None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
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