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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06312111
Other study ID # 62/2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 22, 2021
Est. completion date July 17, 2022

Study information

Verified date March 2024
Source Centre of Postgraduate Medical Education
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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).


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date July 17, 2022
Est. primary completion date July 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
recommendation 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

Locations

Country Name City State
Poland Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Centre, Otwock, Centre of Postgraduate Medical Education Otwock Borowa 14/18

Sponsors (1)

Lead Sponsor Collaborator
Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of steps per day Number of steps per day monitored by pedometer Omron HJ-321-E At baseline, after initial period 2 weeks
Secondary Change in 6-minute walk distance Distance in six-minute walk test At baseline, 3 months
Secondary Change in quality of life (SF-36) Change in quality of life recorded by patient questionnaire 36-Item Short Form Health Survey (SF-36) At baseline, 3 months
Secondary Change in the hospital anxiety and depression scale (HADS) level of anxiety and depression measured by hospital anxiety and depression scale (HADS) At baseline, 3 months
Secondary Change in the acceptance of illness (AIS) acceptance of illness measured by acceptance of illness scale (AIS) At baseline, 3 months
Secondary Change in N-Terminal Pro-B-Type Natriuretic Peptide level (NT-proBNP) Blood sample to measure the concentration of N-terminal Pro-B type natriuretic peptide At baseline, 3 months
Secondary Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD WHO functional class assessment At baseline, 3 months
Secondary Compliance with counting steps Compliance with counting steps at 3 months
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