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

NCT04337671 | Completed

• 1 other identifier: 2019HAHA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Artery Hypertension

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Determining sleep patterns

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

  change from baseline at 12 weeks

• 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

Study Arms (2)

Training group (A)

EXPERIMENTAL

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.

Other: Moderate intensity aerobic training

control group (B)

NO INTERVENTION

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

Interventions

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.

Training group (A)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: Males are selected because the functional capacity parameters measured maximum oxygen consumption(VO2 max) differs from males and females as it relies on body compostion , body size, amount of muscle mass and also on ventilatory parameters
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, 12316, Egypt

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 8, 2020
• Study Start: June 2, 2018
• Primary Completion: November 29, 2019
• Study Completion: December 28, 2019
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)