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Completed

NCT Number: 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

1. 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. 2. 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. 3. 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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Behavior Body Weight Dyssomnias Motor Activity Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Peak oxygen uptake (Peak VO2) measured at the end of the Incremental Shuttle Walk Test (ISWT)

    Time frame: All outcome measures will be performed within four weeks of each other

    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.

Secondary outcomes

  1. Six minute walk test (6MWT)

    Time frame: 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.

  2. Incremental Treadmill Test (ITM)

    Time frame: Four weeks

    A maximal treadmill test will be performed once with expired gas analysis.

  3. Incremental cycle test (ICE)

    Time frame: Four weeks

    A maximal symptom limited cardio-pulmonary exercise test on a cycle ergometer.

  4. Endurance cycle ergometer

    Time frame: Four weeks

    Two endurance cycle tests will performed at 60% and 80% of the maximal peak oxygen obtained on either the ICE or ITM

  5. Endurance treadmill test

    Time frame: Four weeks

    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

  6. Daily physical activity

    Time frame: Four weeks

    A sensewear armband will be worn for 7 days and only taken off for showering/bathing.

Sponsors and collaborators

Lead sponsor

West Park Healthcare Centre

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2016
First posted
Aug 29, 2013
Registry last updated
Jan 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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