Interventional Effects on Myocardial Revascularization Post-surgical Patients

Effects of Continuous Positive Airway Pressure (CPAP)and Physical Exercise on Cycle Ergometer in Myocardial Revascularization Post-surgical Patients

The aim is to evaluate the effectiveness of physical exercise on a cycle ergometer combine with CPAP in the postoperative period after myocardial revascularization

Study Overview

• Status: Completed
• Conditions: Myocardial Revascularization
• Intervention / Treatment: Other: Conventional Therapy; Other: Cycle ergometer combine with CPAP

Detailed Description

Physical exercise on a cycle ergometer combine with CPAP as an adjunct to the rehabilitation of hospitalized subjects who will undergo myocardial revascularization will be safe, decrease the length of stay in the ICU, and help maintain functional capacity

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 43600
      • Rawalpindi Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who have undergone myocardial revascularization surgery
• An ejection fraction of greater than40%
• Post operative mechanical ventilation for <12hours
• No definite diagnosis of chronic obstructive pulmonary disease and asthma

Exclusion Criteria:

• With complications in post operative period (e.g., Artial fibrillation, prolonged mechanical ventilation)
• Hemodynamically unstable patients
• Intolerance to CPAP(continuous positive airway)mask

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional Therapy; The control program will consist of progressive exercises according to each postoperative day. Two daily sessions with an average duration of 25 min will be performed. In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform physical exercise on a cycle ergometer with CPAP.	Other: Conventional Therapy; Subjects will randomly placed into intervention group and control group . In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform physical exercise on a cycle ergometer with CPAP.
EXPERIMENTAL: Cycle ergometer combine with CPAP; Physical exercise on a cycle ergometer combine with CPAP will be performed in a single daily session from the second to the fourth postoperative days	Other: Cycle ergometer combine with CPAP; Physical exercise on a cycle ergometer combine with CPAP will be performed in a single daily session from the second to the fourth postoperative days . The maximum exercise time for postoperative day 2 will be 20 min, and 30 min for the third and fourth postoperative days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Borg scale	The Modified Borg Dyspnoea Scale is most commonly used to assess symptoms of breathlessness. Despite being a subjective measure of exercise intensity, RPE scales provide valuable information when used correctly.	4th day
6 min walk distance	The six minute walking test (6MWT) was developed by the American Thoracic Society and it was officially introduced in 2002, coming along with a comprehensive guideline. The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity	4th day
1 min sit to stand test	Vaidya et al reported that 1-minute STS test is a simple and sensitive test and appears to be a practical, reliable, valid, and responsive alternative for measuring exercise capacity, particularly where space and time are limited	4th day
Digital Monovacumeter	The manovacuometer is a simple, quick and non-invasive test which measures the maximal respiratory pressures (MRS).Digital manovacuometer is a reliable and valid instrument for assessing maximum inspiratory pressure and maximum expiratory pressure in healthy subjects	4th day

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2020
• Primary Completion (ACTUAL): August 20, 2021
• Study Completion (ACTUAL): August 20, 2021

Study Registration Dates

• First Submitted: March 6, 2021
• First Submitted That Met QC Criteria: March 6, 2021
• First Posted (ACTUAL): March 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: REC/00874 Arjumand Bano

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