- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07867535
High-Intensity Interval Alternating Concentric-Eccentric Training in Chronic Respiratory Disease (Effects of Hig)
Effects of High-Intensity Interval Alternating Concentric-Eccentric Training on Functional Performance in Patients With Chronic Respiratory Disease: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of high-intensity interval training incorporating alternating concentric and eccentric cycling on functional performance in adults with chronic respiratory disease undergoing pulmonary rehabilitation. A total of 45 participants will be randomly assigned to one of three groups: high-intensity interval alternating concentric-eccentric training, high-intensity interval concentric training, or usual care. Participants in the exercise training groups will complete a 12-week supervised exercise program, while the usual-care group will continue routine care with self-regulated exercise intensity. Functional performance, exercise capacity, and patient-reported outcomes will be assessed before and after the intervention. The study seeks to determine whether incorporating eccentric exercise into high-intensity interval training can improve physical function while reducing cardiopulmonary and perceived exercise burden.
Przegląd badań
Status
Szczegółowy opis
Chronic respiratory diseases, particularly chronic obstructive pulmonary disease (COPD), are commonly associated with exercise intolerance, dyspnea, peripheral muscle dysfunction, and reduced quality of life. Although exercise training is a central component of pulmonary rehabilitation, patients may have difficulty tolerating conventional high-intensity exercise because of ventilatory limitation and leg fatigue.
Eccentric exercise can generate relatively high mechanical workloads with lower oxygen consumption and cardiopulmonary demand than concentric exercise. High-intensity interval training (HIIT), on the other hand, is an effective approach for improving aerobic capacity. This study therefore investigates whether incorporating eccentric cycling into the recovery periods of HIIT can provide additional skeletal muscle stimulation without substantially increasing cardiopulmonary stress.
This is a single-center, prospective, randomized controlled trial conducted at Fu Jen Catholic University Hospital. Forty-five adults with chronic respiratory disease who have participated in pulmonary rehabilitation for more than 3 months will be enrolled and randomly allocated to three groups, with approximately 15 participants in each group: (1) high-intensity interval alternating concentric-eccentric training, (2) high-intensity interval concentric training, or (3) usual care.
Before randomization, participants will undergo graded exercise testing, functional performance assessments, and questionnaires. Participants assigned to the exercise groups will complete supervised training for 12 weeks. The alternating concentric-eccentric group will also undergo an eccentric exercise familiarization period before the formal training program. Participants in the usual-care group will continue routine care with self-regulated exercise intensity for 12 weeks. After the intervention, graded exercise testing, functional assessments, and questionnaires will be repeated.
The study will evaluate changes in functional performance, exercise capacity, muscle function, symptoms, and quality of life to determine whether alternating concentric-eccentric HIIT provides additional benefits compared with conventional concentric HIIT and usual care.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Hui-Wen Hsu, M.S.
- Numer telefonu: 23426 +886-2-8512-8888
- E-mail: 76wwocat@gmail.com
Lokalizacje studiów
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New Taipei City
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New Taipei City, New Taipei City, Tajwan, 24352
- Fu Jen Catholic University Hospital
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Kontakt:
- Hui-Wen Hsu, M.S.
- Numer telefonu: 23426 +886-2-8512-8888
- E-mail: 76wwocat@gmail.com
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Able and willing to provide written informed consent. Adults aged 18 years or older with chronic respiratory disease. Have participated in a pulmonary rehabilitation program for more than 3 months. For participants with an implanted cardioverter-defibrillator (ICD), the programmed maximum heart rate must be higher than the target heart rate used during exercise training.
Considered medically suitable for exercise training by a specialist physician.
Exclusion Criteria:
- Presence of a tracheostomy. Use of long-term home oxygen therapy or home mechanical ventilation. Severe left-sided heart failure classified as New York Heart Association (NYHA) functional class III or IV.
Diagnosis of a neuromuscular disease. Acute exacerbation of chronic obstructive pulmonary disease (COPD) within the previous 3 months.
Unable to complete or cooperate with cardiopulmonary exercise testing.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Alternating Concentric-Eccentric HIIT
Participants will undergo a 2-week eccentric cycling familiarization period followed by 12 weeks of high-intensity interval training. During the high-intensity intervals, concentric cycling will be performed at 80% of peak work rate, while the recovery intervals will use eccentric cycling at the same external workload. |
Participants will complete a 2-week eccentric cycling familiarization period followed by 12 weeks of supervised high-intensity interval training, performed twice weekly. Each formal training session lasts approximately 40 minutes and includes a 5-minute warm-up at 30% of peak work rate (Wpeak), 30 minutes of interval training, and a 5-minute cool-down at 30% Wpeak. The interval phase consists of five cycles of 2 minutes of concentric cycling at 80% Wpeak followed by 4 minutes of eccentric cycling performed at the same external workload as the high-intensity concentric interval.
Inne nazwy:
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Aktywny komparator: Concentric HIIT
Participants will undergo 12 weeks of high-intensity interval concentric cycling training. High-intensity intervals will be performed at 80% of peak work rate, with recovery intervals performed concentrically at 40% of peak work rate. |
Participants will complete 12 weeks of supervised high-intensity interval concentric cycling training, performed twice weekly. Each session lasts approximately 40 minutes and includes a 5-minute warm-up at 30% of peak work rate (Wpeak), 30 minutes of interval training, and a 5-minute cool-down at 30% Wpeak. The interval phase consists of five cycles of 2 minutes of concentric cycling at 80% Wpeak followed by 4 minutes of concentric cycling at 40% Wpeak.
Inne nazwy:
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Aktywny komparator: Usual Care
Participants will continue usual care with self-regulated exercise intensity for 12 weeks. |
Participants will continue usual care with self-regulated exercise intensity for 12 weeks. No structured high-intensity interval or eccentric cycling training will be provided as part of the study intervention. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in 6-Minute Walk Distance
Ramy czasowe: Baseline and 12 weeks
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The 6-minute walk test will be used to assess functional exercise capacity. The distance walked in 6 minutes on a 30-meter indoor corridor will be recorded in meters. Change from baseline to post-intervention will be compared among the three study groups. |
Baseline and 12 weeks
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Change in Timed Up and Go Test
Ramy czasowe: Baseline and 12 weeks
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The Timed Up and Go test will be used to assess functional mobility, balance, and gait performance. Participants will stand from a chair, walk 3 meters, turn, return to the chair, and sit down. Three trials will be performed, and the fastest completion time in seconds will be used for analysis. |
Baseline and 12 weeks
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Change in Stair Climbing Performance
Ramy czasowe: Baseline and 12 weeks
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Stair climbing performance will be assessed using a fixed number of stairs to evaluate lower-extremity strength, balance, agility, and functional performance. Completion time will be recorded in seconds. |
Baseline and 12 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in St. George's Respiratory Questionnaire Score
Ramy czasowe: Baseline and after 12 weeks of formal training
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Health-related quality of life will be assessed using the St. George's Respiratory Questionnaire (SGRQ). Changes in total score from baseline to post-intervention will be evaluated. |
Baseline and after 12 weeks of formal training
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Hui-Wen Hsu, M.S., Fu Jen Catholic University Hospital
Publikacje i pomocne linki
Publikacje ogólne
- Milanovic Z, Sporis G, Weston M. Effectiveness of High-Intensity Interval Training (HIT) and Continuous Endurance Training for VO2max Improvements: A Systematic Review and Meta-Analysis of Controlled Trials. Sports Med. 2015 Oct;45(10):1469-81. doi: 10.1007/s40279-015-0365-0.
- Inostroza M, Valdes O, Tapia G, Nunez O, Kompen MJ, Nosaka K, Penailillo L. Effects of eccentric vs concentric cycling training on patients with moderate COPD. Eur J Appl Physiol. 2022 Feb;122(2):489-502. doi: 10.1007/s00421-021-04850-x. Epub 2021 Nov 20.
- Chao KY, Liu WL, Hsu HW, Chen HC, Lim AY, Wang JS. Eccentric cycling for chronic respiratory disease: Does helmet ventilation add value? A randomized controlled trial. Chron Respir Dis. 2025 Jan-Dec;22:14799731251404870. doi: 10.1177/14799731251404870. Epub 2025 Nov 25.
- Harrison AJ, Burdon CA, Groeller H, Peoples GE. The Acute Physiological Responses of Eccentric Cycling During the Recovery Periods of a High Intensity Concentric Cycling Interval Session. Front Physiol. 2020 Apr 17;11:336. doi: 10.3389/fphys.2020.00336. eCollection 2020.
- Pancera S, Lopomo NF, Porta R, Sanniti A, Buraschi R, Bianchi LNC. Effects of Combined Endurance and Resistance Eccentric Training on Muscle Function and Functional Performance in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Mar;105(3):470-479. doi: 10.1016/j.apmr.2023.09.004. Epub 2023 Sep 15.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FJUH115600
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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