NCT01546792

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

2 active sites

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

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

1.9 years

First QC Date

February 27, 2012

Last Update Submit

March 1, 2012

Conditions

Obstructive Sleep ApnoeaObesity

Keywords

exercisedietlifestylesleep apnoeaobesity

Outcome Measures

Primary Outcomes (2)

  • Body mass

    25 weeks

  • Incremental shuttle walk performance

    25 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

Usual care control

NO INTERVENTION

Leaflet on exercise and diet

Lifestyle intervention

EXPERIMENTAL

Exercise training (mixture of supervised and non-supervised) Dietary advice Behaviour change counselling (physical activity, diet)

Behavioral: Combined lifestyle intervention

Interventions

Combined lifestyle interventionBEHAVIORAL

Exercise training, dietary advice, behaviour change counselling

Lifestyle intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre for Sport and Exercise Science, Sheffield Hallam University

Sheffield, South Yorkshire, S10 2BP, United Kingdom

Location

Pulmonary Function Unit, Northern General Hospital

Sheffield, South Yorkshire, S57AU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25136550DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveObesityMotor ActivitySleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

  • Stephen Bianchi, MD

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 7, 2012

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

GB(2)