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حالة التجربة السريرية NCT07044843 لـ مرض الانسداد الرئوي المزمن هي نشط (التجنيد مغلق). اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
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Oxygen Therapy During Exercise Training in Inpatient Rehabilitation in Chronic Lung Disease- Does it Matter?

نشط (التجنيد مغلق)
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ 'رادار التجارب AI' أن يساعدك؛ ما عليك سوى النقر على 'وصف الدراسة' لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07044843 هي دراسة تدخُّلية لـمرض الانسداد الرئوي المزمن وهي نشط (التجنيد مغلق). بدأت في ٢٨ محرم ١٤٤٧ هـ مع خطة لتجنيد ٥٤ مشاركًا. يقودها Eastern Switzerland University of Applied Sciences، ومن المتوقع اكتمالها بحلول ١١ رجب ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٣ صفر ١٤٤٧ هـ.
الملخص
The aim of the current study is the effect of SSOT during a 3-weeks inpatient pulmonary rehabilitation program. Further aim is to analyze exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at approx. 1600m "hypoxia", or breathing SSOT at 760m "hyperoxia" conditions during inpatient pulmonary rehabilitation.

The objective of the study is to provide long-awaited data concerning the use of SSOT during training. To date, it is not clear whether patients with chronic lung diseases who reveal a SpO2 > 88% at rest but desaturate during exercise and thus may not qualify for long-term oxygen therapy undergoing PR benefit from supplemental oxygen.

العنوان الرسمي

Oxygen Therapy During Exercise Training in Inpatient Rehabilitation in Chronic Lung Disease- Does it Matter?

الحالات الطبية
مرض الانسداد الرئوي المزمن
معرّفات دراسة أخرى
  • inRehaExO2_normoxia_hyperoxia
NCT معرّف
NCT07044843
تاريخ البدء (فعلي)
2025-07-23
آخر تحديث مُنشور
2025-08-07
تاريخ الاكتمال (المقدر)
2025-12-31
عدد المشاركين المخطط لهم
٥٤
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
نشط (التجنيد مغلق)
الكلمات الرئيسية
Oxygen
Exercise
Rehabilitation
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
تصميم تسلسلي
التعمية
رباعي
مجموعات/التدخلات
مجموعة المشاركين/مجموعةتَدَخُّل/علاج
المقارن الزائفNormoxia
Sham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula.
Standard Ambiant Air Will Be Breathed During Endurance Training.
ambiant air
مقارن نشطHyperoxia
Standardized supplemental oxygen therapy (SSOT) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training
الأكسجين
SSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training
تجريبيةHypoxia
This group will train at moderate altitude.
Standard Ambiant Air Will Be Breathed During Endurance Training.
ambiant air
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia
from baseline to 3 weeks
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
6 minute walk test (6MWT)
6 minute walk distance (6MWD), SpO2 and heart rate at the end of the 6 minute walk test (6MWT) from baseline to 3 weeks at normoxia vs hypoxia vs hyperoxia
3 weeks
Hospital Anxiety and Depression Scale (HADS) normoxia vs hypoxia vs hyperoxia
HADS-A (Anxiety): 7 items HADS-D (Depression): 7 items Each item is scored from 0 to 3, resulting in: Minimum score per subscale: 0 Maximum score per subscale: 21 Interpretation: Higher scores indicate worse psychological status. Scores of 0-7: Normal Scores of 8-10: Borderline abnormal Scores of 11-21: Abnormal (clinically relevant anxiety or depression)
3 weeks
mMRC score at normoxia vs hypoxia vs hyperoxia
The scale ranges from 0 to 4. Each grade reflects a different level of functional limitation due to dyspnea. Minimum score: 0 Maximum score: 4 Interpretation: Higher scores indicate more severe dyspnea (worse outcome).
3 weeks
CAT score (COPD assessments tool) normoxia vs hypoxia vs hyperoxia
It consists of 8 items, each scored from 0 to 5. The total score ranges from: Minimum score: 0 Maximum score: 40 Interpretation: Higher scores indicate greater symptom burden and worse health status. Score bands for interpretation: 0-10: Low impact 11-20: Medium impact 21-30: High impact 31-40: Very high impact
3 weeks
Chronic respiratory questionnaire (CRQ) normoxia vs hypoxia vs hyperoxia
The CRQ consists of 20 items across four domains: Dyspnea (5 items) Fatigue (4 items) Emotional function (7 items) Mastery (4 items) Each item is scored on a 7-point Likert scale: Minimum score per item: 1 Maximum score per item: 7 Interpretation: Higher scores indicate better health-related quality of life (less impairment). Mean scores are calculated per domain and as a total score.
3 weeks
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia
3 months
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  • aged ≥ 18 years
  • stable condition > 3 weeks (e.g. no exacerbations)
  • resting SpO2 ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% and/or below 90% during a 6-minute walk test (6MWT)
  • informed consent as documented by signature.

  • Severe daytime resting hypoxemia (SpO2 < 88%)
  • long-term oxygen therapy
  • unstable condition requiring adaptation of pharmacologic and other treatment modalities or requirement of intensive care or relevant severe concomitant disease
  • inability to follow the procedures of the study, e.g. due to language problems psychological disorders, neurological or orthopedic problems with walking disability or inability to ride a bicycle
  • women who are pregnant or breast feeding
  • enrolment in another clinical trial with active treatment.
Eastern Switzerland University of Applied Sciences logoEastern Switzerland University of Applied Sciences
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2 مواقع الدراسة في 2 بلدان
National center for cardiology and internal medicine, Bishkek, Kyrgyzstan

Canton of St. Gallen

Eastern Switzerland University of Applied Sciences, Sankt Gallen, Canton of St. Gallen, 9001, Switzerland