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

January 4, 2016 updated by: Roger Goldstein, West Park Healthcare Centre

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6M 2J5
        • West Park Healthcare Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Obstructive Sleep Apnea

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
All outcome measures will be performed within four weeks of each other

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four weeks
Incremental Treadmill Test (ITM)
Time Frame: Four weeks
A maximal treadmill test will be performed once with expired gas analysis.
Four weeks
Incremental cycle test (ICE)
Time Frame: Four weeks
A maximal symptom limited cardio-pulmonary exercise test on a cycle ergometer.
Four weeks
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
Four weeks
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
Four weeks
Daily physical activity
Time Frame: Four weeks
A sensewear armband will be worn for 7 days and only taken off for showering/bathing.
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Park Healthcare Centre

Investigators

  • Principal Investigator: Roger S Goldstein, MBChB, West Park Healthcare Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

August 23, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG2010OSA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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