- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02534831
Manual Therapy in Chronic Obstructive Pulmonary Disease
The Effect of Soft Tissue Manual Therapy Intervention on Lung Function in Severe Chronic Obstructive Pulmonary Disease: a Proof of Concept Study
Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease characterized by progressive airflow limitation that is associated with an inflammatory response to noxious particles or gases.
Manual therapy (MT) has been defined as a therapeutic intervention that uses the hands to provide treatment to the musculoskeletal and/or visceral systems. It includes techniques such as massage, myofascial release, muscle energy technique, ligament balance, joint mobilization and joint manipulation. The suggestion that MT could deliver long-term benefits to people with COPD was first put forward in 2009. Since then a number of small studies have reported medium term improvements in lung function and exercise capacity following repeated applications of MT intervention.
Our aim is to measure the immediate effect on lung function of a single application of soft tissue manual therapy in patients with severe and very-severe chronic obstructive pulmonary disease.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease characterized by progressive airflow limitation that is associated with an inflammatory response to noxious particles or gases.
Changes in the anatomy of the airways and lung parenchyma occur as the result of bronchial hypersecretion and bronchoalveolar instability which cause expiratory flow limitation and air trapping. This is known clinically as dynamic hyperinflation. The phenomenon leads to an increase in expiratory reserve volume, residual volume and functional residual capacity, also referred to as end expiratory lung volume. These increases limit tidal volume and inspiratory reserve volume eventually affecting inspiratory capacity. They alter the position of the ribs causing a state similar to sustained inspiration over time, often referred to as 'inspiratory block'. This phenomenon is responsible for the characteristic 'barrel chest' commonly seen in patients with more advanced stages of COPD. In this state the position of the diaphragm is flattened and shortened reducing its ability to generate force. Accessory respiratory muscles are recruited as a compensatory adaptation leading to shortening and over-activation of these muscles over time (over-adaptation). The surrounding cervicothoracic fascia contracts producing postural changes such as anterior projection of the head, neck hyperextension, increased thoracic kyphosis and internal rotation of shoulders. These changes contribute to an increase in chest tightness, a decrease in the ability to generate inspiratory pressures and volumes and an increase in the amount of effort required to breath.
Manual therapy (MT) has been defined as a therapeutic intervention that uses the hands to provide treatment to the musculoskeletal and/or visceral systems. It includes techniques such as massage, myofascial release, muscle energy technique, ligament balance, joint mobilization and joint manipulation. The suggestion that MT could deliver long-term benefits to people with COPD was first put forward in 2009. Since then a number of small studies have reported medium term improvements in lung function and exercise capacity following repeated applications of MT intervention.
Our aim is to measure the immediate effect on lung function of a single application of soft tissue manual therapy in patients with severe and very-severe chronic obstructive pulmonary disease.
We recruitment patients with COPD in Rehabilitation Program in Hospital San José de Santiago de Chile, and we assessment: total lung capacity (TLC); vital capacity (VC); residual volume (RV); expiratory reserve volume (ERV); inspiratory capacity (IC); and airway resistance (Raw). Secondary: heart rate (HR); respiratory rate (RR); and oxygen saturation (SpO2).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Metropolitan Región
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Santiago, Metropolitan Región, Chile, 8380239
- Department of Physical Therapy, University of Chile
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosis of severe or very severe COPD (GOLD: Stage III or IV)
- Medically stable with no exacerbations in the preceding two months
Exclusion Criteria:
- A rheumatoid condition
- Neuromuscular or musculoskeletal pathology
- Cognitive disability that could influence their understanding or execution of the assessment tests or intervention protocol
- Supplemental oxygen dependency
- Previous or current enrollment in other pulmonary rehabilitation program
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Soft Tissue Manual Therapy Protocol
Soft tissue manual therapy protocol.
Seven techniques of manual therapy in 30 minutes.
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The STMTP consisted of a pre-determined set of seven (7) soft tissue techniques delivered as part of a single treatment session lasting approximately 30 minutes.
The techniques and their respective durations were: suboccipital release (5 minutes), anterior thoracic myofascial and sternum release (5 minutes), anterior cervical myofascial release (5 minutes), costal ligament balance (5 minutes) and muscular energy technique (MET) to the following muscles - scalenes (1 minute and 40 seconds), pectoralis minor (1 minute and 40 seconds) and latissimus dorsi and serratus anterior (1 minute and 40 seconds)
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total Lung Capacity
Lasso di tempo: 30 minutes
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Units in ml
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30 minutes
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Vital Capacity
Lasso di tempo: 30 minutes
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Units in ml
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30 minutes
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Residual volume
Lasso di tempo: 30 minutes
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units in ml
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30 minutes
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Roger Engel, PhD, Macquarie University, Australia
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KIN2012-1
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Soft tissue manual therapy protocol
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