Clinical trial NCT03923907: Complex Exercise Intervention to Normalize Blood Pressure and Nocturnal Dipping in Patients With Hypertension
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: systolic blood pressure(SBP) dipping status
timeFrame: at 12-week, after the EIM program
Secondary outcomes:
measure: daytime, night-time, 24-h SBP, and DBP
timeFrame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
measure: serum lipid profile
timeFrame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
measure: body mass index
timeFrame: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
measure: office blood pressure
timeFrame: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
measure: The Chinese version of international Physical Activity Questionnaire - short form (IPAQ-SF)
timeFrame: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
measure: systolic blood pressure(SBP) dipping status
timeFrame: measured at baseline and 12 months
measure: body fat percentage
timeFrame: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
measure: serum fasting glucose level
timeFrame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
measure: serum creatinine level
timeFrame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
measure: waist circumference
timeFrame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
measure: serum high sensitive C-reactive protein
timeFrame: baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
measure: MRI (proton density fat fraction)
timeFrame: baseline (before the 12 week program), at 12 weeks
measure: Pittsburgh Sleep Quality Index(PSQI)
timeFrame: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
measure: STOP-BANG (Snoring, Tiredness, Observed apnea, Blood pressure, Body mass index, Age, Neck circumference and Gender) questionnaire
timeFrame: baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Lek Yuen Clinic
Study officials:
References:
citation: 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.