- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07930221
The Effects of Yoga Practice on Exercise Capacity, Arterial Stiffness, Respiratory Function, Peripheral Muscle Strength, Posture and Quality of Life in Children With Cystic Fibrosis
The aim of this study is to investigate the effects of exercise training applied through telerehabilitation on exercise capacity, peripheral and respiratory muscle strength, arterial stiffness, posture and quality of life in children with cystic fibrosis.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The most common problems in patients with cystic fibrosis (CF) are increased bronchial secretions, reduced exercise tolerance and shortness of breath.
Exercise capacity is limited due to muscle dysfunction, inflammation and progressive respiratory disease. Cardiovascular complications are one of the long-term complications of CF. Increased arterial stiffness is an indicator of elevated cardiovascular risk. It has been shown that patients with CF have increased arterial stiffness compared to their healthy peers.
Exercise training has a positive effect on exercise capacity, respiratory function and quality of life in patients with CF. Studies have shown that exercise training applied using the telerehabilitation method increases exercise capacity and improves peripheral muscle function in patients with CF. Peripheral muscle function, functional capacity, arterial stiffness and posture have been assessed in patients with CF. Furthermore, studies have been performed on patients with CF involving exercise training via telerehabilitation.In addition, various studies have shown that yoga and aerobic exercise training have positive effects on arterial stiffness. Although there are only a few studies involving patients with CF who practise yoga, no study has been found that assesses the effects of yoga practise via telerehabilitation on exercise capacity, peripheral and respiratory muscle function, and arterial stiffness.The purpose of this study is to examine the effects of exercise training using telerehabilitation on exercise capacity, peripheral and respiratory muscle strength, arterial stiffness, posture and quality of life in children with CF.
Children were randomly assigned to three groups: The first group will receive online aerobic exercise training and yoga sessions. The second group will receive only aerobic exercise training.The third group will be informed about the importance of physical activity and will be given recommendations for physical activity. Participants' respiratory function, exercise capacity, arterial stiffness parameters, peripheral muscle function, posture and quality of life questionnaire will be evaluated initially and following an 8-week exercise programme.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Naciye Vardar-Yagli, PhD
- Número de teléfono: +903123051576 ext 129
- Correo electrónico: naciyevardar@yahoo.com
Ubicaciones de estudio
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Ankara, Turquía (Türkiye), 06100
- Reclutamiento
- Hacettepe University
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Contacto:
- Naciye Vardar-Yagli, PhD
- Número de teléfono: +903123051576
- Correo electrónico: naciyevardar@yahoo.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients aged 8-18 years with a diagnosis of cystic fibrosis (CF)
- Access to online exercise training
- Percent predicted of forced expiratory volume at one second (FEV1) > 40% in pulmonary function test
Exclusion Criteria:
- Being diagnosed with acute pulmonary exacerbation at the time of study and /or within the last month.
- Being physically or perceptually competent to exercise
- Patients with allergic bronchopulmonary aspergillosis who were treated with systemic steroid therapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Combined Group
aerobic exercise training and yoga sessions in patients with cystic fibrosis |
Patients will be performed online in groups of 3-4 participants supervised aerobic exercises and yoga sessions. Aerobic exercises will be applied for 8 weeks, for 30-45 minutes, at 65-75% of the maximum heart rate, 3 days a week, on the days when yoga sessions are not performed. The yoga sessions will consist of 30-40-minute sessions, with three sessions per week for eight weeks. The yoga sessions will consist of three core components - asana (postures), pranayama (breathing) and meditation (focus). |
|
Experimental: aerobic group
only aerobic exercises in patients with cystic fibrosis |
Patients will be performed online in groups of 3-4 participants supervised only aerobic exercises Aerobic exercises will be applied for 8 weeks, for 30-45 minutes, at 65-75% of the maximum heart rate, 3 days a week. |
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Experimental: control group
physical activity recommendations in patients with cystic fibrosis |
Patients will be informed of the benefits of physical activity and appropriate physical activity recommendations will be provided. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
six minute walk test
Periodo de tiempo: before the exercise training
|
the distance reached in the six-minute walk test |
before the exercise training
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|
six minute walk test
Periodo de tiempo: eigth week
|
the distance reached in the six-minute walk test |
eigth week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Arterial stiffness
Periodo de tiempo: before the exercise training
|
Arterial stiffness will be assessed non-invasively using the Mobil-O-GRAPH (I.E.M., Stolberg, Germany). |
before the exercise training
|
|
Arterial stiffness
Periodo de tiempo: eight week
|
Arterial stiffness will be assessed non-invasively using the Mobil-O-GRAPH (I.E.M., Stolberg, Germany). |
eight week
|
|
Respiratory muscle strength
Periodo de tiempo: before the exercise training
|
Respiratory muscle strength will be evaluated using mouth pressure device |
before the exercise training
|
|
Respiratory muscle strength
Periodo de tiempo: eight week
|
Respiratory muscle strength will be evaluated using mouth pressure device |
eight week
|
|
respiratory muscle endurance
Periodo de tiempo: before the exercise training
|
Respiratory muscle endurance will be assessed using constant load test |
before the exercise training
|
|
respiratory muscle endurance
Periodo de tiempo: eight week
|
Respiratory muscle endurance will be assessed using constant load test |
eight week
|
|
Pulmonary functions-FVC
Periodo de tiempo: before the exercise training
|
Forced vital capacity (FVC) |
before the exercise training
|
|
Pulmonary functions-FVC
Periodo de tiempo: eight week
|
Forced vital capacity (FVC) |
eight week
|
|
Pulmonary functions-FEV1
Periodo de tiempo: before the exercise training
|
Forced expiratory volume in the first second (FEV1) |
before the exercise training
|
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Pulmonary functions-FEV1
Periodo de tiempo: eigth week
|
Forced expiratory volume in the first second (FEV1) |
eigth week
|
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Pulmonary functions-FEV1/FVC
Periodo de tiempo: before the exercise training
|
FEV1/ FVC |
before the exercise training
|
|
Pulmonary functions-FEV1/FVC
Periodo de tiempo: eight week
|
FEV1/ FVC |
eight week
|
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Pulmonary functions-FEF25-75
Periodo de tiempo: before the exercise training
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Forced mid-expiratory flow (FEF25-75) |
before the exercise training
|
|
Pulmonary functions-FEF25-75
Periodo de tiempo: eigth week
|
Forced mid-expiratory flow (FEF25-75) |
eigth week
|
|
Peripheral muscle strength
Periodo de tiempo: before the exercise training
|
Peripheral muscle strength will be assessed using dynamometer |
before the exercise training
|
|
Peripheral muscle strength
Periodo de tiempo: eigth week
|
Peripheral muscle strength will be assessed using dynamometer |
eigth week
|
|
1 minute sit to stand test (STS) repetitions
Periodo de tiempo: before the exercise training
|
number of sit to stand for one minute is recorded |
before the exercise training
|
|
1 minute sit to stand test (STS) repetitions
Periodo de tiempo: eight week
|
number of sit to stand for one minute is recorded |
eight week
|
|
posture
Periodo de tiempo: before the exercise training
|
Posture will be assessed using Corbin Postural Assessment scale. Lateral and posterior views will be assessed (0 = absent,1 = mild, 2 = moderate, 3 = severe) and posture score will be determined as excellent(0-2), very good (3-4), good (5-7), fair (8-11)and poor (>12). |
before the exercise training
|
|
posture
Periodo de tiempo: eigth week
|
Posture will be assessed using Corbin Postural Assessment scale. Lateral and posterior views will be assessed (0 = absent,1 = mild, 2 = moderate, 3 = severe) and posture score will be determined as excellent(0-2), very good (3-4), good (5-7), fair (8-11)and poor (>12). |
eigth week
|
|
Quality of life assessment
Periodo de tiempo: before the exercise training
|
Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised .The Cystic Fibrosis Questionnaire-Revised is a disease-specific health-related quality of life measure for children, adolescents with cystic fibrosis (CF). The questionnaire evaluate physical functioning, emotional functioning, social functioning, body image, eating disorders, treatment,respiratory symptoms and digestive symptoms. Score range is 0-100. Higher scores indicating higher health-related qualityof life. |
before the exercise training
|
|
Quality of life assessment
Periodo de tiempo: eigth week
|
Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised .The Cystic Fibrosis Questionnaire-Revised is a disease-specific health-related quality of life measure for children, adolescents with cystic fibrosis (CF). The questionnaire evaluate physical functioning, emotional functioning, social functioning, body image, eating disorders, treatment,respiratory symptoms and digestive symptoms. Score range is 0-100. Higher scores indicating higher health-related quality of life. |
eigth week
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Naciye Vardar-Yagli, PhD, Hacettepe University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Términos MeSH relevantes adicionales
- Enfermedades Genéticas Congénitas
- Enfermedades de las vías respiratorias
- Enfermedades del Sistema Digestivo
- Enfermedades pulmonares
- Infantil, Recién Nacido, Enfermedades
- Enfermedades pancreáticas
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Comportamiento
- Fibrosis quística
- Actividad del motor
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Terapias de la mente-cuerpo
- Terapias complementarias
- Terapias espirituales
- Técnicas de movimiento del ejercicio
- Modalidades de fisioterapia
- Ejercicio
- Yoga
Otros números de identificación del estudio
- FTREK25/92
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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