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

NCT06312111 | Completed

• 1 other identifier: 62/2021
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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)

Conditions

Pulmonary Arterial Hypertension; Physical Inactivity

Keywords

pulmonary arterial hypertension; education; self-monitoring; physical activity; step count

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in 6-minute walk distance

  At baseline, 3 months

• Change in quality of life (SF-36)

  At baseline, 3 months

• Change in the hospital anxiety and depression scale (HADS)

  At baseline, 3 months

• Change in the acceptance of illness (AIS)

  At baseline, 3 months

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

  At baseline, 3 months

Study Arms (2)

A physically inactive subgroup

EXPERIMENTAL

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

Behavioral: recommendation to increase physical activity

A physically active subgroup

ACTIVE COMPARATOR

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

Behavioral: recommendation to increase physical activity

Interventions

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

A physically active subgroup; A physically inactive subgroup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age equal to or greater than 18 years
• PAH diagnosis according to current guidelines, confirmed by right heart catheterization
• optimal pharmacological treatment
• Informed consent to participate in your own

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: April 22, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 17, 2022
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)