- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07728578
Effect of Pilates Training Versus High Intensity Interval Training on Cardiorespiratory Fitness in Asthmatic Patients
22. července 2026 aktualizováno: Ghidaa Elmahdi Eldomiaty, Horus University
To compare the effect of Pilates Training Versus High Intensity Interval Training on Cardiorespiratory Fitness in Asthmatic Patients.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Detailní popis
Asthma is a widespread chronic inflammatory disease affecting over 300 million people globally, leading to approximately 461,000 deaths annually.
Exercise, particularly Pilates and high-intensity interval training, is critical for improving cardiorespiratory fitness and can enhance the quality of life for asthma patients, who often face reduced physical fitness and comorbidities like depression.
Pilates improves respiratory control and strengthens respiratory muscles, while high-intensity interval training enhances aerobic and anaerobic capacities, reduces inflammation, and improves maximal oxygen uptake (VO₂ max).
This study aims to establish guidelines comparing the effects of Pilates and high-intensity interval training on cardiorespiratory fitness in asthmatic patients.
Typ studie
Intervenční
Zápis (Odhadovaný)
51
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Ghidaa Elmahdi Eldomiaty, Assistant lecturer
- Telefonní číslo: +20 10 22143737
- E-mail: gelmahdi@horus.edu.eg
Studijní místa
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Damietta, Egypt
- out-patient clinic, faculty of physical therapy, Horus university
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Kontakt:
- Ghidaa Elmahdi Eldomiaty, Assistant lecturer
- Telefonní číslo: +20 10 22143737
- E-mail: gelmahdi@horus.edu.eg
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- 51 patients diagnosed with a clinical diagnosis of asthma and a history of respiratory illness, aged between 30 and 40 years.
- Medically stable and capable of performing physical exercise.
- All participants provided written informed consent before enrollment.
- body mass index 25.0 - 29.9 (overweight)
- Patients with partially controlled asthma according to the Asthma Control Questionnaire (ACQ) from 0 to 1.5.
Exclusion Criteria:
- Participants with musculoskeletal limitations, cardiovascular instability, or any contraindications to exercise were excluded.
- Uncontrolled hypertension.
- Cognitive impaired patients.
- Severe Anemic patients.
- Pregnancy.
- Recent cardiothoracic surgery.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Pilates exercises
Patients will receive Pilates exercises administered to Group A include five movements: The Hundred, Single Leg Stretch, Side Kick, Toe Taps, and Leg Pull Front all performed with structured breathing patterns to emphasize respiratory control and core stabilization.
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17 Patients will perform Pilates exercises 40-60 mins, three times per week, over 8weeks. Pilates exercises include five movements: The Hundred, Single Leg Stretch, Side Kick, Toe Taps, and Leg Pull Front, all performed with structured breathing Patterns To Emphasize Respiratory Control And Core Stabilization
Breathing in slowly and deeply through the nose using the diaphragm with a minimum movement of the chest in a supine position with one hand placed on the chest and the other on the belly.
During breathing, practitioners should be careful that chest remains as still as possible and stomach moves against the hand focusing on contracting the diaphragm.
Generally, diaphragmatic breathing practitioners inhale and exhale for approximately six seconds, respectively
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Experimentální: low-volume high-intensity interval training
Patients will receive low-volume high-intensity interval training.
Participants will perform 3-minute High Intensity Interval Training intervals on a treadmill at 85- 90% of heart rate reserve, each followed by 2 minutes of moderate-intensity active recovery at 60% -70% of eart rate reserve.
The total time spent in the exercise session is 25-30 minutes.
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Breathing in slowly and deeply through the nose using the diaphragm with a minimum movement of the chest in a supine position with one hand placed on the chest and the other on the belly.
During breathing, practitioners should be careful that chest remains as still as possible and stomach moves against the hand focusing on contracting the diaphragm.
Generally, diaphragmatic breathing practitioners inhale and exhale for approximately six seconds, respectively
17 patients will engage in low-volume high-intensity interval training complemented by diaphragmatic breathing exercises.
Each session begins with a 5-10 minute warm-up on a treadmill at 40% of heart rate reserve.
The targeted heart rate during high-intensity interval training is set at 85-90% of heart rate reserve plus resting heart rate.
Participants will complete 3-minute high-intensity interval training intervals at the specified intensity, alternating with 2 minutes of moderate-intensity recovery at 60-70% heart rate reserve.
Total exercise duration is 25-30 minutes, concluding with a 5-minute cool-down at 30% heart rate reserve.
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Aktivní komparátor: Diaphragmatic breathing exercises
Diaphragmatic breathing exercises involve inhaling slowly through the nose while keeping the chest still and allowing the diaphragm to move the stomach.
This is performed in a supine position, with one hand on the chest and the other on the belly, ensuring minimal chest movement.
Practitioners typically inhale and exhale over six seconds each.
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Breathing in slowly and deeply through the nose using the diaphragm with a minimum movement of the chest in a supine position with one hand placed on the chest and the other on the belly.
During breathing, practitioners should be careful that chest remains as still as possible and stomach moves against the hand focusing on contracting the diaphragm.
Generally, diaphragmatic breathing practitioners inhale and exhale for approximately six seconds, respectively
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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assessment of maximum oxygen consumption
Časové okno: At baseline and after 8 weeks
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Cardiopulmonary exercise testing is essential for evaluating patient symptoms, disease severity, prognosis, and therapy responses.
It assesses the interaction of cardiovascular and pulmonary systems with other bodily systems.
maximum oxygen consumption is calculated using the Bruce protocol via the Ergo Spiro Device.
This protocol involves a multi-stage treadmill test, starting at a 10% grade and increasing speed and grade every three minutes until exhaustion.
Subjects must refrain from eating, smoking, and consuming caffeine before testing, and avoid intense exercise leading up to the test.
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At baseline and after 8 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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assessment of Quality of Life
Časové okno: At baseline and after 8 weeks
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The Mini-Asthma Quality of Life Questionnaire is a shortened, 15-item version of the original questionnaire, designed to accurately assess the quality of life in asthmatic patients without consuming much time.
It evaluates four domains: symptoms, activity limitation, emotional function, and environmental stimuli, based on the respondents' experiences over the past two weeks.
it employs a 7-point Likert scale, where 7 indicates no impairment and 1 signifies significant impairment
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At baseline and after 8 weeks
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assessment of dyspnea
Časové okno: At baseline and after 8 weeks
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The Modified Borg Dyspnea Scale is a validated, numerical rating scale used to quantify the subjective perception of breathlessness during physical activity or exercise.
The scale ranges from 0 to 10, where 0 indicates no breathlessness and 10 represents maximal or extremely severe breathlessness.
Participants are instructed to rate their perceived level of dyspnea immediately after or during exercise, providing a simple, reliable, and clinically applicable measure of symptom intensity for monitoring exercise tolerance and evaluating treatment outcomes.
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At baseline and after 8 weeks
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assessment of asthma symptoms
Časové okno: At baseline and after 8 weeks
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Asthma Control Questionnaire (ACQ-6) is a six-item questionnaire designed to measure asthma symptoms.
The questionnaire is scored by the mean of all items (0-6), with higher scores indicating poorer control.
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At baseline and after 8 weeks
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
25. července 2026
Primární dokončení (Odhadovaný)
1. listopadu 2026
Dokončení studie (Odhadovaný)
30. listopadu 2026
Termíny zápisu do studia
První předloženo
22. července 2026
První předloženo, které splnilo kritéria kontroly kvality
22. července 2026
První zveřejněno (Aktuální)
27. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
27. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Ghidaa-PHD
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