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Completed

NCT Number: NCT03923907

Complex Exercise Intervention to Normalize Blood Pressure and Nocturnal Dipping in Patients With Hypertension

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lek Yuen Clinic

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EIM intervention group

Behavioral

As in arm description

Primary outcomes

  1. 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)

Secondary outcomes

  1. daytime, night-time, 24-h SBP, and DBP

    Time frame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment

    as detected on ABPM discussed above

  2. serum lipid profile

    Time frame: 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

  3. body mass index

    Time frame: 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

  4. office blood pressure

    Time frame: 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

  5. 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

    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

  6. systolic blood pressure(SBP) dipping status

    Time frame: 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)

  7. body fat percentage

    Time frame: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment

    body fat percentage

  8. serum fasting glucose level

    Time frame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment

    serum fasting glucose level

  9. serum creatinine level

    Time frame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment

    serum creatinine level that reflects renal function

  10. waist circumference

    Time frame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment

    waist circumference

  11. serum high sensitive C-reactive protein

    Time frame: 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

  12. MRI (proton density fat fraction)

    Time frame: baseline (before the 12 week program), at 12 weeks

    MRI liver to detect the degree of liver steatosis

  13. Pittsburgh Sleep Quality Index(PSQI)

    Time frame: 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.

  14. 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

    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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Acronym: END-HT

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2019
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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