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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]

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

Obstructive sleep apnoea

Condition category

Condition code

Cardiovascular

Hypertension

Respiratory

Sleep apnoea

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline and 12 weeks after intervention commencement.

Secondary outcome [1]

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]