Interventional Effects on Myocardial Revascularization Post-surgical Patients

Myocardial Revascularization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790656
• Other study ID #: REC/00874 Arjumand Bano
• Status: Completed
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: September 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Revascularization

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Rawalpindi institute of cardiology	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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