Heart DiseasesNCT04624412
Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2
A study testing Continuous Aerobic Moderate Intensity Exercise and Continuous Aerobic (Mild intensity Exercise) in people with Heart Diseases, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of different intensities of Continuous Aerobic Exercises on Fatigue levels, Mental Well- Being \& Mindfulness in Cardiac Rehab Phase 2. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Continuous Aerobic Moderate Intensity Exercise and Continuous Aerobic (Mild intensity Exercise)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Sep 2020to 30 Jan 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rawalpindi Institute of Cardiology
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effects of Different Intensities of Continuous Aerobic Exercises on Fatigue Levels, Mental Well-Being & Mindfulness in Cardiac Rehab Phase 2
To determine the effects of different intensities of Continuous Aerobic Exercises on Fatigue levels, Mental Well- Being \& Mindfulness in Cardiac Rehab Phase 2.
Read the 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.
- Conditions
- Heart Diseases
- Being tested
- Continuous Aerobic Moderate Intensity Exercise, Continuous Aerobic (Mild intensity Exercise)
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Aerobic Moderate Intensity ExerciseOther
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
Continuous Aerobic (Mild intensity Exercise)Other
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
| Study group | Role | What they receive |
|---|---|---|
| Continuous Aerobic Moderate Intensity Exercise | Experimental | (Treadmill walking exercise) 50% - 70% of max Heart Rate (HR) (3-6 METS) Receives: Other: Continuous Aerobic Moderate Intensity Exercise |
| Continuous Aerobic (Mild intensity Exercise) | Experimental | (Treadmill walking exercise) 30% -50 % of max HR (1-3 METS) Receives: Other: Continuous Aerobic (Mild intensity Exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6th week
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.
Measured: 6th week
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.
Measured: 6th week
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.
Measured: 6th week
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.
Measured: 6th week
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.
Measured: 6th week
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.
Measured: 6th week
Pulse Rate
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Measured: 6th week
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.
Measured: 6th week
Systolic and diastolic blood pressure
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Measured: 6th week
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.
Measured: 6th week
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).
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start8 Sep 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iqbal Tariq, MSPT-CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624412
- Sponsor's protocol ID
- REC/00711 Mehwish Iftikhar
- Status last verified
- Feb 2021
- First submitted
- 5 Nov 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Intensities of Continuous Aerobic Exercises on Fatigue Levels, Mental Well-Being & Mindfulness in Cardiac Rehab Phase 2
- ClinicalTrials.gov ID
- NCT04624412
- Acronym / sponsor ID
- REC/00711 Mehwish Iftikhar
- Conditions
- Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 10 Nov 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Aerobic Moderate Intensity Exercise | Experimental | Other: Continuous Aerobic Moderate Intensity Exercise(Treadmill walking exercise) 50% - 70% of max Heart Rate (HR) (3-6 METS) |
| Continuous Aerobic (Mild intensity Exercise) | Experimental | Other: Continuous Aerobic (Mild intensity Exercise)(Treadmill walking exercise) 30% -50 % of max HR (1-3 METS) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Continuous Aerobic Moderate Intensity ExerciseContinuous 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 | Other | Continuous Aerobic Moderate Intensity Exercise |
| Continuous Aerobic (Mild intensity Exercise)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 | Other | Continuous Aerobic (Mild intensity Exercise) |
Primary outcome
Borg Scale Rate of Perceived Exertion
Time frame: 6th week
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
Time frame: 6th week
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
Time frame: 6th week
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
Time frame: 6th week
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
Time frame: 6th week
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
Time frame: 6th week
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)
Time frame: 6th week
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
Time frame: 6th week
Changes from baseline, Pulse rate was measured per minute through pulse oximeter
Oxygen Saturation (SpO2)
Time frame: 6th week
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
Time frame: 6th week
Changes from the Baseline, Blood pressure is measured through sphygmomanometer
Multidimensional assessment of fatigue
Time frame: 6th week
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
Time frame: 6th week
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).
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 4 Feb 2021.
- 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, MSPT-CPPT 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 Continuous Aerobic Moderate Intensity Exercise and Continuous Aerobic (Mild intensity Exercise) in people with Heart Diseases, 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 5 inclusion and 6 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 4 Feb 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?
Borg Scale Rate of Perceived Exertion (time frame: 6th week). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2021.