search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Phase 1 Cardiac Rehabilitation
Phase 1 Cardiac Rehabilitation with Lower Limb Paddling
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Cardiac Rehabilitation, CABG, Ergometer

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Rawal General & Dental Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Phase 1 Cardiac Rehabilitation

Phase 1 Cardiac Rehabilitation with Lower Limb Paddling

Arm Description

Phase 1 Cardiac Rehabilitation

Phase 1 Cardiac Rehabilitation with lower limb paddling

Outcomes

Primary Outcome Measures

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.
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)
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2020
Last Updated
January 12, 2021
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT04556994
Brief Title
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
Official Title
Comparison of Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Cardiac Rehabilitation, CABG, Ergometer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Cardiac Rehabilitation
Arm Type
Active Comparator
Arm Description
Phase 1 Cardiac Rehabilitation
Arm Title
Phase 1 Cardiac Rehabilitation with Lower Limb Paddling
Arm Type
Experimental
Arm Description
Phase 1 Cardiac Rehabilitation with lower limb paddling
Intervention Type
Other
Intervention Name(s)
Phase 1 Cardiac Rehabilitation
Intervention Description
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
Intervention Name(s)
Phase 1 Cardiac Rehabilitation with Lower Limb Paddling
Intervention Description
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)
Primary Outcome Measure Information:
Title
Functional independence
Description
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.
Time Frame
1 week
Title
Self-efficacy Formative Questionnaire
Description
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)
Time Frame
1 week
Title
Arterial blood gases (Ph)
Description
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.
Time Frame
1 week
Title
Ejection fraction
Description
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.
Time Frame
1 week
Title
Quality of Life SF-36 questionnaire
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqbal Tariq, MsCPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rawal General & Dental Hospital
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23176104
Citation
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. Erratum In: J Am Geriatr Soc. 2013 Mar;61(3):479.
Results Reference
background
PubMed Identifier
26573042
Citation
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.
Results Reference
background
Citation
Arefi S. Phase of cardiac rehabilitation programs on anxiety and depression in patients with acute coronary syndrome. 2012.
Results Reference
background
PubMed Identifier
25887433
Citation
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.
Results Reference
background
PubMed Identifier
23441807
Citation
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.
Results Reference
background
PubMed Identifier
30745925
Citation
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.
Results Reference
background
PubMed Identifier
21187997
Citation
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.
Results Reference
background
PubMed Identifier
26419744
Citation
Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Whaley MH, Brubaker PH, Otto RM, Armstrong LE. ACSM's guidelines for exercise testing and prescription: Lippincott Williams & Wilkins; 2006.
Results Reference
background
Citation
Thow M. Exercise leadership in cardiac rehabilitation: an evidence-based approach: John Wiley & Sons; 2006.
Results Reference
background
PubMed Identifier
12472328
Citation
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.
Results Reference
background
PubMed Identifier
23873130
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs