Physical Activity and Various Aspects of Quality of Life in Patients With Pulmonary Arterial Hypertension (Ph-PAH)

Not Applicable

Completed

• Conditions: Physical Inactivity; Pulmonary Arterial Hypertension
• Interventions: Behavioral: recommendation to increase physical activity

• Registration Number: NCT06312111
• Lead Sponsor: Centre of Postgraduate Medical Education

Brief Summary

Evaluate whether education, a simple doctor's recommendation to increase physical activity in inactive patients, and self-monitoring of physical activity using a pedometer were effective and beneficial for patients with pulmonary arterial hypertension (PAH)

Detailed Description

Each patient was educated about the benefits of PhA in PAH on the initial visit. Patients wore pedometers (Omron HJ-321-E) for 2 weeks. After PhA assessment, the patients were contacted by a physician. Patients who walked \<5,000 steps per day were recommended to increase PhA, and patients who walked ≥5,000 steps per day were recommended to maintain PhA. Patients wore pedometers for 3 months until their next visit. The primary endpoint was the number of steps after 12 weeks of the study; the secondary endpoint was the 6-minute walk test distance (6MWD), quality of life (SF-36), acceptance of the disease, and anxiety and depression level (HADS).

Study Timeline

• Study Start: 2021-04-22
• Primary Completion: 2021-07-15
• Study Completion: 2022-07-17
• Status Verified: 2024-03
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-08
• Last Update Submitted: 2024-03-08
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Age equal to or greater than 18 years
• PAH diagnosis according to current guidelines, confirmed by right heart catheterization
• optimal pharmacological treatment
• stable clinical condition at least 3 months before inclusion in the study
• Informed consent to participate in your own

Exclusion Criteria

• Age under 18 years
• a type of hypertension other than PAH
• a neurological or orthopedic disease that prevents walking and performing the 6-minute walk test
• mental illness that prevents cooperation and assessment of quality of life survey
• lack of consent to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A physically inactive subgroup	recommendation to increase physical activity	Patients who walked \<5,000 steps per day during the first two weeks
A physically active subgroup	recommendation to increase physical activity	Patients who walked \>5,000 steps per day during the first two weeks

Primary Outcome Measures

Name	Time	Method
Number of steps per day	At baseline, after initial period 2 weeks	Number of steps per day monitored by pedometer Omron HJ-321-E

Secondary Outcome Measures

Name	Time	Method
Change in 6-minute walk distance	At baseline, 3 months	Distance in six-minute walk test
Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD	At baseline, 3 months	WHO functional class assessment
Compliance with counting steps	at 3 months	Compliance with counting steps
Change in the hospital anxiety and depression scale (HADS)	At baseline, 3 months	level of anxiety and depression measured by hospital anxiety and depression scale (HADS)
Change in N-Terminal Pro-B-Type Natriuretic Peptide level (NT-proBNP)	At baseline, 3 months	Blood sample to measure the concentration of N-terminal Pro-B type natriuretic peptide
Change in quality of life (SF-36)	At baseline, 3 months	Change in quality of life recorded by patient questionnaire 36-Item Short Form Health Survey (SF-36)
Change in the acceptance of illness (AIS)	At baseline, 3 months	acceptance of illness measured by acceptance of illness scale (AIS)

Trial Locations

Locations (1)

Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Centre, Otwock, Centre of Postgraduate Medical Education; 🇵🇱 Otwock, Borowa 14/18, Poland