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NCT Number: NCT04337671

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

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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Key information

Conditions

Pulmonary Artery Hypertension Familial Primary Pulmonary Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy

Cairo, 12316, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pulmonary artery systolic pressure (PASP)

    Time frame: 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.

  2. Subjective self-report questionnaire that assesses sleep quality

    Time frame: 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)

  3. Determining sleep patterns

    Time frame: change from baseline at 12 weeks

    Determining sleep patterns by using actigraph to assess suspected certain sleep disorders,

  4. Measuring aerobic fitness

    Time frame: change from baseline at 12 weeks

    Level of aerobic fitness assessed by using Cardiopulmonary exercise testing (CPET) through incremental exercise intensity until voluntary exhaustion.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 8, 2020
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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