Exercise Training and Weight Loss in Overweight Patients With Obstructive Sleep Apnoeal Hypopnoea Syndrome Receiving Treatment With Continuous Positive Airway Pressure (CPA)

Completed

• Conditions: ervous System Diseases: Obstructive Sleep Apnoea/Hypopnoea Syndrome; Nervous System Diseases; Obstructive Sleep Apnoea/Hypopnoea Syndrome

• Registration Number: ISRCTN94385228
• Lead Sponsor: Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Research participants will be recruited from those attending a specialist OSAHS clinic based at the Lung Investigation Unit, Queen Elizabeth Hospital. Suitable patients will be identified by the Consultant Clinical Scientist treating the patients at the clinic. The Consultant Clinical Scientist will approach the patients during scheduled clinic visits in order to explain the purpose and nature of the research and to ask for their potential involvement. At this time patients will be given a patient information sheet to read and will be allowed to take this home in order to think about participation and any questions they may have regarding the study requirements and protocol.

Following this, interested patients will be asked to return to the department of respiratory medicine for further explanation of the study and to sign a consent form regarding participation. At this time patients will be required to undergo a medical examination in order to ensure that they meet the inclusion/exclusion criteria for participation.

Principal inclusion criteria:
1. Patients must be established on CPAP therapy as the aim of the study is to compare usual care with exercise training/dietary intervention
2. Diagnosis of OSAI-IS (SIGN guidelines, 2003): Overweight (BMI>25kg/m2). Patients must be overweight in order to benefit from the exercise training and weight loss programmes. OSAHS that is not attributable to being overweight will not be expected to improve at the end of the programme
3. Evidence of daytime somnolence (Epworth> 10.0). Daytime somnolence is a potentially disabling symptom of OSAHS and would be expected to improve with a reduction in severity of OSAHS
4. Documentation of symptoms such as snoring, cognitive impairment and sleep fragmentation

Exclusion Criteria

1. Unstable heart disease or angina which may pose risks for the performance of exercise
2. Untreated hypothyroidism. This may decrease the effectiveness of a weight loss regime and therefore decrease the validity of the study
3. Severe lung disease. Patients with severe lung disease may be unable to tolerate a high intensity exercise programme and may require ventilation with CPAP despite being of a normal weight.
4. Pregnancy. High intensity exercise and strict dietary modification are not recommended for those who may be pregnant as this may result in damage to the developing foetus.
5. Facial abnormalities. Individuals in which facial abnormalities may contribute to the severity of OSA1~IS would not be expected to benefit from weight loss strategies and may require CPA even when of a normal weight.
6. Eating disorders. Individuals with eating disorders would be unlikely to benefit from the dietary and exercise training programme and should be given help and advice for this problem rather than being recruited to the study
7. Arthritis. Patients with severe arthritis will not be able to perform the exercise training sessions

Study & Design

• Study Type: Interventional
• Study Design: Not specified