The Effect of Slow-Paced Breathing on Patient Outcomes in Pulmonary Arterial Hypertension

NCT07232368 | Completed DMC

• 1 other identifier: 22-AKD-202
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effects of slow-paced breathing (SPB) intervention applied to patients with pulmonary arterial hypertension (PAH) in the home environment on symptom management (dyspnea, fatigue, sleep quality), clinical parameters (Six-Minute Walking Test-6MWT), IL-6, NT-proBNP results) and quality of life.

Conditions

Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Keywords

Pulmonary Arterial Hypertension; Slow-paced Breathing; Symptom Management; Quality of life; Nursing

Outcome Measures

Primary Outcomes (6)

• Multidimensional Dyspnea Profile

  The multidimensional dyspnea profile consists of subheadings assessing immediate perception (6 items; total score range 0-60) and emotional reactions (5 items; total score range 0-50). Items are rated on a 0-10 scale, with higher scores indicating greater intensity, unpleasantness, or distress.

  Baseline, at the end of six weeks and at the end of twelve weeks

• Multidimensional Fatigue Inventory

  The inventory contains five subscales measuring general fatigue (items 1, 5, 12, and 16), physical fatigue (items 2, 8, 14, and 20), decreased activity (items 3, 6, 10, and 17), decreased motivation (items 4, 9, 15, and 18), and mental fatigue (items 7, 11, 13, and 19), totaling 20 items.

  Baseline, at the end of six weeks and at the end of twelve weeks

• Pittsburgh Sleep Quality Index

  The index is a self-report measure that provides a quantitative measure of sleep quality to describe good and poor sleep over a one-month period. It consists of seven subcomponents and 24 items, 19 of which are self-reported and five of which are self-reported or evaluated by a roommate, if present.

  Baseline, at the end of six weeks and at the end of twelve weeks

• Six-Minute Walk Test Form and Modified Borg Scale

  The 6MWT (Six-Minute Walk Test), the most commonly used exercise test in monitoring patients with pulmonary hypertension, is an easy-to-administer and inexpensive test. Walking speed should be determined by the patient, but the goal of the test is to walk as far as possible in six minutes. The Modified Borg Scale, a unidimensional scale, is a subjective, reliable, and easily administered tool for determining the severity of dyspnea and fatigue perceived by the patient at rest and during exertion. The scale identifies the severity of dyspnea/fatigue by rating (0 to 10), with a score of 0 indicating "absent" and a score of 10 indicating "maximum" dyspnea/fatigue.

  Baseline, and at the end of twelve weeks

• Laboratory Analysis Form

  It is recommended to monitor certain variables (NT-proBNP) at regular intervals during the diagnosis and follow-up phases of the disease. These variables can be used to assess prognosis and risk stratify, while also guiding the treatment protocol. In addition, some studies have used IL-6 as an indicator of inflammation and correlated it with sleep quality.

  Baseline, and at the end of twelve weeks

• EmPHasis-10 Quality of Life Scale

  This 10-question scale, developed for patients with pulmonary hypertension, addresses concerns about the disease's significant effects, such as shortness of breath, fatigue, and lack of energy, as well as its impact on social relationships. Each question on the scale has a score between 0 and 5 and is assessed using a Likert scale.

  Baseline, at the end of six weeks and at the end of twelve weeks

Study Arms (2)

control group

NO INTERVENTION

Data collection tools were applied to individuals in the control group at week 0 (first follow-up), week 6 (interim follow-up) and week 12 (final follow-up) of the follow-up period. The data collection tools administered to the control group were: Patient Identification Form, Multidimensional Dyspnea Profile, Multidimensional Fatigue Inventory, Pittsburgh Sleep Quality Index, Six-Minute Walk Test Form and Modified Borg Scale, Laboratory Analysis Form, and EmPHasis-10 Quality of Life Scale, Digital Literacy Scale-Technical Subscale.

initiative group

EXPERIMENTAL

Data collection tools were administered to individuals in the intervention group at week 0 (initial follow-up), week 6 (interim follow-up), and week 12 (final follow-up). Data collection tools administered to the intervention group included: Patient Identification Form, Multidimensional Dyspnea Profile, Multidimensional Fatigue Inventory, Pitsburgh Sleep Quality Index, Six-Minute Walk Test Form and Modified Borg Scale, Laboratory Analysis Form, EmPHasis-10 Quality of Life Scale, Digital Literacy Scale-Technical Subscale.

Other: Slow-paced breathing intervention

Interventions

Slow-paced breathing intervention OTHER

Other: Slow-paced breathing intervention After the intervention and control groups were determined, the purpose of the study was explained to both groups. Participants were informed that the intervention would last 12 weeks. Data collection forms would be completed face-to-face before the intervention (initial follow-up), during the 6th week (interim follow-up), and at the 12th week (final follow-up). Patients in the intervention group received a slow-paced breathing intervention in addition to the standard treatment protocol (verbal, video, and hands-on instruction, demonstration). After the first interview, participants received the application video (installed on a device such as a mobile phone, personal computer, and/or tablet, depending on the participant's preference and ease of use). The control group received only the standard treatment protocol. However, they were informed that they could perform the slow-paced breathing intervention upon completion of the study if they wished

initiative group

Eligibility Criteria

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

You may qualify if:

• Being between 18 and 65 years of age
• Being diagnosed with PAH (pulmonary arterial hypertension)- (Group I pulmonary hypertension (idiopathic, hereditary, drug or toxin-induced, or associated with connective tissue disease, congenital heart disease, or HIV-associated)) diagnosed by right heart catheterization
• Being on stable PAH treatment for the past three months and in a stable clinical condition (no changes in PAH medical treatment, no new medications added)
• Being in class II or III according to the World Health Organization functional classification
• Being able to speak Turkish
• Having a high level of technical digital literacy (obtaining the highest score (30 points) on the "technical subscale" of the Digital Literacy Scale\*)
• Agreeing to participate in the study

You may not qualify if:

• Communication difficulties
• Symptomatic hypotension
• Pregnancy status for female participants (positive urine pregnancy test\*)
• Presence of another underlying condition that may cause dyspnea, fatigue, and sleep difficulties (chronic fatigue syndrome, obstructive sleep apnea, restless legs syndrome, narcolepsy, major depression, etc.)
• Hospitalization or acute phase
• Active participation in a cardiac rehabilitation program
• Presence of pulmonary hypertension due to left heart disease and pulmonary hypertension due to lung diseases and/or hypoxia
• Receiving a lung transplant
• Having had cardiac surgery within the last six months
• Presence of obesity
• Presence of mental retardation

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege Üniversitesi

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In this randomized controlled experimental study, Excel random numbers function was used as the randomization method.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: It consists of two groups, application and control

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 18, 2025
• Study Start: June 11, 2023
• Primary Completion: September 15, 2023
• Study Completion: March 15, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)