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

NCT04556994 | Completed DMC

• 1 other identifier: REC/00699 Muhammad Faizan
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Cardiac Rehabilitation; CABG; Ergometer

Outcome Measures

Primary Outcomes (5)

• Functional independence

  The Functional Independence Measure (FIM) is an 18-item measurement tool that explores an individual's physical, psychological and social function. The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention. The higher the score is for a task, the more independent a person is at performing the task. For example, a score of 1 indicates that a person needs total assistance with a task, while a score of 7 means a person can perform a task with complete independence.

  1 week

• Self-efficacy Formative Questionnaire

  The Self-Efficacy Formative Questionnaire was developed in 2015 by Research Collaboration. An extensive review of related research resulted in identifying the two components essential for developing self-efficacy. Positive self-efficacy increased when students both believe that ability can grow with effort, as well as believed in their abilities to meet specific goals. The questionnaire was tested for reliability using Cronbach's coefficient alpha2 Results are displayed on a 100-point scale. These scores can be interpreted similar to grades (e.g., 70-79 is a C)

  1 week

• Arterial blood gases (Ph)

  An arterial blood gas (ABG) test measures the acidity (pH) and the levels of oxygen and carbon dioxide in the blood from an artery. This test is used to check how well your lungs are able to move oxygen into the blood and remove carbon dioxide from the blood. Normal blood pH ranges from 7.35 to 7.45 this is slightly to the alkaline side of the scale. If the pH is at the low end of the scale or if it is actually below 7.35, the condition is acidemia. Thus if it above 7.45 it is described as alkalemia.

  1 week

• Ejection fraction

  Echocardiography is a test that uses sound waves to produce live images of your heart. The image is an echocardiogram. This test allows your doctor to monitor how your heart and its valves are functioning. Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. The heart contracts and relaxes. A normal heart's ejection fraction may be between 50 and 70 percent. A ejection fraction measurement under 40 percent may be evidence of heart failure or cardiomyopathy. EF from 41 to 49 percent may be considered "borderline." It does not always indicate that a person is developing heart failure. Instead, it may indicate damage, perhaps from a previous heart attack. An ejection fraction measurement higher than 75 percent may indicate a heart condition such as hypertrophic cardiomyopathy.

  1 week

• Quality of Life SF-36 questionnaire

  The Short Form 36 Health Survey Questionnaire (SF-36) questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). A final item, termed self-reported health transition, is answered by the client but is not included in the scoring process. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

  1 week

Study Arms (2)

Phase 1 Cardiac Rehabilitation

ACTIVE COMPARATOR

Phase 1 Cardiac Rehabilitation

Other: Phase 1 Cardiac Rehabilitation

Phase 1 Cardiac Rehabilitation with Lower Limb Paddling

EXPERIMENTAL

Phase 1 Cardiac Rehabilitation with lower limb paddling

Other: Phase 1 Cardiac Rehabilitation with Lower Limb Paddling

Interventions

Phase 1 Cardiac Rehabilitation 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

Phase 1 Cardiac Rehabilitation with Lower Limb Paddling 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)

Phase 1 Cardiac Rehabilitation with Lower Limb Paddling

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rawal General & Dental Hospital

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (13)

• 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.

  PMID: 23176104 BACKGROUND

• 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.

  PMID: 26573042 BACKGROUND

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

  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.

  PMID: 25887433 BACKGROUND

• 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.

  PMID: 23441807 BACKGROUND

• 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.

  PMID: 30745925 BACKGROUND

• 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.

  PMID: 21187997 BACKGROUND

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

  PMID: 26419744 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 12472328 BACKGROUND

• 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.

  PMID: 23873130 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Iqbal Tariq, MsCPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 21, 2020
• Study Start: September 8, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 30, 2020
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)