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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EIM group | Experimental | patients with Hypertension (HT) will be recruited by a trained nurse when the patient attends the yearly to bi-yearly complication screening program called the risk assessment and management program (RAMP) program. This program is provided to all patients with HT, who are seen in the Government-funded primary care clinics in Hong Kong. The nurse will encourage the patient by motivational interviewing techniques and prescribe exercise. Combined exercise skills will be taught in the 12-week weekly exercise classes by certified physical trainers. Peer support is encouraged during and after the 12-week program. Regular feedback, prompting and problem solving will be provided by the nurse at 3m, 6m, and 12m. Exercise level will be monitored by validated wrist trackers to feedback participants, nurse and physical trainer by mobile apps and website. Resources to exercise will be made known to patients by apps, website and healthcare professionals. |
|
| usual care | No Intervention | There is no extra intervention to patients allocated in this arm, except that they receive information and advice on lifestyle changes including benefits from exercise from the nurse at recruitment as stated above. Participants in both arms will have no changes in medication within the first 12-week to determine the BP difference between the two groups. In Hong Kong, patients have unlimited access to emergency department and general outpatient services. All patients with HT receive RAMP program counselling and screening every 1-2 years. These are not limited by the current trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EIM intervention group | Behavioral | As in arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| systolic blood pressure(SBP) dipping status | as defined by a lack of SBP drop of more than 10% during sleep, as detected by ambulatory blood pressure measurements (ABPM) | at 12-week, after the EIM program |
| Measure | Description | Time Frame |
|---|---|---|
| daytime, night-time, 24-h SBP, and DBP | as detected on ABPM discussed above | baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment |
| serum lipid profile | this includes serum total cholesterol, triglyceride , low-density lipoprotein and high-density lipoprotein |
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Inclusion Criteria:
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
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.
To maximize safety of patients, patients who are relatively contraindicated according to AHA will also be excluded
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lek Yuen Clinic | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33471104 | Background | Lee EK, Zhang DD, Yip BH, Cheng J, Hui SS, Yu EYT, Leung M, Chu WCW, Mihailidou AS, Wong SY. Exercise Intervention to Normalize Blood Pressure and Nocturnal Dipping in HyperTensive Patients (END-HT): Protocol of a Randomized Controlled Trial. Am J Hypertens. 2021 Aug 9;34(7):753-759. doi: 10.1093/ajh/hpab019. |
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Will be made available on request from investigators
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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The statistician will be masked
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| baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment |
| body mass index | weight and height will be combined to report BMI in kg/m^2 | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment |
| office blood pressure | office blood pressure will be measured 3 times and the last 2 will be averaged as the outcome | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment |
| The Chinese version of international Physical Activity Questionnaire - short form (IPAQ-SF) | 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 | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment |
| systolic blood pressure(SBP) dipping status | as defined by a lack of SBP drop of more than 10% during sleep, as detected by ambulatory blood pressure measurements (ABPM) | measured at baseline and 12 months |
| body fat percentage | body fat percentage | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment |
| serum fasting glucose level | serum fasting glucose level | baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment |
| serum creatinine level | serum creatinine level that reflects renal function | baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment |
| waist circumference | waist circumference | baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment |
| serum high sensitive C-reactive protein | serum high sensitive C-reactive protein that reflect the degree of inflammation | baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment |
| MRI (proton density fat fraction) | MRI liver to detect the degree of liver steatosis | baseline (before the 12 week program), at 12 weeks |
| Pittsburgh Sleep Quality Index(PSQI) | 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. | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment |
| STOP-BANG (Snoring, Tiredness, Observed apnea, Blood pressure, Body mass index, Age, Neck circumference and Gender) questionnaire | 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 | baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment |