Condition category
Nervous System Diseases
Date applied
20/07/2020
Date assigned
21/07/2020
Last edited
14/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

Plain English Summary

Background and study aims
Obstructive sleep apnoea (often abbreviated as OSA) is a condition that causes the airway of sufferers to close on multiple occasions during sleep, which temporarily interrupts breathing. OSA is more prevalent in obese individuals and even more prevalent to those who are older. The only effective treatment currently is the use of Continuous Positive Airway Pressure (CPAP), which requires a face mask to be worn during sleep. The adherence to this treatment is poor because the majority of patients find it uncomfortable to wear and socially obtrusive. Exercise has been shown to improve the condition but the feasibility of changing patients' behaviour consistently for exercise to be used as a potential mode of treatment is not well described.

Who can participate?
Adult manual workers aged between 50 and 69 years old with no previous diagnosis or treatment for obstructive sleep apnoea and no history of chest pain during exercise or any kind of heart trouble

What does the study involve?
The study is a 12-week physical activity intervention that requires participants to gradually increase the duration and intensity of their daily physical activity such as walking, daily household tasks (e.g. gardening). Participants are asked to report their total daily amount of physical activity and intensity to an investigator via text message. Levels of physical activity are also monitored by accelerometers at three timepoints for 7 days (during weeks 1, 6, and 12) to validate self-reported physical activity. At the end of the 12-week period, measurements are compared to those taken at the start of the study to assess the effectiveness of the intervention.

What are the possible benefits and risks of participating?
Engaging in physical activity regularly is considered to be a health benefit for everyone and participants in this study will gain these health benefits by increasing the amount of time that they spend being active. The particular benefit to the participants recruited for this study may also have a direct benefit towards the severity of the OSA condition with which they are suffering. An improvement in the severity of the condition due to increased activity levels will reduce the negative results of OSA which are sleepiness, tiredness and deterioration of heart health. The risks of participating in this study relate solely to the participant’s engagement with exercise. Potential risks of exercise in older adults include possible musculoskeletal injuries and complications secondary to an undiagnosed heart condition. The gradual increase in exercise duration and intensity in this study minimises these risks.

Where is the study run from?
University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
March 2017 to December 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr George Balanos
g.m.balanos@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr George Balanos

ORCID ID

Contact details

University of Birmingham
School of Sport
Exercise and Rehabilitation Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 4158828
g.m.balanos@bham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

The implementation of a physical activity intervention in adults with obstructive sleep apnoea over the age of 50 years: a feasibility uncontrolled clinical trial

Acronym

AROSA

Study hypothesis

Physical activity can improve cardiorespiratory fitness and improve the severity of obstructive sleep apnoea possibly via facilitating upper airway adaption and rostral fluid shift.

Ethics approval

Approved 08/08/2017, University of Birmingham Science, Technology, Engineering and Mathematics Ethical Review Committee (Research Support Group, C Block Dome (room 132), Aston Webb Building, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK; +44 (0)121 414 8101; ethics-queries@contacts.bham.ac.uk or s.m.waldron@bham.ac.uk), ref: ERN_16-1326A

Study design

Single-centre non-randomized interventional feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Obstructive sleep apnoea

Intervention

Overnight screening for Obstructive Sleep Apnoea (OSA) indicates eligible participants with an Apnoea Hypopnoea Index (AHI) score greater than 15 who are then invited to take part in the intervention. Prior to the intervention, a screening questionnaire pertaining to the participants’ general health is administered and baseline anthropometric measurements are recorded. All participants are invited to complete a questionnaire to measure current daily physical activity levels.

Participants are advised in a face-to-face session with an investigator, as to how to increase the frequency, duration and intensity of their current physical activity (PA) levels over the following 12 weeks. Participants are asked to report their total daily amount of PA and intensity (Rate of Perceived Exertion, RPE) as two numbers to the mobile phone of an investigator via text message. Levels of PA are also monitored by accelerometers at three timepoints for 7 days (during weeks 1, 6, and 12) to validate self-reported PA. Total minimum accelerometer wear time required is 12 hours for seven consecutive days. At the end of the 12-week period, post-intervention measurements including AHI are taken as described earlier and compared to those at baseline to assess the effectiveness of the intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Feasibility of increasing the duration and intensity of weekly physical activity: participant compliance and adherence to the intervention measured using daily self-reporting via text messaging, objectively confirmed using accelerometry for seven consecutive days during week 6 and week 12

Secondary outcome measures

1. Physical activity measured subjectively using the short form International Physical Activity Questionnaire (IPAQ) at baseline and 12 weeks
2. Physical activity measured objectively using accelerometry at baseline, 6 weeks and 12 weeks
3. The presence and severity of Obstructive Sleep Apnea (OSA) evaluated using the Apnoea/Hypopnoea Index (AHI) using a domiciliary testing device (ApneaLink Air) at baseline and 12 weeks
4. Anthropometric measurements: BMI (kg/m2) and weight and body fat percentage measured using bioelectrical impedance at baseline and 12 weeks

Overall trial start date

27/03/2017

Overall trial end date

07/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult manual workers
2. Aged between 50 and 69 years old
3. No previous diagnosis or treatment for obstructive sleep apnoea
4. No history of chest pain during exercise or heart trouble
5. Employed for at least the previous 3 months or longer

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

10 participants for a feasibility study

Total final enrolment

10

Participant exclusion criteria

1. Younger than 50 or older than 69 years old
2. Unemployed or employed for less than 3 months
3. Previous diagnosis or treatment for obstructive sleep apnoea
4. History of chest pain during exercise or heart trouble

Recruitment start date

08/08/2017

Recruitment end date

04/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
School of Sport, Exercise and Rehabilitation Sciences Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

c/o Birgit Whitman
College of Life and Environmental Sciences
School of Sport
Exercise and Rehabilitation Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 415 8011
B.Whitman@bham.ac.uk

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/index.aspx

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results of the trial, specifically the potential of physical activity to reduce OSA.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr George Balanos (g.m.balanos@bham.ac.uk). The data that can be provided will be anonymised participant-level detail of the variables reported in the relevant publication. The data will be made available upon publication of the study (August 2020). Data will be made available for research purposes (such as systematic reviews) and the files containing these data will be shared via encrypted email. Participants have indicated that they consent for their data to be used in future data analysis but this was not explicitly in relation to data sharing.

Intention to publish date

01/08/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

2020 results in https://pubmed.ncbi.nlm.nih.gov/32782808/ (added 14/08/2020)

Publication citations

Additional files

Editorial Notes

14/08/2020: Publication reference added. 21/07/2020: Trial's existence confirmed by University of Birmingham Science, Technology, Engineering and Mathematics Ethical Review Committee.