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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04337671
Collaborator
(none)
30
1
2
18.9
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Moderate intensity aerobic training
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Impact of Aerobic Training on Sleep Quality and Aerobic Fitness in Male Patients With Pulmonary Artery Hypertension: a Randomized Control Study
Actual Study Start Date :
Jun 2, 2018
Actual Primary Completion Date :
Nov 29, 2019
Actual Study Completion Date :
Dec 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

No Intervention: control group (B)

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

Outcome Measures

Primary Outcome Measures

  1. Pulmonary artery systolic pressure (PASP) [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 [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 [change from baseline at 12 weeks]

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

  4. Measuring aerobic fitness [change from baseline at 12 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Physical Therapy Cairo Egypt 12316

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Heba Ahmed Ali Abdeen, Assistant Professor, Cairo University
ClinicalTrials.gov Identifier:
NCT04337671
Other Study ID Numbers:
  • 2019HAHA
First Posted:
Apr 8, 2020
Last Update Posted:
Apr 8, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2020