Clinical trial NCT01546792: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obstructive Sleep Apnoea
Obesity
Keywords: exercise
diet
lifestyle
sleep apnoea
obesity
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Sheffield Hallam University
First posted: 2012-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Body mass
timeFrame: 25 weeks
measure: Incremental shuttle walk performance
timeFrame: 25 weeks
Secondary outcomes:
measure: Quality of life (EQ-5D and EQ-VAS)
timeFrame: 13 and 25 weeks
measure: Body fat percentage
timeFrame: 13 and 25 weeks
measure: Resting blood pressure
timeFrame: 13 and 25 weeks
measure: Blood markers (glucose, insulin, lipids, CRP)
timeFrame: 13 and 25 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Centre for Sport and Exercise Science, Sheffield Hallam University
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: Pulmonary Function Unit, Northern General Hospital
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Stephen Bianchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.