- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Naciye Vardar-Yagli, PhD
- Numero di telefono: +903123051576 ext 129
- Email: naciyevardar@yahoo.com
Luoghi di studio
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Ankara, Turchia (Türkiye), 06100
- Reclutamento
- Hacettepe University
-
Contatto:
- Naciye Vardar-Yagli, PhD
- Numero di telefono: +903123051576
- Email: naciyevardar@yahoo.com
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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). |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
six minute walk test
Lasso di tempo: before the exercise training
|
the distance reached in the six-minute walk test |
before the exercise training
|
|
six minute walk test
Lasso di tempo: eigth week
|
the distance reached in the six-minute walk test |
eigth week
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Arterial stiffness
Lasso di tempo: 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
Lasso di tempo: eight week
|
Arterial stiffness will be assessed non-invasively using the Mobil-O-GRAPH (I.E.M., Stolberg, Germany). |
eight week
|
|
Respiratory muscle strength
Lasso di tempo: before the exercise training
|
Respiratory muscle strength will be evaluated using mouth pressure device |
before the exercise training
|
|
Respiratory muscle strength
Lasso di tempo: eight week
|
Respiratory muscle strength will be evaluated using mouth pressure device |
eight week
|
|
respiratory muscle endurance
Lasso di tempo: before the exercise training
|
Respiratory muscle endurance will be assessed using constant load test |
before the exercise training
|
|
respiratory muscle endurance
Lasso di tempo: eight week
|
Respiratory muscle endurance will be assessed using constant load test |
eight week
|
|
Pulmonary functions-FVC
Lasso di tempo: before the exercise training
|
Forced vital capacity (FVC) |
before the exercise training
|
|
Pulmonary functions-FVC
Lasso di tempo: eight week
|
Forced vital capacity (FVC) |
eight week
|
|
Pulmonary functions-FEV1
Lasso di tempo: before the exercise training
|
Forced expiratory volume in the first second (FEV1) |
before the exercise training
|
|
Pulmonary functions-FEV1
Lasso di tempo: eigth week
|
Forced expiratory volume in the first second (FEV1) |
eigth week
|
|
Pulmonary functions-FEV1/FVC
Lasso di tempo: before the exercise training
|
FEV1/ FVC |
before the exercise training
|
|
Pulmonary functions-FEV1/FVC
Lasso di tempo: eight week
|
FEV1/ FVC |
eight week
|
|
Pulmonary functions-FEF25-75
Lasso di tempo: before the exercise training
|
Forced mid-expiratory flow (FEF25-75) |
before the exercise training
|
|
Pulmonary functions-FEF25-75
Lasso di tempo: eigth week
|
Forced mid-expiratory flow (FEF25-75) |
eigth week
|
|
Peripheral muscle strength
Lasso di tempo: before the exercise training
|
Peripheral muscle strength will be assessed using dynamometer |
before the exercise training
|
|
Peripheral muscle strength
Lasso di tempo: eigth week
|
Peripheral muscle strength will be assessed using dynamometer |
eigth week
|
|
1 minute sit to stand test (STS) repetitions
Lasso di tempo: 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
Lasso di tempo: eight week
|
number of sit to stand for one minute is recorded |
eight week
|
|
posture
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Naciye Vardar-Yagli, PhD, Hacettepe University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie genetiche, congenite
- Malattie delle vie respiratorie
- Malattie dell'apparato digerente
- Malattie polmonari
- Infante, neonato, malattie
- Malattie pancreatiche
- Malattie e anomalie congenite, ereditarie e neonatali
- Comportamento
- Fibrosi cistica
- Attività motoria
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Terapie
- Terapie mind-body
- Terapie complementari
- Terapie spirituali
- Tecniche di movimento degli esercizi
- Modalità di terapia fisica
- Esercizio
- Yoga
Altri numeri di identificazione dello studio
- FTREK25/92
Piano per i dati dei singoli partecipanti (IPD)
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