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

NCT ID: NCT04337671

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-02
• Study Completion Date: 2019-12-28

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).

Conditions

Pulmonary Artery Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Training group (A)

The 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.

Group Type: EXPERIMENTAL

Moderate intensity aerobic training

Intervention Type: 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.

control group (B)

Control group not receiving any training . They are taking their prescribed medications only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Heba Ahmed Ali Abdeen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 33604801 (View on PubMed)

Other Identifiers

2019HAHA

Identifier Type: -

Identifier Source: org_study_id