Clinical trial NCT06312111: Physical Activity and Various Aspects of Quality of Life in Patients With Pulmonary Arterial Hypertension (Ph-PAH)
Official title: Assessment of Physical Activity and Various Aspects of Quality of Life in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Physical Inactivity
Keywords: pulmonary arterial hypertension
education
self-monitoring
physical activity
step count
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of steps per day
timeFrame: At baseline, after initial period 2 weeks
Secondary outcomes:
measure: Change in 6-minute walk distance
timeFrame: At baseline, 3 months
measure: Change in quality of life (SF-36)
timeFrame: At baseline, 3 months
measure: Change in the hospital anxiety and depression scale (HADS)
timeFrame: At baseline, 3 months
measure: Change in the acceptance of illness (AIS)
timeFrame: At baseline, 3 months
measure: Change in N-Terminal Pro-B-Type Natriuretic Peptide level (NT-proBNP)
timeFrame: At baseline, 3 months
measure: Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD
timeFrame: At baseline, 3 months
measure: Compliance with counting steps
timeFrame: at 3 months
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Centre, Otwock, Centre of Postgraduate Medical Education
state: Borowa 14/18
Study officials:
References: