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

NCT04337671 — Not applicable, Completed, 30 participants, Cairo University

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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

RegistryNCT04337671
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, supportive care
Enrollment30 (Actual)
SponsorCairo University (Other)
ConditionsPulmonary Artery Hypertension
InterventionsModerate intensity aerobic training (Other)
Datesstart 2018-06-02, primary completion 2019-11-29, completion 2019-12-28, first posted 2020-04-08, last updated 2020-04-08
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Pulmonary Artery Hypertension All trials of Moderate intensity aerobic training

-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).

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
Training group (A)ExperimentalOther: Moderate intensity aerobic trainingThe 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.
control group (B)No interventionControl group not receiving any training . They are taking their prescribed medications only.
  • Moderate intensity aerobic training (Other): 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.

+Outcome measures

Primary outcomes

  • Pulmonary artery systolic pressure (PASP) [change from baseline at 12 weeks]: Pulsed 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 quality [change from baseline at 12 weeks]: 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)
  • Determining sleep patterns [change from baseline at 12 weeks]: Determining sleep patterns by using actigraph to assess suspected certain sleep disorders,
  • Measuring aerobic fitness [change from baseline at 12 weeks]: Level of aerobic fitness assessed by using Cardiopulmonary exercise testing (CPET) through incremental exercise intensity until voluntary exhaustion.

+Eligibility

Sex: Male, ages: 45 Years to 65 Years

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

+Locations (1)

FacilityCityCountryStatus
Faculty of Physical TherapyCairoEgypt

+Publications

  • Results publication: Atef H, Abdeen H. Effect of exercise on sleep and cardiopulmonary parameters in patients with pulmonary artery hypertension. Sleep Breath. 2021 Dec;25(4):1953-1960. doi: 10.1007/s11325-020-02286-9. Epub 2021 Feb 18. PMID 33604801