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

Pulmonary Arterial Hypertension Clinical Trial

— PhA-PAH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06312111
• Other study ID #: 62/2021
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Physical Inactivity
• Pulmonary Arterial Hypertension

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