functional capacity, lung capacity, rehabilitation

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National hospital Lahore.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Inspiratory muscle training and early ambulation

physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs.

Arm Description

Intervention group will be treated with Inspiratory muscle training once in a week for at least 3 weeks

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2023
Last Updated
July 7, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05936879
Brief Title
Effects of IMT ON Dyspnea, PF and Quality of Life in Patients With CABG
Official Title
Effects of IMT ON Dyspnea, PF and Quality of Life in Patients With CABG
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise
Keywords
functional capacity, lung capacity, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training and early ambulation
Arm Type
Experimental
Arm Description
Intervention group will be treated with Inspiratory muscle training once in a week for at least 3 weeks
Arm Title
physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs.
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs.
Intervention Description
Group B: Control group routine physical therapy including ankle pumps, hand pumps isometrics of upper and lower limbs
Primary Outcome Measure Information:
Title
6 Min walk test
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Spirometer:
Description
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
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iqbal Tariq, PHD
Phone
O3338236752
Email
iqbal.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Faisal, MS.CPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National hospital Lahore.
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sidra Faisal, MS.CPPT
Phone
03022001847
Email
sidra.faisal@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Fajar Inayat, DPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23917769
Citation
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.
Results Reference
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PubMed Identifier
25859310
Citation
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.
Results Reference
background
PubMed Identifier
20305920
Citation
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.
Results Reference
background
PubMed Identifier
17953516
Citation
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.
Results Reference
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Effects of IMT ON Dyspnea, PF and Quality of Life in Patients With CABG

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