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

Pulmonary Artery Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337671
• Other study ID #: 2019HAHA
• Status: Completed
• Phase: N/A
• Start date: June 2, 2018
• Est. completion date: December 28, 2019

Study information

• Verified date: April 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 28, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Artery Hypertension

Intervention

Other:
• Moderate intensity aerobic training
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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Determining sleep patterns	Determining sleep patterns by using actigraph to assess suspected certain sleep disorders,	change from baseline at 12 weeks
Primary	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