Coronary Artery DiseaseNCT04556994
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
A study testing Phase 1 Cardiac Rehabilitation and Phase 1 Cardiac Rehabilitation with Lower Limb Paddling in people with Coronary Artery Disease, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Phase 1 Cardiac Rehabilitation and Phase 1 Cardiac Rehabilitation with Lower Limb Paddling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Sep 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Orthopedic impairments
- Unstable angina
- HR >120 bpm at rest, and systolic blood pressure >180 mmHg or diastolic >100 mmHg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
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.
Read the 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
- Being tested
- Phase 1 Cardiac Rehabilitation, Phase 1 Cardiac Rehabilitation with Lower Limb Paddling
- Keywords
- Coronary Artery Disease, Cardiac Rehabilitation, CABG, Ergometer
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1 Cardiac RehabilitationOther
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 PaddlingOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Cardiac Rehabilitation | Active comparator | Phase 1 Cardiac Rehabilitation Receives: Other: Phase 1 Cardiac Rehabilitation |
| Phase 1 Cardiac Rehabilitation with Lower Limb Paddling | Experimental | Phase 1 Cardiac Rehabilitation with lower limb paddling Receives: Other: Phase 1 Cardiac Rehabilitation with Lower Limb Paddling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start8 Sep 2020
- Primary completion20 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqbal Tariq, MsCPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556994
- Sponsor's protocol ID
- REC/00699 Muhammad Faizan
- Status last verified
- Jan 2021
- First submitted
- 16 Sep 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23176104Salavati 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.
PubMed 26573042Arefi S. Phase of cardiac rehabilitation programs on anxiety and depression in patients with acute coronary syndrome. 2012.
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.
PubMed 25887433Kang 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.
PubMed 23441807Borzou 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.
PubMed 30745925Babu 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.
PubMed 21187997Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.
PubMed 26419744Evans 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.
Whaley MH, Brubaker PH, Otto RM, Armstrong LE. ACSM's guidelines for exercise testing and prescription: Lippincott Williams & Wilkins; 2006.
Thow M. Exercise leadership in cardiac rehabilitation: an evidence-based approach: John Wiley & Sons; 2006.
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.
PubMed 12472328Berry 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.
PubMed 23873130
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
- ClinicalTrials.gov ID
- NCT04556994
- Acronym / sponsor ID
- REC/00699 Muhammad Faizan
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Cardiac Rehabilitation, CABG, Ergometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Cardiac Rehabilitation | Active comparator | Other: Phase 1 Cardiac RehabilitationPhase 1 Cardiac Rehabilitation |
| Phase 1 Cardiac Rehabilitation with Lower Limb Paddling | Experimental | Other: Phase 1 Cardiac Rehabilitation with Lower Limb PaddlingPhase 1 Cardiac Rehabilitation with lower limb paddling |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase 1 Cardiac RehabilitationStep 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). | Other | Phase 1 Cardiac Rehabilitation |
| Phase 1 Cardiac Rehabilitation with Lower Limb PaddlingStep 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) | Other | Phase 1 Cardiac Rehabilitation with Lower Limb Paddling |
Primary outcome
Functional independence
Time frame: 1 week
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
Time frame: 1 week
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)
Time frame: 1 week
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
Time frame: 1 week
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
Time frame: 1 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 23176104Busch 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.
- Background: PubMed 26573042Salavati 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.
- BackgroundArefi S. Phase of cardiac rehabilitation programs on anxiety and depression in patients with acute coronary syndrome. 2012.
- Background: PubMed 25887433Sibilitz 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.
- Background: PubMed 23441807Kang 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.
- Background: PubMed 30745925Borzou 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.
- Background: PubMed 21187997Babu 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.
- Background: PubMed 26419744Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.
- BackgroundEvans 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.
- BackgroundWhaley MH, Brubaker PH, Otto RM, Armstrong LE. ACSM's guidelines for exercise testing and prescription: Lippincott Williams & Wilkins; 2006.
- BackgroundThow M. Exercise leadership in cardiac rehabilitation: an evidence-based approach: John Wiley & Sons; 2006.
- Background: PubMed 12472328De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iqbal Tariq, MsCPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 1 Cardiac Rehabilitation and Phase 1 Cardiac Rehabilitation with Lower Limb Paddling in people with Coronary Artery Disease, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence (time frame: 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556994, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.