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Obstructive Sleep ApneaNCT01930513

Exercise Capacity and Daily Physical Activity in Obese Subjects With Treated Obstructive Sleep Apnea

An observational study of Obstructive Sleep Apnea and Obesity, run by West Park Healthcare Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea, Obesity
How many people
16 participants
Where
1 siteCanada
Study dates
Nov 2010to Jan 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Obstructive Sleep Apnea

Who may be able to join

  • Obstructive Sleep Apnea
  • Obesity BMI>30
  • Controlled on Continuous Positive Airway Pressure for three months

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • West Park Healthcare Centre

    Toronto, Ontario, M6M 2J5

Other trials in Canada

About this study

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.

Keywords
Obesity, Obstructive Sleep Apnea, Exercise, Walking tests, Cardiopulmonary exercise tests, Physical activity
Medical subject headings
Sleep Apnea, Obstructive, Obesity, Motor Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

Secondary outcomes (6)

  1. Six minute walk test (6MWT)

    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.

    Measured: Four weeks

  2. Incremental Treadmill Test (ITM)

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

    Measured: Four weeks

  3. Incremental cycle test (ICE)

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

    Measured: Four weeks

  4. Endurance cycle ergometer

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

    Measured: Four weeks

  5. Endurance treadmill test

    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

    Measured: Four weeks

  6. Daily physical activity

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

    Measured: Four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2013 (estimated)
  2. Study startNov 2010
  3. Primary completionJan 2012
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01930513
Sponsor's protocol ID
RG2010OSA
Status last verified
Jan 2016
First submitted
15 Jul 2013
Last updated
5 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • Evans RA, Dolmage TE, Robles PG, Goldstein RS, Brooks D. Do field walking tests produce similar cardiopulmonary demands to an incremental treadmill test in obese individuals with treated OSA? Chest. 2014 Jul;146(1):81-87. doi: 10.1378/chest.13-2060.

    PubMed 24577643

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea and Obesity, run by West Park Healthcare Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01930513, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.

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