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Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.

R

Riphah International University

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Other: Phase 1 Cardiac Rehabilitation
Other: Phase 1 Cardiac Rehabilitation with Lower Limb Paddling

Study type

Interventional

Funder types

Other

Identifiers

NCT04556994
REC/00699 Muhammad Faizan

Details and patient eligibility

About

To compare the effect of Phase 1 cardiac rehabilitation with lower limb paddling, with phase 1 cardiac rehabilitation without lower limb paddling Effects in Post Coronary artery bypass graft (CABG) Patients.

Full description

Coronary artery disease (CAD) is the most common type of heart disease. CAD happens when the arteries that supply blood to heart muscle become hardened and narrowed. This is due to the buildup of cholesterol and other material, called plaque, on their inner walls. This buildup is called atherosclerosis. As it grows, less blood can flow through the arteries. As a result, the heart muscle can't get the blood or oxygen it needs. This can lead to chest pain (angina) or a heart attack. Most heart attacks happen when a blood clot suddenly cuts off the hearts' blood supply, causing permanent heart damage.

Previous studies reported positive effects of early exercise in the ICU on these measures . In a meta-analysis published earlier, early mobilization increased the number of ventilator-free days during hospitalization, but not the duration of Minute ventilation (MV). A possible explanation is that many patients without MV were included . As a result, these results should be interpreted with caution. The mortality rate is a traditional measure of the health status of critically ill patients. Muscle weakness is associated with increased mortality. Physical therapy in the intensive care unit (ICU) had no effect on mortality in many previous systematic reviews and meta-analyses. Similar to previous studies, early mobilization did not improve ICU mortality, hospital mortality, or 28-day mortality rates in the previously published meta-analysis. The discharged-to-home rate is an important prognostic indicator for critically ill patients, first showed that early mobilization increased the discharged-to-home rate compared to the control group.

In previous study it was concluded that, after the performance of the mobilization protocol, the patients in the Immunoglobulins (IG) improved the distance walked in the 6 min walk test (6MWT), which was assessed during 7 postoperative days and 60 days after hospital discharge, and it was less time in ICU and lower prevalence of pulmonary complications, when compared to the control group (CG). It was also concluded that with the results obtained from their study, it was possible to introduce an early mobilization protocol in the ICU routinely unit and sensitize the medical board about the importance of proper physiotherapy conduct.

Another previously conducted study states that regardless of the different techniques and periods of mobilization applied, early mobilization may be initiated safely in the ICU setting and appears to decrease the incidence of Intensive care unit-acquired weakness (ICU-AW), improve the functional capacity, and increase the number of patients who are able to stand, number of ventilator-free days and discharged-to-home rate without increasing the rate of adverse events. However, due to the substantial heterogeneity among the included studies, the evidence has a low quality.

Previous study states the importance of this approach; this has been emphasized in previous studies on experienced paddlers, rowers, cross-country skiers, cyclists and runners. However, some studies in sports that depend upon a high lower extremity documented a dependence of results from a specific Paddler on the season when the test was undertaken. During paddling, ventilatory functions are also very important. Values for the maximal minute ventilation (Vmax) and tidal volume obtained in the cycle ergometer were higher than in paddling in previous studies. During endurance performance the tidal volume depends on age, sex and constitutional factors and, in athletes, mainly on the nature and duration.The Max oxygen consumption (VO2) differences between maximal cycling and paddling were non-significant in previous studies. The ventilation equivalent affords insight into the economy of respiration. The magnitude is dependent on constitutional factors, especially on morphological conditions of the respiratory system, and partly on sex, age and, especially in athletes, on the economy of ventilation.

Enrollment

54 patients

Sex

All

Ages

35 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Body mass index (BMI) between 20 and 30 kg/m2
  • Hemodynamic stability with or without use of positive inotropic drugs
  • Absence of arrhythmias and angina
  • Mean blood pressure (MBP) 60 ⩽ MBP ⩽ 100 mmHg
  • Heart rate (HR) 60 ⩽ HR ⩽ 100 bpm without respiratory distress
  • Respiratory rate (RR) ⩽ 20 without signs of infection

Exclusion criteria

  • Previous pulmonary disease and acute lung disease
  • Mechanical ventilation >24 h
  • Left ventricular ejection fraction (LVEF) <35% or >54%
  • Surgical reintervention
  • Intraoperative death or any contraindications for the proposed measurements and/or treatment
  • Contraindications for the 6MWT or any proposed protocol
  • Orthopedic impairments
  • Unstable angina
  • HR >120 bpm at rest, and systolic blood pressure >180 mmHg or diastolic >100 mmHg.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

Phase 1 Cardiac Rehabilitation
Active Comparator group
Description:
Phase 1 Cardiac Rehabilitation
Treatment:
Other: Phase 1 Cardiac Rehabilitation
Phase 1 Cardiac Rehabilitation with Lower Limb Paddling
Experimental group
Description:
Phase 1 Cardiac Rehabilitation with lower limb paddling
Treatment:
Other: Phase 1 Cardiac Rehabilitation with Lower Limb Paddling

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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