- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hui-Wen Hsu, M.S.
- Número de teléfono: 23426 +886-2-8512-8888
- Correo electrónico: 76wwocat@gmail.com
Ubicaciones de estudio
-
-
New Taipei City
-
New Taipei City, New Taipei City, Taiwán, 24352
- Fu Jen Catholic University Hospital
-
Contacto:
- Hui-Wen Hsu, M.S.
- Número de teléfono: 23426 +886-2-8512-8888
- Correo electrónico: 76wwocat@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
|
|
Comparador activo: 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.
Otros nombres:
|
|
Comparador activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in 6-Minute Walk Distance
Periodo de tiempo: Baseline and 12 weeks
|
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
|
|
Change in Timed Up and Go Test
Periodo de tiempo: Baseline and 12 weeks
|
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
|
|
Change in Stair Climbing Performance
Periodo de tiempo: Baseline and 12 weeks
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in St. George's Respiratory Questionnaire Score
Periodo de tiempo: Baseline and after 12 weeks of formal training
|
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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hui-Wen Hsu, M.S., Fu Jen Catholic University Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FJUH115600
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .