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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04337671
Enrollment
30
Registered
2020-04-08
Start date
2018-06-02
Completion date
2019-12-28
Last updated
2020-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Artery Hypertension

Brief summary

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

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).

Interventions

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
45 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary artery systolic pressure (PASP)change from baseline at 12 weeksPulsed Doppler Echocardiogram for assessing PASP as calculated from the gradient across the tricuspid valve using the modified Bernoulli equation.
Subjective self-report questionnaire that assesses sleep qualitychange from baseline at 12 weeksThe 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)
Determining sleep patternschange from baseline at 12 weeksDetermining sleep patterns by using actigraph to assess suspected certain sleep disorders,
Measuring aerobic fitnesschange from baseline at 12 weeksLevel of aerobic fitness assessed by using Cardiopulmonary exercise testing (CPET) through incremental exercise intensity until voluntary exhaustion.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026