Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000961347
Ethics application status
Approved
Date submitted
23/06/2017
Date registered
4/07/2017
Date last updated
24/07/2020
Date data sharing statement initially provided
11/06/2019
Date results information initially provided
11/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of physical activity and text-messaging on exercise levels in obstructive sleep apnoea (OSA).
Scientific title
Can physical activity intervention and/or text messaging improve functional exercise capacity and self-efficacy in adults with OSA?
Secondary ID [1] 292307 0
Nil known
Universal Trial Number (UTN)
U1111-1197-7314
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 303619 0
Condition category
Condition code
Respiratory 303028 303028 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a three-arm intervention as follows:
Group 1 will attend a 1 hour supervised group exercise session, once/week for 12 weeks,
Group 2 will attend a 1 hour supervised group exercise session once/week for 12 weeks and will receive 5-7 personalised text messages each week for those 12 weeks, followed by a gradually reducing number for an additional 12 weeks.
Group 3 will be provided with an individual exercise programme to follow unsupervised for 12 weeks and receive 5-7 personalised text messages each week for those 12 weeks, followed by a gradually reducing number for an additional 12 weeks. In groups 2 and 3, the number of text messages will be reduced by one every fortnight, resulting in a single text message being sent in the final two weeks of the study (weeks 23 and 24).
Participants will be encouraged to undertake all physical activity at a moderate intensity, working at level 4-6 on the modified Borg RPE scale. The group exercise will be supervised by an experienced physiotherapist with at least 10 years experience, and comprise both aerobic and resistance exercises including, but not limited to, static bike, rower, free weights and resistance bands. Exercise prescription, in terms of duration, resistance, repetitions and number of sets, will be specific to the individual participant. The group exercise will be conducted at a University gym facility. Participants in all groups will be encouraged to exercise at moderate intensity throughout the study duration. Those participants undertaking unsupervised exercise will be encouraged to aim for NZ Ministry of Health guidelines of two and a half hours of moderate physical activity spread throughout the week (e.g. 30 minutes, 5 days a week), and muscle strengthening activities at least two days a week.
Personalised text messages will be motivational in nature and the content will be determined by participant information provided at baseline assessment. These will be uni-directional with no response required from participants. If participants require advice/extra support, a contact phone number will be provided at commencement of the study.
Intervention code [1] 298325 0
Rehabilitation
Intervention code [2] 298326 0
Lifestyle
Intervention code [3] 298327 0
Behaviour
Comparator / control treatment
The comparator group is group 3 who will receive no supervised exercise intervention. They will, however, receive tailored text messages at the same frequency, and over the same time period, as Group 2. Participants in group 3 will be provided with information regarding the current NZ Ministry of Health guidelines for physical activity and a personalised physical activity plan, They will be encouraged to walk 5 days a week, at moderate intensity, aiming for a cumulative total of 150 minutes and will be provided with suggestions on how best to achieve this. Each participant will also be provided with an upper limb strengthening programme (10 repetitions of each exercise x 3 sets) to be carried out twice a week.
Control group
Active

Outcomes
Primary outcome [1] 302401 0
Functional exercise capacity as measured using the six minute walk test
Timepoint [1] 302401 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement
Secondary outcome [1] 335850 0
Moderate-vigorous physical activity behaviour as measured by 7 days of accelerometry data
Timepoint [1] 335850 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement
Secondary outcome [2] 335851 0
Quality of life as measured by the following questionnaires: Short Form 36 (SF-36) and Functional Outcomes of Sleep Questionnaire (FOSQ)
Timepoint [2] 335851 0
Baseline, and at 6 weeks, 12 weeks and 24 weeks after intervention commencement
Secondary outcome [3] 335852 0
Sleep duration/disturbance as measured using overnight accelerometry
Timepoint [3] 335852 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement
Secondary outcome [4] 335853 0
Gait speed measured over a 10 metre walking distance
Timepoint [4] 335853 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement
Secondary outcome [5] 335854 0
Muscle strength using a handheld dynamometer
Timepoint [5] 335854 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement
Secondary outcome [6] 335855 0
Depressive symptoms as measured using the Patient Health Questionnaire (PHQ-9)
Timepoint [6] 335855 0
Baseline, and at 6 weeks, 12 weeks and 24 weeks after intervention commencement
Secondary outcome [7] 336438 0
Level of self-efficacy as measured by the General Self-Efficacy Scale.
Timepoint [7] 336438 0
Baseline, and at 6 weeks, 12 weeks and 24 weeks after intervention commencement.
Secondary outcome [8] 336439 0
Sedentary time as measured by accelerometry
Timepoint [8] 336439 0
Baseline, and at 12 weeks and 24 weeks after intervention commencement

Eligibility
Key inclusion criteria
Adults referred to the Dunedin Sleep Clinic with symptoms indicative of OSA and with an Epworth Sleepiness Scale score of 11 or greater, and able to walk independently with or without a walking aid
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• An overnight sleep study result with no diagnosis of OSA (excluded from study data analysis)
• Uncontrolled hypertension or unstable angina
• Inability to participate in exercise-based physical activity
• Inability to provide informed consent
• Inability to complete health related questionnaires independently and in English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot study, we are aiming for n=12 per group (total = 36)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2017
Actual
21/02/2018
Date of last participant enrolment
Anticipated
14/09/2018
Actual
30/05/2019
Date of last data collection
Anticipated
30/11/2019
Actual
17/11/2019
Sample size
Target
36
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 8996 0
New Zealand
State/province [1] 8996 0
Otago

Funding & Sponsors
Funding source category [1] 296710 0
University
Name [1] 296710 0
School of Physiotherapy, University of Otago
Country [1] 296710 0
New Zealand
Primary sponsor type
University
Name
School of Physiotherapy, University of Otago
Address
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 295745 0
None
Name [1] 295745 0
Address [1] 295745 0
Country [1] 295745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297937 0
Health and Disability Ethics Committee NZ
Ethics committee address [1] 297937 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
New Zealand
Ethics committee country [1] 297937 0
New Zealand
Date submitted for ethics approval [1] 297937 0
26/06/2017
Approval date [1] 297937 0
19/07/2017
Ethics approval number [1] 297937 0

Summary
Brief summary
Obstructive sleep apnoea (OSA) often exists in people with high blood pressure, heart disease, obesity and/or diabetes. Poor sleep quality, daytime sleepiness, fatigue, and physical inactivity are commonly associated with OSA. A graduated physical activity programme, prescribed at a level appropriate to the individual, has been shown to improve energy levels and reduce associated health risk factors; motivational text messaging may also assist.

The study will focus on engaging adults with OSA over a 12-week period involving either a physical activity programme, motivational texting or both, with the primary purpose being:
• To investigate the effects of a 12-week physical activity intervention on physical activity behaviour and a range of relevant health outcomes.
• To compare activity levels and sedentary time during a physical activity programme with and without tailored text messaging intervention.
• To compare physical activity behaviour in those undergoing CPAP treatment with those who are not.
• To objectively measure physical activity levels at three time points (baseline, 12 and 24 weeks) in conjunction with a supervised exercise intervention and compare levels with current World Health Organization weekly recommendations.

Participants will be allocated to one of three groups - ( 1) once weekly supervised exercise group, (2) once weekly supervised exercise group plus tailored text messaging, or (3) tailored text messaging only.

Individuals will be provided with a device for measuring activity levels (Actigraph accelerometer) at initial assessment and asked to wear this for seven days and nights, to provide baseline physical activity levels, sedentary time and sleep quality and duration. Wearing of the accelerometer will be repeated for another seven-day period for comparison at 12 weeks, and 24 weeks. In addition, various measurements such as height, weight, blood pressure and waist circumference will be take at each of the three time points. Various questionnaires related to quality of life and self-efficacy will be undertaken at baseline, 6 weeks, 12 weeks and 24 weeks.

The weekly supervised group exercise will comprise both aerobic and resistance exercises, and be supervised by a physiotherapist. Those in the text messaging groups will receive personalised text messages sent between five and seven times a week throughout the initial 12 weeks, and for 12 weeks afterwards at a decreasing rate.

Expected outcomes will be: (1) Analysis of the effects of a 12-week physical activity intervention on physical activity behaviour and a range of relevant health outcomes and comparison with World Health Organisation weekly recommendations; (2) Comparison of activity levels and sedentary time between groups participating in a physical activity programme with and without tailored text messaging intervention; (3) Comparison of physical activity behaviour in those undergoing CPAP treatment with those who are not.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1795 1795 0 0
/AnzctrAttachments/373114-PhD study protocol 18062017.docx (Protocol)

Contacts
Principal investigator
Name 75514 0
Mrs Sarah Rhodes
Address 75514 0
University of Otago
School of Physiotherapy
PO Box 56
Dunedin 9054
New Zealand
Country 75514 0
New Zealand
Phone 75514 0
+64 3 479 7460
Fax 75514 0
Email 75514 0
[email protected]
Contact person for public queries
Name 75515 0
Mrs Sarah Rhodes
Address 75515 0
University of Otago
School of Physiotherapy
PO Box 56
Dunedin 9054
New Zealand
Country 75515 0
New Zealand
Phone 75515 0
+64 3 479 7460
Fax 75515 0
Email 75515 0
[email protected]
Contact person for scientific queries
Name 75516 0
Dr Margot Skinner
Address 75516 0
University of Otago
School of Physiotherapy
PO Box 56
Dunedin 9054
New Zealand
Country 75516 0
New Zealand
Phone 75516 0
+64 3 479 7466
Fax 75516 0
Email 75516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Collective data analysis only


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.