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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930513
• Other study ID #: RG2010OSA
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: January 4, 2016
• Start date: November 2010
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: West Park Healthcare Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health CanadaCanada: Ministry of Health & Long Term Care, Ontario
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2016
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Obesity
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Canada	West Park Healthcare Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
West Park Healthcare Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	All outcome measures will be performed within four weeks of each other	No
Secondary	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.	Four weeks	No
Secondary	Incremental Treadmill Test (ITM)	A maximal treadmill test will be performed once with expired gas analysis.	Four weeks	No
Secondary	Incremental cycle test (ICE)	A maximal symptom limited cardio-pulmonary exercise test on a cycle ergometer.	Four weeks	No
Secondary	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	Four weeks	No
Secondary	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	Four weeks	No
Secondary	Daily physical activity	A sensewear armband will be worn for 7 days and only taken off for showering/bathing.	Four weeks	No