Promoting Emotional and Autonomic Control Through Guided Breathing Exercises for Emerging Adults With Autism
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Guided breathing exercise - SPB, Guided breathing exercise - HRV-BF.
- Кому может быть актуально
- Состояния в реестре: Autism, Autism Spectrum Disorder. Базовые параметры: 16 лет — 25 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study examines the impact of guided breathing exercises on stress and heart rate variability (HRV) in autistic young adults. It explores how daily movement behavior (sleep, physical activity and sedentary behavior) influences HRV and to what extent two guided breathing exercises can affect HRV. Additionally, the study investigates how participants perceive the exercises in terms of usability and usefulness.
Подробное описание
For many autistic individuals, transitioning into adulthood can be challenging and stressful. This stress often affects their mental health. The autistic community has highlighted the need for better mental health support, including accessible and effective ways to manage stress. Among the non-pharmacological interventions aimed at improving mental health via stress reduction, guided breathing interventions are promising, also on a psychophysiological level. During a stressful situation, internal regulatory processes take place to maintain balance, starting by activating the autonomic nervous system (ANS). Prior work indicates that a dysfunction of the ANS contributes to the heightened mental health challenges observed in autistic individuals. Heart rate variability (HRV), the variation in time between heartbeats, is an physiological index of the functioning of the ANS. The Neurovisceral Integration Theory highlights the role of parasympathetic regulation of the heart rate, associating higher vagally mediated HRV with better health, emotional regulation and executive functioning.In autistic individuals, the overall levels of cardiac vagal modulation are lower compared to neurotypical peers.
To date, research investigating the potential of interventions aimed at increasing HRV in autistic individuals is scarce. Moreover, HRV is influenced by several aspects (e.g., sleep, physical activity) and knowledge on their combined impact is necessary to understand how HRV can be used in research and clinical practice. Therefore, in this project, the investigators will explore the role of physical activity, sedentary behavior, and sleep on HRV and determine what constitutes a significant change in HRV.
The investigators will also examine the psychophysiological effects, feasibility, and acceptability of the two leading protocols in guided breathing interventions (heart rate variability biofeedback and slow-paced breathing). HRV-BF optimizes HRV by guiding individuals to breathe at their resonance frequency, synchronizing heart rate and breathing. SPB prescribes to breathe at a fixed pace of 6 breaths per minute.
Вмешательства
- Устройство Guided breathing exercise - SPB
Guided breathing exercises are performed at a fixed pace of 6 breaths per minute (SPB) . - Устройство Guided breathing exercise - HRV-BF
Guided breathing exercises are performed at each participant's individually determined resonance frequency, which typically falls between 4.5 and 7 breaths per minute (HRV-BF).
Первичные конечные точки
- Change in cardiac vagal modulation of heart rate based on resting-state HRV. [Срок оценки: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)]
- Change in cardiac vagal modulation of heart rate based on resting-state HRV [Срок оценки: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)]
Вторичные конечные точки (10)
- Change in mental health indicators [Срок оценки: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)]
- Change in mental health indicators [Срок оценки: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)]
- Change in mental health indicators [Срок оценки: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)]
- feasibility and acceptability of the HRV-BF and SPB interventions. [Срок оценки: For 5 weeks 4 times per day (before and after each sessions) during the intervention phase (between week 5 and week 10)]
- feasibility and acceptability of the HRV-BF and SPB interventions. [Срок оценки: For 5 weeks 4 times per day during the intervention phase (between week 5 and week 10)]
- feasibility and acceptability of the HRV-BF and SPB interventions. [Срок оценки: During the intervention phase (between week 5 and week 10) and during the once per week guided intervention sessions at week 5, 6 and 7.]
- feasibility and acceptability of the HRV-BF and SPB interventions. [Срок оценки: During the guided intervention sessions at week 5, 6 and 7.]
- feasibility and acceptability of the HRV-BF and SPB interventions. [Срок оценки: During the intervention phase (between week 5 and week 10) and during the once per week guided intervention sessions at week 5, 6 and 7.]
- feasibility and acceptability of the HRV-BF and SPB interventions. [Срок оценки: At time point 3 (week 15) during the follow-up assessment]
- Feasibility and acceptability of the HRV-BF and SPB interventions. [Срок оценки: At time point 3 (week 15) during the follow-up assessment]
Критерии участия
Критерии включения
- For participants ≥18 years a voluntary written informed consent and for participants < 18 years a written informed consent from the parents or their legally authorized representative and an informed assent of the participant has been obtained prior to any screening procedures
- Male or Female (biological)
- Between 16 and 25 years old
- Diagnosis of autism as described in the DSM-IV/DSM-5(-TR)
Критерии исключения
- Participant has a history of congenital heart diseases, diagnosed cardiovascular abnormalities or somatic diseases conditions that may interfere with the main outcome measure HRV or with the safe practice of breathing exercises (e.g., uncontrolled epilepsy, severe respiratory illness)
- Presence of contra-indications for participating (intervention and/or assessment): acute agitation and/or severe psychiatric symptoms (psychosis, mania or major depression) and/or active substance use.
- The presence of an intellectual disability, defined as an intelligence quotient < 70, as described in the DSM-IV/DSM-V.
- Insufficient knowledge of Dutch language in order to follow instructions and fill out questionnaires.
- Female who is pregnant.
- Participation in another interventional study, with or without an investigational medicinal product (IMP) or device (IMD).
- The use of medication known to affect cardiac modulation (excluding hormonal contraceptives).
- Hearing- or vision impairment that cannot be corrected to normal functioning.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Бельгия · 2 центра
- KU Leuven — Leuven
- UPC Z.Org — Leuven
Идентификаторы
NCT: NCT07238153 · S70725