Lifestyle Intervention in Obstructive Sleep Apnoea

Phase 2

Completed

• Conditions: Obstructive Sleep Apnoea; Obesity
• Interventions: Behavioral: Combined lifestyle intervention

• Registration Number: NCT01546792
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2012-02-27
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-01
• Last Update Submitted: 2012-03-01
• Study First Posted: 2012-03-07
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	Combined lifestyle intervention	Exercise training (mixture of supervised and non-supervised) Dietary advice Behaviour change counselling (physical activity, diet)

Primary Outcome Measures

Name	Time	Method
Incremental shuttle walk performance	25 weeks
Body mass	25 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life (EQ-5D and EQ-VAS)	13 and 25 weeks
Body fat percentage	13 and 25 weeks
Resting blood pressure	13 and 25 weeks
Blood markers (glucose, insulin, lipids, CRP)	13 and 25 weeks

Trial Locations

Locations (2)

Pulmonary Function Unit, Northern General Hospital; 🇬🇧 Sheffield, South Yorkshire, United Kingdom

Centre for Sport and Exercise Science, Sheffield Hallam University; 🇬🇧 Sheffield, South Yorkshire, United Kingdom