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Lifestyle Intervention in Obstructive Sleep Apnoea

This study has been completed.
Sponsor:
Collaborator:
Sheffield Hallam University
Information provided by (Responsible Party):
Garry Tew, Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01546792
First received: February 27, 2012
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Obstructive Sleep Apnoea
Obesity
Behavioral: Combined lifestyle intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Body mass [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Incremental shuttle walk performance [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (EQ-5D and EQ-VAS) [ Time Frame: 13 and 25 weeks ] [ Designated as safety issue: No ]
  • Body fat percentage [ Time Frame: 13 and 25 weeks ] [ Designated as safety issue: No ]
  • Resting blood pressure [ Time Frame: 13 and 25 weeks ] [ Designated as safety issue: No ]
  • Blood markers (glucose, insulin, lipids, CRP) [ Time Frame: 13 and 25 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care control
Leaflet on exercise and diet
Experimental: Lifestyle intervention
Exercise training (mixture of supervised and non-supervised) Dietary advice Behaviour change counselling (physical activity, diet)
Behavioral: Combined lifestyle intervention
Exercise training, dietary advice, behaviour change counselling

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546792

Locations
United Kingdom
Centre for Sport and Exercise Science, Sheffield Hallam University
Sheffield, South Yorkshire, United Kingdom, S10 2BP
Pulmonary Function Unit, Northern General Hospital
Sheffield, South Yorkshire, United Kingdom, S57AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University
Investigators
Principal Investigator: Stephen Bianchi, MD Sheffield Teaching Hospitals NHS Foundation Trust
  More Information

No publications provided by Sheffield Teaching Hospitals NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Garry Tew, Senior Research Fellow, Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01546792     History of Changes
Other Study ID Numbers: STH15488
Study First Received: February 27, 2012
Last Updated: March 1, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
exercise
diet
lifestyle
sleep apnoea
obesity

Additional relevant MeSH terms:
Apnea
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Body Weight
Dyssomnias
Nervous System Diseases
Nutrition Disorders
Overnutrition
Overweight
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 20, 2014