Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001881224
Ethics application status
Approved
Date submitted
1/06/2018
Date registered
19/11/2018
Date last updated
10/12/2019
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of exercise on adults with high blood pressure resistant to drugs and with breath pauses during sleep
Scientific title
The effectiveness of a 12-week physical exercise programme on blood pressure in adults with true resistant hypertension and high risk of obstructive sleep apnoea. A pragmatic clinical trial.
Secondary ID [1] 294995 0
Nil known
Universal Trial Number (UTN)
U1111-1214-6955
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resistant hypertension 308014 0
Obstructive sleep apnoea 308015 0
Condition category
Condition code
Cardiovascular 307051 307051 0 0
Hypertension
Respiratory 307052 307052 0 0
Sleep apnoea
Physical Medicine / Rehabilitation 307199 307199 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a single group non-randomised pragmatic clinical trial. The subset with true resistant hypertension (TRHT) and high risk of obstructive sleep apnoea (OSA), n=30, will undergo a 12-week physical exercise programme. At the beginning and the end of the 12-weeks; the measurements; office blood pressure, 24h Ambulatory Blood Pressure, cardio-respiratory fitness (six-minute walk test), quality of life (SF-36V2), daytime sleepiness (Epworth Sleepiness Scale score - ESS), activity level (step count, time in low/moderate/vigorous physical activity, sedentary time), objective sleep parameters (sleep onset, total sleep time, awakenings, sleep efficiency, wake after sleep onset), echo-cardiogram (ejection fraction, left ventricular dimensions) and anthropometrics (Body Mass Index, waist to hip ratio, neck circumference), will all be measured.
A portable digital blood pressure monitor, ambulatory blood pressure monitor, accelerometer, stadiometer, weighing scale and anthropometric measurement tape will be used to obtain the measurements. Those measurements will be carried out by the principal investigator, the Ph.D. candidate who has more than 10 years of research experience, at the School of Physiotherapy, University of Otago, New Zealand.
A cardiac ultrasound machine will be used for the echocardiogram and the procedure will be carried out by qualified staff in the cardiology laboratory, at The Dunedin School of Medicine, University of Otago.
The equipment for the exercise programme is available in a gymnasium setting at the School of Physiotherapy and includes, static cycle, rowing machine, ‘Thera bands’, barbells and dumbbells.
The physical exercise programme is a specially designed and based on a programme currently in use for people with non-communicable diseases such as high blood pressure, coronary artery disease, diabetes etc. The programme consists of 1) warm up (a rhythmic activity in time with music); 2) aerobic exercises (cycling on stationary ergometer, rowing on rowing machine, rhythmic activities, based on frequency, intensity type and time or the FITT principle) undertaken at a sub-maximal level (Borg Rating of Perceived Exertion Scale); 3) resistance training (free weighs, thera-bands, based on repetition maximum principles), and flexibility components (stretching of major muscle groups), 4) warm down exercises.
All the exercise sessions will be undertaken by an experienced physiotherapist who is an academic member in the School of Physiotherapy, the University of Otago. The delivery of the exercise programme will be group based but specific to the individual’s requirements. The programme will be conducted at the School of Physiotherapy, in one hour sessions once or twice a week. At the end of the programme each day, there will be a 15-minute question and answering session where the participants will present their quarries about the programme. The importance of the continuation of activity through the week will be explained to participants to assist them with the goals and with adherence. The programme will be conducted by the same physiotherapist and the protocol for the sessions will be predetermined and recorded, to maintain consistency. A personalised home-based programme will also be given to the participants to follow up throughout the week.

The home programme (30 minutes per day and five days per week) consists of 1) warm up (a rhythmic activity in time with music ); 2) aerobic exercises (walking, brisk walking or jogging for 15 minutes) 3) resistance training (free weighs using water bottles etc, Thera-bands – as taught in the supervised program for 10 minutes) , and flexibility and 4) warm down (3 minutes) exercises. The participants will be advised to follow the programme for five days or at least 3 days. The home-based program will be given to the participant on the first day supervised programme and need to follow in the week in between supervised program. Participants will have to maintain a diary of the program which needs to get approved by the physiotherapist at the next supervised program.
Intervention code [1] 301368 0
Treatment: Other
Intervention code [2] 301369 0
Lifestyle
Intervention code [3] 301370 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306072 0
The changes of 24-hour ambulatory blood pressure of population with true resistant hypertension and high risk of obstructive sleep apnoea.

This outcome will be assessed by 24 ambulatory blood pressure monitor (Holter monitor) worn for 24 h, the blood pressure cuff fitted on the non-dominant upper arm. (ABPM - 90207, Spacelabs, Snoqualmie, Washington, USA)
Timepoint [1] 306072 0
Baseline and 12 weeks after intervention commencement.
Secondary outcome [1] 347478 0
Change of sleep parameters: [total sleep time (minutes), awakenings (number), average awakenings, sleep efficiency (ratio), sleep onset (time), latency and wake after sleep onset (seconds)]
This composite outcome will be assessed using the data collected by accelerometer worn for seven days. with true resistant hypertension and high risk of obstructive sleep apnoea.
Timepoint [1] 347478 0
Baseline (before starting the exercise program) and at the completion of the 12-week exercise program
Secondary outcome [2] 347815 0
Change of echo cardiac parameters (Left ventricular ejection fraction (LVEF%), left ventricular dimensions etc.,) in the subpopulation with true resistant hypertension and high risk of obstructive sleep apnoea.

This composite outcome will be assessed based on the echocardiogram reports based on echocardiography using ultras sound
Timepoint [2] 347815 0
Baseline (before starting the exercise program) and at the completion of the 12-week exercise program
Secondary outcome [3] 347816 0
Change of anthropometric parameters (BMI, neck circumference, weight, waist to hip ratio) in the sub-population with true resistant hypertension and high risk of obstructive sleep apnoea.

This is a composite outcome assessed by the measurements taken using the weighing scale (body weight), stadiometer (height), and anthropometric measurement tape
Timepoint [3] 347816 0
Baseline (before starting the exercise program) and at the completion of the 12-week exercise program
Secondary outcome [4] 347817 0
Change of quality of life (SF-36v2 score) in the sub-population with true resistant hypertension and high risk of obstructive sleep apnoea.
Timepoint [4] 347817 0
Baseline (before starting the exercise program) and at the completion of the 12-week exercise program
Secondary outcome [5] 354075 0
Change of activity level: (step count, time in low/moderate/vigorous physical activity/sedentary time),

This composite outcome will be assessed using the data collected by accelerometer worn for seven days. with true resistant hypertension and high risk of obstructive sleep apnoea.
Timepoint [5] 354075 0
Baseline (before starting the exercise program) and at the completion of the 12-week exercise program
Secondary outcome [6] 354076 0
Change of cardiorespiratory fitness

This outcome will be assessed by the 6-minute walk test
Timepoint [6] 354076 0
Baseline (before starting the exercise program) and at the completion of the 12-week exercise program

Eligibility
Key inclusion criteria
24h ambulatory blood pressure above 130/85 mmHg
Prescribed three or more antihypertensive medications including a diuretic
ESS score above or equal to 9
Age between 18-60 years inclusive
All gender
Fit to participate in the 12-week physical exercise programme based on the Physical Activity Readiness Questionnaire (2017 PAR-Q +) of the American College of Sports Medicine (ACSM) and recommendation of a cardiologist.
Able to communicate and follow instructions in English
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with systemic diseases, history of cardiovascular diseases (Myocardial infarction or Stroke) within 6 months and other severe heart conditions and with physical ailments, acute musculoskeletal injuries.
Not fit to exercise according to exercise readiness questionnaire and who are not recommended by the cardiologist

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)
Not applicable
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: The sample size was calculated using the 24h Ambulatory Blood Pressure Measurement (24h ABPM) as the main outcome measure.

The cohort with true resistant hypertension (TRHT) and high risk of obstructive sleep apnoea (OSA) is unknown for the Dunedin based population with RHT. The published data suggest that around 40% of those with RHT have OSA.

To obtain a 5mmHg difference in the primary outcome (24h ABPM) with standard deviation ±9 the sample size will be 28. (with a=0.05 and 80% power (ß = 0.8)). Therefore 40 will be a reasonable expectation.
Statistical methods:
Comparison of blood pressure, anthropometric, activity and echo cardiac parameters of baseline and end point of 12-week physical rehabilitation programme in the subpopulation with true resistant hypertension and high risk of obstructive sleep apnoea will be determined using the paired sample t-test. A p-value <0.05 will be considered significant for all evaluations. The data will be checked for the normal distribution prior to analysis

The statistical package for social sciences (SPSS) version 25.0 or above for Windows (IBM SPSS version 25.0 or above), NY, USA will be used for the data analysis.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2019
Actual
7/10/2019
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
30/12/2020
Actual
Sample size
Target
30
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 10513 0
New Zealand
State/province [1] 10513 0
Dunedin/ Otago

Funding & Sponsors
Funding source category [1] 299580 0
University
Name [1] 299580 0
School of Physiotherapy, University of Otago
Country [1] 299580 0
New Zealand
Primary sponsor type
Individual
Name
Suranga Dassanayake
Address
School of Physiotherapy, University of Otago, 325, Great King Street, Dunedin North (9016), New Zealand
Country
New Zealand
Secondary sponsor category [1] 298895 0
Individual
Name [1] 298895 0
Margot Skinner
Address [1] 298895 0
School of Physiotherapy, University of Otago, 325, Great King Street, Dunedin North (9016), New Zealand
Country [1] 298895 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300482 0
Health and Disability Ethics Committee, Ministry of Health
Ethics committee address [1] 300482 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 300482 0
New Zealand
Date submitted for ethics approval [1] 300482 0
10/12/2018
Approval date [1] 300482 0
21/12/2018
Ethics approval number [1] 300482 0
18/CEN/257

Summary
Brief summary
The exact prevalence of the condition resistant hypertension (RHT), a subset of hypertension, is unknown in the New Zealand population. Breath pauses during sleep, caused by upper airway closure, (Obstructive sleep apnoea, (OSA)) is a known cause of hypertension but often remains undiagnosed. Physical inactivity is an important modifiable factor for RHT and OSA. However, the influence on blood pressure of an increase in the level of physical activity and thus cardiovascular function has not previously been investigated in the subset with RHT and OSA.

The study is a single group nonrandomized feasibility trial. The main aim of the study is to determine the feasibility of a study to investigate the effectiveness of a 12-week aerobic and strengthening exercise rehabilitation programme, on 24h ambulatory blood pressure (24hABPM), in adults with true RHT (TRHT) and OSA. The target population will be Dunedin based adults, 60 years or younger with TRHT and risk of OSA.

The secondary aims are to investigate the effects of the exercise programme on the level of activity, sleep parameters, structural and functional features of the heart, anthropometrics, level of cardiorespiratory fitness and health-related quality of life. This study is an extension of Study I of the planned PhD project: ‘The prevalence of true resistant hypertension in Dunedin based adults with RHT and the association between TRHT and OSA risk’. The study I has been registered with the Australia New Zealand Clinical Trial Registry (ACTRN12618001110279p) and approved by the Health and Disability Ethics Committee (Ethics Ref: 18/CEN/141). Dunedin based adults 60 years or younger, with TRHT and high risk of OSA will be identified by the research team and invited to participate in Study II.

The change in 24h ambulatory blood pressure will be the key outcome measure. Level of physical activity and sleep fragmentation (using sleep and activity monitoring), the structural and functional measurements of the heart including left ventricular ejection fraction, left ventricular mass (using ultrasound scanning - echocardiogram), BMI, waist to hip ratio, cardiorespiratory fitness and quality of life will be secondary outcome measures.

This research will target the use of prescribed exercise as a non-pharmacological intervention to positively influence blood pressure, in the management of adults with TRHT and OSA. Further, the research will potentially be the first such study in New Zealand, to adhere to the new guidelines for high blood pressure and use 24-hour blood pressure monitoring to determine participants with THRT. The findings have potential to change the direction of thinking in the area, in regard to the non-pharmacological management of RHT and will open the topic of TRHT to more debate and support modified guidelines for physicians and physiotherapists in managing the subpopulation with OSA and TRHT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83798 0
Mr Suranga Dassanayake
Address 83798 0
School of Physiotherapy, University of Otago
325, Great King Street,
Dunedin North. 9016
Country 83798 0
New Zealand
Phone 83798 0
+64 224976151
Fax 83798 0
Email 83798 0
[email protected]
Contact person for public queries
Name 83799 0
Mr Suranga Dassanayake
Address 83799 0
School of Physiotherapy, University of Otago
325, Great King Street,
Dunedin North. 9016
Country 83799 0
New Zealand
Phone 83799 0
+64 224976151
Fax 83799 0
Email 83799 0
[email protected]
Contact person for scientific queries
Name 83800 0
Dr Margot Skinner
Address 83800 0
School of Physiotherapy, University of Otago
325, Great King Street,
Dunedin North. 9016
Country 83800 0
New Zealand
Phone 83800 0
+64 34797466
Fax 83800 0
Email 83800 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
The conclusions will be based on the statistical parameters. The individual data will be provided the relevant participant only. Publishing individual data will not support or affect the targeted outcomes of the study. Further publishing those data will not cause any impact on the society or the field of research.


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23635Informed consent form    375185-(Uploaded-02-12-2020-07-51-01)-Study-related document.pdf
23636Ethical approval    375185-(Uploaded-02-12-2020-08-02-37)-Study-related document.pdf
23637Other    375185-(Uploaded-02-12-2020-07-57-53)-Study-related document.pdf
23825Other    Participants information sheet

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3842Basic resultsNo 375185-(Uploaded-08-12-2020-07-59-47)-Basic results summary.docx
4079Plain language summaryNo Brief summary of the results of the study. 1. Res... [More Details]
4705Conference abstractNo 375185-(Uploaded-08-12-2020-07-54-37)-Other results publication.docx

Documents added automatically
No additional documents have been identified.