Hypertension
Conditions
Brief summary
Background: Non-dipping hypertension(HT) (as defined by lack of decrease in systolic blood pressure (BP) by 10% during sleep) predicts cardiovascular events and mortality; however, there is a lack of evidence based treatment for non-dipping HT. While exercise is recommended to management HT, its effect on dipping status is not known. There is a lack of trials describing the relationship of exercise and blood pressure in Chinese. Method: This will be a two-arm randomized controlled trial in which Chinese non-dippers (n= 198) will be randomized to an exercise program plus usual care or to usual care by stratified randomization. The randomization sequence is blinded to the investigators and allocation is disclosed only after valid consent. The exercise program utilizes various motivational techniques to enhance exercise maintenance.
Interventions
BEHAVIORALEIM intervention group
As in arm description
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The statistician will be masked
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* SBP non-dippers * self-reported exercise intensity and duration less than the World Health Organization recommendation, which is exercise of moderate intensity less than 150minutes/week OR exercise of vigorous intensity of less than 75 minutes/week * Used any mobile apps on their phone (because the intervention involve use of apps to monitor and remind regular exercise)
Exclusion criteria
* Patients with diagnosed chronic obstructive lung disease and recent stroke (within last 12 months) because other evidence-proven and well-structured programmes are implemented for these patients in the hospital authority in Hong Kong * Occupational drivers - because they need to hold their arm still during ABPM and this may be hazardous for drivers * night-time workers * diagnosed Obstructive Sleep Apnea * Patients on anti-coagulants - because ABPM may induce bruises * Patients on 3 or more medications for hypertension (on maximum tolerable doses) - these patients may have secondary HT and represent a different spectrum of organic diseases * Patients with SBP \>180mmHg or DBP \>110mmHg - drug titration is not allowed during the 12-week program and these patients need early drug treatment * Patient with DM - these patients will be arranged to have another EIM program especially designed for their DM. * Patients with active spinal cord compression or spinal radiculopathy because they may not be suitable to join some exercise * patients with atrial fibrillation are excluded because these patients have increased BP variability and may have different dipping behaviour * patients with metallic implants or pacemakers are excluded as they are not suitable for MRI * To maximize safety of patients, patients who are relatively contraindicated according to AHA will also be excluded * acute myocardial infarction in last 6 months * ongoing angina * uncontrolled cardiac arrhythmia * acute diseases including known active endocarditis/acute pulmonary embolism, pulmonary infarction, deep vein thrombosis, acute aortic dissection, acute myocarditis * known aortic stenosis * known heart failure * known obstructive left main coronary artery stenosis * uncontrolled ventricular rates * complete heart block * known hypertrophic obstructive cardiomyopathy * mental impairment that limit co-operation * resting blood pressure with systolic blood pressure \>180mmHg or diastolic blood pressure \>110mmHg * known anemia with hemoglobin level less than 11gm/dL * known uncorrected electrolyte imbalance, and * known uncontrolled hyperthyroidism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| systolic blood pressure(SBP) dipping status | at 12-week, after the EIM program | as defined by a lack of SBP drop of more than 10% during sleep, as detected by ambulatory blood pressure measurements (ABPM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum lipid profile | baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment | this includes serum total cholesterol, triglyceride , low-density lipoprotein and high-density lipoprotein |
| body mass index | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment | weight and height will be combined to report BMI in kg/m\^2 |
| office blood pressure | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment | office blood pressure will be measured 3 times and the last 2 will be averaged as the outcome |
| The Chinese version of international Physical Activity Questionnaire - short form (IPAQ-SF) | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment | a validated questionnaire to detect exercise level; The questionnaire can provide the amount of time the participant spend on moderate or vigorous physical activities. The amount of energy spent can be calculated (metabolic equivalent of task; MET). For example, high level of exercise can be defined as a minimum total physical activity of at least 3000 MET minutes a week. The higher the MET, the higher the exercise level |
| systolic blood pressure(SBP) dipping status | measured at baseline and 12 months | as defined by a lack of SBP drop of more than 10% during sleep, as detected by ambulatory blood pressure measurements (ABPM) |
| body fat percentage | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment | body fat percentage |
| daytime, night-time, 24-h SBP, and DBP | baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment | as detected on ABPM discussed above |
| serum creatinine level | baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment | serum creatinine level that reflects renal function |
| waist circumference | baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment | waist circumference |
| serum high sensitive C-reactive protein | baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment | serum high sensitive C-reactive protein that reflect the degree of inflammation |
| MRI (proton density fat fraction) | baseline (before the 12 week program), at 12 weeks | MRI liver to detect the degree of liver steatosis |
| Pittsburgh Sleep Quality Index(PSQI) | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment | a validated questionnaire to detect sleep quality; possible global score include can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. |
| STOP-BANG (Snoring, Tiredness, Observed apnea, Blood pressure, Body mass index, Age, Neck circumference and Gender) questionnaire | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment | a validated questionnaire to detect presence of sleep apnea; any 3 positive items from the 8 questions as having risk of OSA; the higher the number of positive items, the higher the risk |
| serum fasting glucose level | baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment | serum fasting glucose level |
Countries
Hong Kong
Outcome results
None listed