Clinical trial NCT04624412: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 53
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Borg Scale Rate of Perceived Exertion
timeFrame: 6th week
measure: Fatigue Severity Scale
timeFrame: 6th week
measure: Mindfulness attention awareness scale
timeFrame: 6th week
measure: The Warwick Edinburgh mental Well- being scale
timeFrame: 6th week
measure: Patient Health Questionnaire
timeFrame: 6th week
measure: Ejection fraction
timeFrame: 6th week
measure: 6 min walk test: Distance (meters)
timeFrame: 6th week
measure: Pulse Rate
timeFrame: 6th week
measure: Oxygen Saturation (SpO2)
timeFrame: 6th week
measure: Systolic and diastolic blood pressure
timeFrame: 6th week
measure: Multidimensional assessment of fatigue
timeFrame: 6th week
measure: Lipid Profile test
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Rawalpindi Institute of Cardiology
state: Punjab
Study officials:
affiliation: Riphah International University
name: Iqbal Tariq, MSPT-CPPT
role: PRINCIPAL_INVESTIGATOR
References: