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Completed

NCT Number: NCT06312111

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

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)

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Key information

Conditions

Pulmonary Arterial Hypertension Behavior Hypertension, Pulmonary Lung Diseases Motor Activity Physical Inactivity Respiratory Tract Diseases Sedentary Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Centre, Otwock, Centre of Postgraduate Medical Education

Otwock, Borowa 14/18, 05-400, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recommendation to increase physical activity

Behavioral

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

Primary outcomes

  1. Number of steps per day

    Time frame: At baseline, after initial period 2 weeks

    Number of steps per day monitored by pedometer Omron HJ-321-E

Secondary outcomes

  1. Change in 6-minute walk distance

    Time frame: At baseline, 3 months

    Distance in six-minute walk test

  2. Change in quality of life (SF-36)

    Time frame: At baseline, 3 months

    Change in quality of life recorded by patient questionnaire 36-Item Short Form Health Survey (SF-36)

  3. Change in the hospital anxiety and depression scale (HADS)

    Time frame: At baseline, 3 months

    level of anxiety and depression measured by hospital anxiety and depression scale (HADS)

  4. Change in the acceptance of illness (AIS)

    Time frame: At baseline, 3 months

    acceptance of illness measured by acceptance of illness scale (AIS)

  5. Change in N-Terminal Pro-B-Type Natriuretic Peptide level (NT-proBNP)

    Time frame: At baseline, 3 months

    Blood sample to measure the concentration of N-terminal Pro-B type natriuretic peptide

  6. Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD

    Time frame: At baseline, 3 months

    WHO functional class assessment

  7. Compliance with counting steps

    Time frame: at 3 months

    Compliance with counting steps

Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Registry information

Official study title

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

Acronym: PhA-PAH

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 15, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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