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.
Condition or disease | Intervention/treatment | Phase |
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Hypertension | Behavioral: EIM intervention group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 198 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Masking Description: | The statistician will be masked |
Primary Purpose: | Treatment |
Official Title: | Effectiveness of a Complex Exercise Intervention to Normalize Blood Pressure and Its Nocturnal Dipping in Patients With HyperTension in Primary Care: a Randomized-controlled Trial |
Estimated Study Start Date : | March 1, 2021 |
Estimated Primary Completion Date : | September 30, 2023 |
Estimated Study Completion Date : | December 31, 2023 |
Arm | Intervention/treatment |
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Experimental: EIM group
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.
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Behavioral: EIM intervention group
As in arm description
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No Intervention: usual care
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.
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Occupational drivers - because they need to hold their arm still during ABPM and this may be hazardous for drivers
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
Contact: Kam Pui Lee, MSc | 2252 8562 | lkp032@cuhk.edu.hk |
Hong Kong | |
Lek Yuen Clinic | |
Hong Kong, Hong Kong |
Tracking Information | |||||
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First Submitted Date ICMJE | April 16, 2019 | ||||
First Posted Date ICMJE | April 23, 2019 | ||||
Last Update Posted Date | January 28, 2021 | ||||
Estimated Study Start Date ICMJE | March 1, 2021 | ||||
Estimated Primary Completion Date | September 30, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
systolic blood pressure(SBP) dipping status [ Time Frame: 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)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Complex Exercise Intervention to Normalize Blood Pressure and Nocturnal Dipping in Patients With Hypertension | ||||
Official Title ICMJE | Effectiveness of a Complex Exercise Intervention to Normalize Blood Pressure and Its Nocturnal Dipping in Patients With HyperTension in Primary Care: a Randomized-controlled Trial | ||||
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. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Masking Description: The statistician will be masked Primary Purpose: Treatment
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Condition ICMJE | Hypertension | ||||
Intervention ICMJE | Behavioral: EIM intervention group
As in arm description
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Study Arms ICMJE |
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Publications * | Lee EKP, Zhang DX, Yip BHK, Cheng J, Hui SSC, Yu YTE, Leung M, Chu WCW, Milhailidou AS, Wong SYS. Exercise intervention to Normalize blood pressure and nocturnal Dipping in HyperTensive patients (END-HT): protocol of a randomized controlled trial. Am J Hypertens. 2021 Jan 20. pii: hpab019. doi: 10.1093/ajh/hpab019. [Epub ahead of print] | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
198 | ||||
Original Estimated Enrollment ICMJE |
174 | ||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||
Estimated Primary Completion Date | September 30, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Hong Kong | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03923907 | ||||
Other Study ID Numbers ICMJE | NTEC-2019-0264 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Lee Kam Pui, Chinese University of Hong Kong | ||||
Study Sponsor ICMJE | Chinese University of Hong Kong | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Chinese University of Hong Kong | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |