- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Ontario
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Toronto, Ontario, Kanada, M6M 2J5
- West Park Healthcare Centre
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Peak oxygen uptake (Peak VO2) measured at the end of the Incremental Shuttle Walk Test (ISWT)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Six minute walk test (6MWT)
Tidsram: Four weeks
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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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Four weeks
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A sensewear armband will be worn for 7 days and only taken off for showering/bathing.
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Four weeks
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Roger S Goldstein, MBChB, West Park Healthcare Centre
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RG2010OSA
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Kliniska prövningar på Fetma
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SanionaAvslutadHypothalamic Injury-induced Obesity (HIO)Danmark