Lifestyle Intervention in Obstructive Sleep Apnoea
Primary Purpose
Obstructive Sleep Apnoea, Obesity
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Combined lifestyle intervention
Sponsored by
About this trial
This is an interventional prevention trial for Obstructive Sleep Apnoea focused on measuring exercise, diet, lifestyle, sleep apnoea, obesity
Eligibility Criteria
Inclusion Criteria:
- obstructive sleep apnoea patients who have been receiving CPAP therapy for at least 6 months and are known to be adherent to the treatment (>75% nightly use per week)
- clinically obese (body mass index >30)
- age 18-85 years
- able to undertake exercise testing and training
Exclusion Criteria:
- patients with any contraindications to exercise (e.g. severe hypertension, unstable arrhythmias, severe musculoskeletal injuries)
- unable to undertake the requirements of the study
- non-English speaking
- already undertaking >30 min exercise >3 times per week
- non-compliant with CPAP
- body mass index <30
- unable to provide written informed consent
Sites / Locations
- Centre for Sport and Exercise Science, Sheffield Hallam University
- Pulmonary Function Unit, Northern General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual care control
Lifestyle intervention
Arm Description
Leaflet on exercise and diet
Exercise training (mixture of supervised and non-supervised) Dietary advice Behaviour change counselling (physical activity, diet)
Outcomes
Primary Outcome Measures
Body mass
Incremental shuttle walk performance
Secondary Outcome Measures
Quality of life (EQ-5D and EQ-VAS)
Body fat percentage
Resting blood pressure
Blood markers (glucose, insulin, lipids, CRP)
Full Information
NCT ID
NCT01546792
First Posted
February 27, 2012
Last Updated
March 1, 2012
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Sheffield Hallam University
1. Study Identification
Unique Protocol Identification Number
NCT01546792
Brief Title
Lifestyle Intervention in Obstructive Sleep Apnoea
Official Title
Effects of a Lifestyle Intervention on Quality of Life, Weight Loss and Cardiovascular Risk in Patients With Obstructive Sleep Apnoea Established on Continuous Positive Airway Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Sheffield Hallam University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by interrupted breathing while sleeping. It is associated with cardiovascular problems such as high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are overweight and have impaired quality of life. Lifestyle interventions incorporating exercise training, dietary advice and behaviour change have been shown to elicit favourable changes in quality of life, body mass/composition and cardiovascular risk in a range of patient groups. However, no study has investigated the impact of lifestyle modification on such health outcomes in patients with OSAHS. This study will address this issue by investigating the effects of a lifestyle intervention on quality of life, body mass/composition and cardiovascular risk in patients with OSAHS. A total of 60 volunteers will be recruited and randomly allocated to one of the two groups. Patients in the intervention group will be offered a 12-week individualised lifestyle programme consisting of supervised exercise training, dietary advice and behaviour change counselling. Patients in the control group will receive an educational booklet detailing healthy eating and exercise guidelines but no supervised or structured intervention. The results of this study will inform the design of a larger, multi-centre randomised controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnoea, Obesity
Keywords
exercise, diet, lifestyle, sleep apnoea, obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care control
Arm Type
No Intervention
Arm Description
Leaflet on exercise and diet
Arm Title
Lifestyle intervention
Arm Type
Experimental
Arm Description
Exercise training (mixture of supervised and non-supervised) Dietary advice Behaviour change counselling (physical activity, diet)
Intervention Type
Behavioral
Intervention Name(s)
Combined lifestyle intervention
Intervention Description
Exercise training, dietary advice, behaviour change counselling
Primary Outcome Measure Information:
Title
Body mass
Time Frame
25 weeks
Title
Incremental shuttle walk performance
Time Frame
25 weeks
Secondary Outcome Measure Information:
Title
Quality of life (EQ-5D and EQ-VAS)
Time Frame
13 and 25 weeks
Title
Body fat percentage
Time Frame
13 and 25 weeks
Title
Resting blood pressure
Time Frame
13 and 25 weeks
Title
Blood markers (glucose, insulin, lipids, CRP)
Time Frame
13 and 25 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
obstructive sleep apnoea patients who have been receiving CPAP therapy for at least 6 months and are known to be adherent to the treatment (>75% nightly use per week)
clinically obese (body mass index >30)
age 18-85 years
able to undertake exercise testing and training
Exclusion Criteria:
patients with any contraindications to exercise (e.g. severe hypertension, unstable arrhythmias, severe musculoskeletal injuries)
unable to undertake the requirements of the study
non-English speaking
already undertaking >30 min exercise >3 times per week
non-compliant with CPAP
body mass index <30
unable to provide written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Bianchi, MD
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Sport and Exercise Science, Sheffield Hallam University
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2BP
Country
United Kingdom
Facility Name
Pulmonary Function Unit, Northern General Hospital
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S57AU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25136550
Citation
Moss J, Tew GA, Copeland RJ, Stout M, Billings CG, Saxton JM, Winter EM, Bianchi SM. Effects of a pragmatic lifestyle intervention for reducing body mass in obese adults with obstructive sleep apnoea: a randomised controlled trial. Biomed Res Int. 2014;2014:102164. doi: 10.1155/2014/102164. Epub 2014 Jul 21.
Results Reference
derived
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Lifestyle Intervention in Obstructive Sleep Apnoea
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