Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension

Study Overview
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Brief Summary
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This study investigated the effect of 12 weeks of aerobic training on sleep quality and aerobic fitness in patients with Pulmonary arterial hypertension(PAH).

Detailed Description
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Thirty male PAH patients were included in the study. They were randomized into two equal groups; Training group (A) and Control group(B). Right ventricular systolic pressure (RVSP) measured using Doppler Echocardiography , Pittsburg sleep quality index (PSQI) questionnaire with the wrist worn actigraph used for the assessment of sleep disturbance, and Cardiopulmonary exercise testing (CPET) measurements included maximal heart rate and VO2max .All were measured before and after the study period for both groups.The training was a moderate intensity aerobic training on a bicycle ergometer (corresponding to 60% to 70% of the maximal heart rate they reach during peak oxygen uptake in the initial exercise test) for 30 to 45 min/day, 3 sessions/week for 12 weeks (36 sessions).

Official Title
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Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension: a Randomized Control Study

Conditions
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Pulmonary Artery Hypertension

Intervention / Treatment
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* Other: Moderate intensity aerobic training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were clinically stable and compensated under optimized medical therapy World health organization (WHO) Classification of functional class II to III PAH Patients with ejection fraction ≥ 40% Non-smokers body mass index ≤ 35 kg/m2 Exclusion Criteria: Any patient with respiratory failure unstable angina renal, hepatic or neuromuscular disorders history of syncopal attacks uncontrolled systemic hypertension peripheral vascular disease serious cardiac dysrhythmias on resting ECG evidence of severe COPD at pulmonary function testing, any known musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training group (A)<br>The training was a moderate intensity aerobic training on a bicycle ergo-meter(corresponding to 60% to 70% of the maximal heart rate they reach during peak oxygen uptake in the initial exercise test) for 30 to 45 min/day, 3 sessions/week for 12 weeks (36 sessions). In addition to their prescribed medications. | Other: Moderate intensity aerobic training<br>* The exercise program consisted of 5 minutes warm-up, 15-30 minutes of moderate aerobic exercises and 10 minutes cool-down, respectively. Frequency: 3 sessions/week , and Duration:12 weeks.<br>|
| No Intervention: control group (B)<br>Control group not receiving any training . They are taking their prescribed medications only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary artery systolic pressure (PASP) | Pulsed Doppler Echocardiogram for assessing PASP as calculated from the gradient across the tricuspid valve using the modified Bernoulli equation. | change from baseline at 12 weeks | 
| Subjective self-report questionnaire that assesses sleep quality | The Pittsburgh Sleep Quality Index is a subjective self-report questionnaire that assesses sleep quality over a 1-month time interval in different populations It is 5 points score (0 means normal, 5 means severe sleep disturbance) | change from baseline at 12 weeks | 
| Determining sleep patterns | Determining sleep patterns by using actigraph to assess suspected certain sleep disorders, | change from baseline at 12 weeks | 
| Measuring aerobic fitness | Level of aerobic fitness assessed by using Cardiopulmonary exercise testing (CPET) through incremental exercise intensity until voluntary exhaustion. | change from baseline at 12 weeks |