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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01546792
Other study ID # STH15488
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received February 27, 2012
Last updated March 1, 2012
Start date January 2010
Est. completion date December 2011

Study information

Verified date March 2012
Source Sheffield Teaching Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Behavioral:
Combined lifestyle intervention
Exercise training, dietary advice, behaviour change counselling

Locations

Country Name City State
United Kingdom Centre for Sport and Exercise Science, Sheffield Hallam University Sheffield South Yorkshire
United Kingdom Pulmonary Function Unit, Northern General Hospital Sheffield South Yorkshire

Sponsors (2)

Lead Sponsor Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust Sheffield Hallam University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body mass 25 weeks No
Primary Incremental shuttle walk performance 25 weeks No
Secondary Quality of life (EQ-5D and EQ-VAS) 13 and 25 weeks No
Secondary Body fat percentage 13 and 25 weeks No
Secondary Resting blood pressure 13 and 25 weeks No
Secondary Blood markers (glucose, insulin, lipids, CRP) 13 and 25 weeks No
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