Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2
Primary Purpose
Heart Diseases
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Continuous Aerobic Moderate Intensity Exercise
Continuous Aerobic (Mild intensity Exercise)
Sponsored by

About this trial
This is an interventional treatment trial for Heart Diseases
Eligibility Criteria
Inclusion Criteria:
- New York Heart Association (NYHA) (class 1, class II)
- Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
- Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
- Post Coronary artery bypass grafting (CABG)
- Patients diagnosed with mild to moderate depression on basis of Patient Health Questionnaire (PHQ-9)
Exclusion Criteria:
- Recurrent myocardial ischemia or Infarction (MI)
- Unstable angina
- Any diagnosed psychological disease
- Patients with impaired cognition function
- Patients with severe life-limiting illness such as cancer, and renal failure.
- Congestive Heart failure
Sites / Locations
- Rawalpindi Institute of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Continuous Aerobic Moderate Intensity Exercise
Continuous Aerobic (Mild intensity Exercise)
Arm Description
(Treadmill walking exercise) 50% - 70% of max Heart Rate (HR) (3-6 METS)
(Treadmill walking exercise) 30% -50 % of max HR (1-3 METS)
Outcomes
Primary Outcome Measures
Borg Scale Rate of Perceived Exertion
Changes from the Baseline will be measured, This scale is from 6-20 , where 6 means no exertion at all and 20 means maximal exertion, A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
Fatigue Severity Scale
Changes from the Baseline will be measured, The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven-point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63.
Mindfulness attention awareness scale
Changes from the Baseline will be measured, The trait Mindfulness attention awareness scale (MAAS) is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. To score the scale simply compute the mean of the fifteen items. Higher scores reflect higher levels of dispositional mindfulness.
The Warwick Edinburgh mental Well- being scale
Changes from the Baseline will be measured, The Warwick-Edinburgh Mental Well being Scales (WEMWBS) were developed to enable the measuring of mental wellbeing in the general population and the evaluation of projects, programmes and policies which aim to improve mental well-being. The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental well-being, thereby making the concept more accessible. The scale has been widely used nationally and internationally for monitoring, evaluating projects and programmes and investigating the determinants of mental wellbeing. The minimum scale score is 14 and maximum is 70. The scale is scored by summing responses to each item answered on a 1 to 5 likert scale.
Patient Health Questionnaire
The Patient Health Questionnaire (PHQ-9) is the depression module, which scores each of the nine Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. However, it can be used to make a tentative diagnosis of depression in at-risk populations - those with coronary heart disease or after stroke.
Ejection fraction
Changes from the Baseline will be measured, 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 (EF) 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.
6 min walk test: Distance (meters)
Changes from the baseline, 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.
Pulse Rate
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Oxygen Saturation (SpO2)
Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.
Systolic and diastolic blood pressure
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Multidimensional assessment of fatigue
Changes from the Baseline, The Multidimensional assessment of fatigue (MAF) is a 16 item scale that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue (over the past week, when it occurred and any changes), and its impact on various activities of daily living (household chores, cooking, bathing, dressing, working, socializing, sexual activity, leisure and recreation, shopping, walking, and exercising). Numerical rating scale (1 - 10) for items 1, and 4 - 14 ( 1 = not at all, 10 = a great deal), item 2 (1 = mild to 10 = severe), item 3 ( 1 = no distress, 10 = a great deal of distress). Categorical responses (1 - 4) for Timing items 15 and 16. A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.
Lipid Profile test
Changes from the Baseline was measure after taking blood samples, Lipid Profile test includes following: Low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL).
Secondary Outcome Measures
Full Information
NCT ID
NCT04624412
First Posted
November 5, 2020
Last Updated
February 3, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04624412
Brief Title
Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2
Official Title
Effects of Different Intensities of Continuous Aerobic Exercises on Fatigue Levels, Mental Well-Being & Mindfulness in Cardiac Rehab Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 30, 2021 (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 determine the effects of different intensities of Continuous Aerobic Exercises on Fatigue levels, Mental Well- Being & Mindfulness in Cardiac Rehab Phase 2.
Detailed Description
Physical activity has a strong association with health outcomes as it enhances physical and mental function by maximising cardio respiratory fitness and reduces the risk of multiple chronic diseases.
Aerobic exercise is the type of physical activity that accelerates and maintain fitness, well being and quality of life of human being. Aerobic means in presence of oxygen and is based on the power generating process by the utilization of oxygen as a major fuel to cope up the energy demands during sustained physical activity. During Aerobic exercise lungs get more efficient by enhancing their breathing capacity which leads to the removal of carbon dioxide and maximal utilization of oxygen and improvement of its transport to lungs and muscles by circulating blood. Aerobic is the form of exercise which helps in oxygen transportation and absorption while enhancing the efficiency of cardiovascular system. Long term aerobic exercises significantly affect the structure of heart and improve stroke volume of heart.
Fatigue is a feeling of tiredness and leads towards the inability of muscles to perform physically. It is mostly complained during cardiovascular disease and affects the functioning and quality of life in cardiac patients.
Mental well-being is an important constituent of health. Good mental health proves to be beneficial for patients' recovery and independency in activities of daily living. Chronic diseases have a very strong association with mental disorder.
Mindfulness is the ability to be fully alert and mental presence in the moment. Physical training boosts the mindfulness by enhancing the functioning of anterior cingulate cortex that has been linked to the improvement of self-regulation and attention. Aerobic exercises can improve the mood mindfulness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Aerobic Moderate Intensity Exercise
Arm Type
Experimental
Arm Description
(Treadmill walking exercise) 50% - 70% of max Heart Rate (HR) (3-6 METS)
Arm Title
Continuous Aerobic (Mild intensity Exercise)
Arm Type
Experimental
Arm Description
(Treadmill walking exercise) 30% -50 % of max HR (1-3 METS)
Intervention Type
Other
Intervention Name(s)
Continuous Aerobic Moderate Intensity Exercise
Intervention Description
Continuous Aerobic Moderate Intensity Exercise
5-10 min warm up
30 min moderate aerobic exercise (Treadmill walking exercise)
Constant intensity at 50% - 70% of max HR (3-6 METS)
5-10 min cool down
Intervention Type
Other
Intervention Name(s)
Continuous Aerobic (Mild intensity Exercise)
Intervention Description
Continuous Aerobic (Mild intensity Exercise)
5-10 min warm up
30 min mild aerobic exercise (Treadmill walking exercise)
Constant intensity at 30-50 % of max HR (1-3 METS)
5-10 min cool down
Primary Outcome Measure Information:
Title
Borg Scale Rate of Perceived Exertion
Description
Changes from the Baseline will be measured, This scale is from 6-20 , where 6 means no exertion at all and 20 means maximal exertion, A number is chosen by the patient in order to decide the best score that matches his level of dyspnea during physical activity.
Time Frame
6th week
Title
Fatigue Severity Scale
Description
Changes from the Baseline will be measured, The Fatigue Severity Scale (FSS) is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven-point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63.
Time Frame
6th week
Title
Mindfulness attention awareness scale
Description
Changes from the Baseline will be measured, The trait Mindfulness attention awareness scale (MAAS) is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. To score the scale simply compute the mean of the fifteen items. Higher scores reflect higher levels of dispositional mindfulness.
Time Frame
6th week
Title
The Warwick Edinburgh mental Well- being scale
Description
Changes from the Baseline will be measured, The Warwick-Edinburgh Mental Well being Scales (WEMWBS) were developed to enable the measuring of mental wellbeing in the general population and the evaluation of projects, programmes and policies which aim to improve mental well-being. The 14-item scale WEMWBS has 5 response categories, summed to provide a single score. The items are all worded positively and cover both feeling and functioning aspects of mental well-being, thereby making the concept more accessible. The scale has been widely used nationally and internationally for monitoring, evaluating projects and programmes and investigating the determinants of mental wellbeing. The minimum scale score is 14 and maximum is 70. The scale is scored by summing responses to each item answered on a 1 to 5 likert scale.
Time Frame
6th week
Title
Patient Health Questionnaire
Description
The Patient Health Questionnaire (PHQ-9) is the depression module, which scores each of the nine Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria as "0" (not at all) to "3" (nearly every day). It has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. However, it can be used to make a tentative diagnosis of depression in at-risk populations - those with coronary heart disease or after stroke.
Time Frame
6th week
Title
Ejection fraction
Description
Changes from the Baseline will be measured, 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 (EF) 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
6th week
Title
6 min walk test: Distance (meters)
Description
Changes from the baseline, 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.
Time Frame
6th week
Title
Pulse Rate
Description
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Time Frame
6th week
Title
Oxygen Saturation (SpO2)
Description
Changes from baseline SPO2 was measured in percentage. Oxygen immersion is the division of oxygen-soaked hemoglobin with respect to add up to hemoglobin in the blood. Pulse oximeter measure it.
Time Frame
6th week
Title
Systolic and diastolic blood pressure
Description
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Time Frame
6th week
Title
Multidimensional assessment of fatigue
Description
Changes from the Baseline, The Multidimensional assessment of fatigue (MAF) is a 16 item scale that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue (over the past week, when it occurred and any changes), and its impact on various activities of daily living (household chores, cooking, bathing, dressing, working, socializing, sexual activity, leisure and recreation, shopping, walking, and exercising). Numerical rating scale (1 - 10) for items 1, and 4 - 14 ( 1 = not at all, 10 = a great deal), item 2 (1 = mild to 10 = severe), item 3 ( 1 = no distress, 10 = a great deal of distress). Categorical responses (1 - 4) for Timing items 15 and 16. A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.
Time Frame
6th week
Title
Lipid Profile test
Description
Changes from the Baseline was measure after taking blood samples, Lipid Profile test includes following: Low-density lipoprotein cholesterol (LDL-C) at goal (<100mg/dL), high-density lipoprotein cholesterol (HDL-C) within normal range (40mg/dL for males and 50mg/dL for females), and/or triglycerides within normal range (≤ 150mg/dL).
Time Frame
6th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New York Heart Association (NYHA) (class 1, class II)
Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Post Coronary artery bypass grafting (CABG)
Patients diagnosed with mild to moderate depression on basis of Patient Health Questionnaire (PHQ-9)
Exclusion Criteria:
Recurrent myocardial ischemia or Infarction (MI)
Unstable angina
Any diagnosed psychological disease
Patients with impaired cognition function
Patients with severe life-limiting illness such as cancer, and renal failure.
Congestive Heart failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqbal Tariq, MSPT-CPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rawalpindi Institute of Cardiology
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2
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