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

  • Clinicaltrials.gov identifier

    NCT03923907

  • Recruitment Status

    Not yet recruiting

  • First Posted

    April 23, 2019

  • Last update posted

    January 28, 2021

Study Description

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.

  • Condition or Disease:Hypertension
  • Intervention/Treatment: Behavioral: EIM intervention group
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 198 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • 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 2021
  • Estimated Primary Completion Date: September 2023
  • Estimated Study Completion Date: December 2023

Arms and interventions

Arm Intervention/treatment
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.
Behavioral: EIM intervention group
As in arm description

Outcome Measures

  • Primary Outcome Measures: 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 Outcome Measures: 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

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Kam Pui Lee, MSc 2252 8562 lkp032@cuhk.edu.hk

Locations

Hong Kong
Lek Yuen Clinic
Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

More Information