NCT01930513

Brief 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. 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. 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. 3.The investigators will compare commonly used exercise tests with levels of daily physical activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

July 15, 2013

Last Update Submit

January 4, 2016

Conditions

Obstructive Sleep ApneaObesity

Keywords

ObesityObstructive Sleep ApneaExerciseWalking testsCardiopulmonary exercise testsPhysical activity

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

  • Six minute walk test (6MWT)

    Four weeks

  • Incremental Treadmill Test (ITM)

    Four weeks

  • Incremental cycle test (ICE)

    Four weeks

  • Endurance cycle ergometer

    Four weeks

  • Endurance treadmill test

    Four weeks

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Obstructive Sleep Apnea

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 24577643DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveObesityMotor Activity

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Roger S Goldstein, MBChB

    West Park Healthcare Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Respirologist

Study Record Dates

First Submitted

July 15, 2013

First Posted

August 29, 2013

Study Start

November 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2016

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations

CA(1)