HypertensionEND-HTNCT03923907
Complex Exercise Intervention to Normalize Blood Pressure and Nocturnal Dipping in Patients With Hypertension
A study testing EIM intervention group in people with Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- EIM intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Sep 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hypertension
- Being tested
- EIM intervention group
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIM intervention groupBehavioural
As in arm description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: EIM intervention group |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 12-week, after the EIM program
Secondary outcomes (14)
daytime, night-time, 24-h SBP, and DBP
as detected on ABPM discussed above
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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: measured at baseline and 12 months
body fat percentage
body fat percentage
Measured: 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
Measured: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
serum creatinine level
serum creatinine level that reflects renal function
Measured: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
waist circumference
waist circumference
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start15 Sep 2021
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Kam Pui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923907
- Sponsor's protocol ID
- NTEC-2019-0264
- Acronym
- END-HT
- Status last verified
- Dec 2025
- First submitted
- 16 Apr 2019
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be made available on request from investigators
Publications
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.
PubMed 33471104
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03923907
- Acronym / sponsor ID
- END-HT / NTEC-2019-0264
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIM group | Experimental | Behavioral: EIM intervention grouppatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EIM intervention groupAs in arm description | Behavioural | EIM group |
Primary outcome
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)
14 secondary outcomes
daytime, night-time, 24-h SBP, and DBP
Time frame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
serum lipid profile
Time frame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
body mass index
Time frame: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
office blood pressure
Time frame: 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)
Time frame: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
systolic blood pressure(SBP) dipping status
Time frame: measured at baseline and 12 months
body fat percentage
Time frame: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
serum fasting glucose level
Time frame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
serum creatinine level
Time frame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
waist circumference
Time frame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
serum high sensitive C-reactive protein
Time frame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
MRI (proton density fat fraction)
Time frame: baseline (before the 12 week program), at 12 weeks
Pittsburgh Sleep Quality Index(PSQI)
Time frame: 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
Time frame: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 33471104Lee 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.
- Individual participant dataSharing planned: Undecided. Will be made available on request from investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIM intervention group in people with Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure(SBP) dipping status (time frame: at 12-week, after the EIM program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03923907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.