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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01930513
Exercise Capacity and Daily Physical Activity in Obese Subjects With Treated Obstructive Sleep Apnea
Obesity is very common worldwide and breathing problems at night (obstructive sleep apnea, OSA) are common in obesity. Despite the best treatment, obesity and OSA are linked to early death from heart problems. They are also associated with lower levels of physical activity. Exercise strategies for weight loss, increasing physical activity and improving fitness are needed for obesity. In Obese individuals with OSA
- The investigators will compare corridor walking tests compared to laboratory exercise tests. The null hypothesis is that the peak oxygen uptake achieved and the cardiopulmonary response during both the six-minute walk test and Incremental Shuttle Walk Test would not be different from that observed during an Incremental Treadmill Test.
- The investigators will investigate whether cycling or walking uses more calories for the same intensity. We hypothesise that cycling (weight supported) will be endured for long.
- The investigators will compare commonly used exercise tests with levels of daily physical activity.
The information from these three projects will help us set up the optimal exercise program for obese individuals.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M6M 2J5
- West Park Healthcare Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Obstructive Sleep Apnea
- Obesity BMI>30
- Controlled on Continuous Positive Airway Pressure for three months
Exclusion Criteria:
- cardiac co-morbidity e.g ischaemic heart disease, chronic heart failure, valvular heart disease
- pulmonary co-morbidity
- neurological condition limiting the ability to perform walking or cycling
- orthopaedic condition limiting the ability to perform walking or cycling
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Peak oxygen uptake (Peak VO2) measured at the end of the Incremental Shuttle Walk Test (ISWT)
Lasso di tempo: All outcome measures will be performed within four weeks of each other
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Two Incremental Shuttle Walk tests will be performed within two hours on the same day with expired gas analysis measured by a portable gas analyser.
An ISWT is conducted over a 10m course and the speed is externally paced and increases each minute.
The participant is asked to continue until they are either too breathless or too tired to continue.
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All outcome measures will be performed within four weeks of each other
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Six minute walk test (6MWT)
Lasso di tempo: Four weeks
|
The 6MWT will be performed over a 30 m level, straight course within an enclosed corridor.
The test protocol described by the American Thoracic Society will be modified to include standardized encouragement every 15 seconds to recommence walking if the participant chooses to rest during the test.
Participants will be familiarized with the test prior to participating in the study and, therefore, only one test will be performed.
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Four weeks
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Incremental Treadmill Test (ITM)
Lasso di tempo: Four weeks
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A maximal treadmill test will be performed once with expired gas analysis.
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Four weeks
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Incremental cycle test (ICE)
Lasso di tempo: Four weeks
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A maximal symptom limited cardio-pulmonary exercise test on a cycle ergometer.
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Four weeks
|
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Endurance cycle ergometer
Lasso di tempo: Four weeks
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Two endurance cycle tests will performed at 60% and 80% of the maximal peak oxygen obtained on either the ICE or ITM
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Four weeks
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Endurance treadmill test
Lasso di tempo: Four weeks
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Constant speed endurance treadmill test will be performed at 60% and 80% of the peak oxygen uptake achieved on either the ITM or ICE to symptom limitation
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Four weeks
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Daily physical activity
Lasso di tempo: Four weeks
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A sensewear armband will be worn for 7 days and only taken off for showering/bathing.
|
Four weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Roger S Goldstein, MBChB, West Park Healthcare Centre
Pubblicazioni e link utili
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RG2010OSA
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 .