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

NCT ID: NCT04556994

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2020-12-30

Brief Summary

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.

Detailed 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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 Cardiac Rehabilitation

Phase 1 Cardiac Rehabilitation

Group Type: ACTIVE_COMPARATOR

Phase 1 Cardiac Rehabilitation

Intervention Type: OTHER

Step 1:Breathing exercises, 3 sets of 10 repetitions. Active upper and lower extremity exercises, 3 sets of 10 repetitions; bed inclined at 45°.

Step 2:Active exercises as in step 1. Stay in the upright position and perform walking on the spot for three series of 1 min.

Step 3:Active exercises as in step 2. Ambulation within the inpatient wards (7 min). Transfer to an allocated chair beside the bed (at least 30 min).

Step 4:Same exercises as in step 3. Ambulation within the inpatient wards (10 min). Transfer to an allocated chair beside the bed (at least 1 h).

Step 5:Same exercises as in step 4. Ambulation within the inpatient wards (15 min). Transfer to an allocated chair beside the bed (at least 2 h).

Step 6:Active exercises from the previous day. Ambulation within the inpatient wards (20 min). Step training (3 times continuously, 20 cm standardized step).

Step 7:Exercises from the previous day. Step training (6 times continuously, 20 cm standardized step).

Phase 1 Cardiac Rehabilitation with Lower Limb Paddling

Phase 1 Cardiac Rehabilitation with lower limb paddling

Group Type: EXPERIMENTAL

Phase 1 Cardiac Rehabilitation with Lower Limb Paddling

Intervention Type: OTHER

Step 1 to step 6 of Phase 1 Cardiac Rehabilitation given to the patients along with Lower limb exercise on Paddler lasting 20 min (5-min warm-up, 10 min of low-intensity exercise, and 5-min recovery), 30 rpm ( rotation per minute)

Interventions

Phase 1 Cardiac Rehabilitation

Step 1:Breathing exercises, 3 sets of 10 repetitions. Active upper and lower extremity exercises, 3 sets of 10 repetitions; bed inclined at 45°.

Step 2:Active exercises as in step 1. Stay in the upright position and perform walking on the spot for three series of 1 min.

Step 3:Active exercises as in step 2. Ambulation within the inpatient wards (7 min). Transfer to an allocated chair beside the bed (at least 30 min).

Step 4:Same exercises as in step 3. Ambulation within the inpatient wards (10 min). Transfer to an allocated chair beside the bed (at least 1 h).

Step 5:Same exercises as in step 4. Ambulation within the inpatient wards (15 min). Transfer to an allocated chair beside the bed (at least 2 h).

Step 6:Active exercises from the previous day. Ambulation within the inpatient wards (20 min). Step training (3 times continuously, 20 cm standardized step).

Step 7:Exercises from the previous day. Step training (6 times continuously, 20 cm standardized step).

Intervention Type: OTHER

Phase 1 Cardiac Rehabilitation with Lower Limb Paddling

Step 1 to step 6 of Phase 1 Cardiac Rehabilitation given to the patients along with Lower limb exercise on Paddler lasting 20 min (5-min warm-up, 10 min of low-intensity exercise, and 5-min recovery), 30 rpm ( rotation per minute)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iqbal Tariq, MsCPPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Rawal General & Dental Hospital

Islamabad, Fedral, Pakistan

Countries

Pakistan

References

Busch JC, Lillou D, Wittig G, Bartsch P, Willemsen D, Oldridge N, Bjarnason-Wehrens B. Resistance and balance training improves functional capacity in very old participants attending cardiac rehabilitation after coronary bypass surgery. J Am Geriatr Soc. 2012 Dec;60(12):2270-6. doi: 10.1111/jgs.12030. Epub 2012 Nov 23.

Reference Type: BACKGROUND

PMID: 23176104 (View on PubMed)

Salavati M, Fallahinia G, Vardanjani AE, Rafiei H, Mousavi S, Torkamani M. Comparison Between Effects of Home Based Cardiac Rehabilitation Programs Versus Usual Care on the Patients' Health Related Quality of Life After Coronary Artery Bypass Graft. Glob J Health Sci. 2015 Aug 19;8(4):196-202. doi: 10.5539/gjhs.v8n4p196.

Reference Type: BACKGROUND

PMID: 26573042 (View on PubMed)

Arefi S. Phase of cardiac rehabilitation programs on anxiety and depression in patients with acute coronary syndrome. 2012.

Reference Type: BACKGROUND

Sibilitz KL, Berg SK, Hansen TB, Risom SS, Rasmussen TB, Hassager C, Kober L, Gluud C, Thygesen LC, Lindschou J, Schmid JP, Taylor RS, Zwisler AD. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control: the CopenHeartVR trial. Trials. 2015 Feb 5;16:38. doi: 10.1186/s13063-015-0562-z.

Reference Type: BACKGROUND

PMID: 25887433 (View on PubMed)

Kang Y, Yang IS. Cardiac self-efficacy and its predictors in patients with coronary artery diseases. J Clin Nurs. 2013 Sep;22(17-18):2465-73. doi: 10.1111/jocn.12142. Epub 2013 Feb 27.

Reference Type: BACKGROUND

PMID: 23441807 (View on PubMed)

Borzou SR, Amiri S, Salavati M, Soltanian AR, Safarpoor G. Effects of the First Phase of Cardiac Rehabilitation Training on Self-Efficacy among Patients Undergoing Coronary Artery Bypass Graft Surgery. J Tehran Heart Cent. 2018 Jul;13(3):126-131.

Reference Type: BACKGROUND

PMID: 30745925 (View on PubMed)

Babu AS, Noone MS, Haneef M, Naryanan SM. Protocol-Guided Phase-1 Cardiac Rehabilitation in Patients with ST-Elevation Myocardial Infarction in A Rural Hospital. Heart Views. 2010 Jun;11(2):52-6. doi: 10.4103/1995-705X.73209.

Reference Type: BACKGROUND

PMID: 21187997 (View on PubMed)

Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.

Reference Type: BACKGROUND

PMID: 26419744 (View on PubMed)

Evans ES. Cardiovascular and blood lactate responses to low, moderate, and high intensity aerobic exercise in breast cancer patients: Is exercise intensity a true reflection of perceived exertion? : The University of North Carolina at Chapel Hill; 2008.

Reference Type: BACKGROUND

Whaley MH, Brubaker PH, Otto RM, Armstrong LE. ACSM's guidelines for exercise testing and prescription: Lippincott Williams & Wilkins; 2006.

Reference Type: BACKGROUND

Thow M. Exercise leadership in cardiac rehabilitation: an evidence-based approach: John Wiley & Sons; 2006.

Reference Type: BACKGROUND

De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.

Reference Type: BACKGROUND

PMID: 12472328 (View on PubMed)

Berry MJ, Morris PE. Early exercise rehabilitation of muscle weakness in acute respiratory failure patients. Exerc Sport Sci Rev. 2013 Oct;41(4):208-15. doi: 10.1097/JES.0b013e3182a4e67c.

Reference Type: BACKGROUND

PMID: 23873130 (View on PubMed)

Other Identifiers

REC/00699 Muhammad Faizan

Identifier Type: -

Identifier Source: org_study_id