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

Assessment of Physical Activity and Various Aspects of Quality of Life in Patients With Pulmonary Arterial Hypertension

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06312111
Acronym
PhA-PAH
Enrollment
48
Registered
2024-03-15
Start date
2021-04-22
Completion date
2022-07-17
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Inactivity, Pulmonary Arterial Hypertension

Keywords

pulmonary arterial hypertension, education, self-monitoring, physical activity, step count

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).

Interventions

BEHAVIORALrecommendation to increase physical activity

education on the benefits of physical activity in PAH from the first visit and doctor's recommendation to increase physical activity above 5,000 steps a day in inactive patients and above 5,000 steps per person in active patients

Sponsors

Centre of Postgraduate Medical Education
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of steps per dayAt baseline, after initial period 2 weeksNumber of steps per day monitored by pedometer Omron HJ-321-E

Secondary

MeasureTime frameDescription
Change in quality of life (SF-36)At baseline, 3 monthsChange in quality of life recorded by patient questionnaire 36-Item Short Form Health Survey (SF-36)
Change in the hospital anxiety and depression scale (HADS)At baseline, 3 monthslevel of anxiety and depression measured by hospital anxiety and depression scale (HADS)
Change in the acceptance of illness (AIS)At baseline, 3 monthsacceptance of illness measured by acceptance of illness scale (AIS)
Change in 6-minute walk distanceAt baseline, 3 monthsDistance in six-minute walk test
Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWDAt baseline, 3 monthsWHO functional class assessment
Compliance with counting stepsat 3 monthsCompliance with counting steps
Change in N-Terminal Pro-B-Type Natriuretic Peptide level (NT-proBNP)At baseline, 3 monthsBlood sample to measure the concentration of N-terminal Pro-B type natriuretic peptide

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026