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

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

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)

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension; Physical Inactivity
• Intervention / Treatment: Behavioral: recommendation to increase physical activity

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).

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Borowa 14/18
    • Otwock, Borowa 14/18, Poland, 05-400
      • Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Centre, Otwock, Centre of Postgraduate Medical Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A physically inactive subgroup; Patients who walked <5,000 steps per day during the first two weeks	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
Active Comparator: A physically active subgroup; Patients who walked >5,000 steps per day during the first two weeks	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6-minute walk distance	Distance in six-minute walk test	At baseline, 3 months
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
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
Change in the acceptance of illness (AIS)	acceptance of illness measured by acceptance of illness scale (AIS)	At baseline, 3 months
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
Change in World Health Organization (WHO) functional Class recorded by investigator in conjunction with the 6MWD	WHO functional class assessment	At baseline, 3 months
Compliance with counting steps	Compliance with counting steps	at 3 months

Collaborators and Investigators

• Sponsor: Centre of Postgraduate Medical Education

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): July 17, 2022

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; education; self-monitoring; pulmonary arterial hypertension; step count
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• Other Study ID Numbers: 62/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No