CompletedNot Applicable

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

Turkey (Türkiye)42 participantsStarted 2023-06-11

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 obesit…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Multidimensional Dyspnea Profile

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

Multidimensional Fatigue Inventory

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

Pittsburgh Sleep Quality Index

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

Six-Minute Walk Test Form and Modified Borg Scale

Timeframe: Baseline, and at the end of twelve weeks

Laboratory Analysis Form

Timeframe: Baseline, and at the end of twelve weeks

EmPHasis-10 Quality of Life Scale

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

Trial details

NCT IDNCT07232368

SponsorEge University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-15

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Multidimensional Dyspnea Profile

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

Multidimensional Fatigue Inventory

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

Pittsburgh Sleep Quality Index

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

Six-Minute Walk Test Form and Modified Borg Scale

Timeframe: Baseline, and at the end of twelve weeks

Laboratory Analysis Form

Timeframe: Baseline, and at the end of twelve weeks

EmPHasis-10 Quality of Life Scale

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