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

NCT ID: NCT06312111

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2022-07-17

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).

Conditions

Pulmonary Arterial Hypertension; Physical Inactivity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A physically inactive subgroup

Patients who walked \<5,000 steps per day during the first two weeks

Group Type: EXPERIMENTAL

recommendation to increase physical activity

Intervention Type: 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

A physically active subgroup

Patients who walked \>5,000 steps per day during the first two weeks

Group Type: ACTIVE_COMPARATOR

recommendation to increase physical activity

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre of Postgraduate Medical Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Otwock, Borowa 14/18, Poland

Countries

Poland

Other Identifiers

62/2021

Identifier Type: -

Identifier Source: org_study_id