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Clinical Trials/NCT04337671
NCT04337671
Completed
Not Applicable

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

Cairo University1 site in 1 country30 target enrollmentJune 2, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Artery Hypertension
Sponsor
Cairo University
Enrollment
30
Locations
1
Primary Endpoint
Subjective self-report questionnaire that assesses sleep quality
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 2, 2018
End Date
December 28, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heba Ahmed Ali Abdeen

Assistant Professor

Cairo University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Determining sleep patterns

Time Frame: change from baseline at 12 weeks

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

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.

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.

Study Sites (1)

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