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Complex Exercise Intervention to Normalize Blood Pressure and Nocturnal Dipping in Patients With Hypertension (END-HT)

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
EIM intervention group
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lek Yuen ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EIM group

usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

daytime, night-time, 24-h SBP, and DBP
as detected on ABPM discussed above
serum lipid profile
this includes serum total cholesterol, triglyceride , low-density lipoprotein and high-density lipoprotein
body mass index
weight and height will be combined to report BMI in kg/m^2
office blood pressure
office blood pressure will be measured 3 times and the last 2 will be averaged as the outcome
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
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)
body fat percentage
body fat percentage
serum fasting glucose level
serum fasting glucose level
serum creatinine level
serum creatinine level that reflects renal function
waist circumference
waist circumference
serum high sensitive C-reactive protein
serum high sensitive C-reactive protein that reflect the degree of inflammation
MRI (proton density fat fraction)
MRI liver to detect the degree of liver steatosis
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.
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

Full Information

First Posted
April 16, 2019
Last Updated
February 6, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03923907
Brief Title
Complex Exercise Intervention to Normalize Blood Pressure and Nocturnal Dipping in Patients With Hypertension
Acronym
END-HT
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The statistician will be masked
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EIM group
Arm Type
Experimental
Arm Description
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.
Arm Title
usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EIM intervention group
Intervention Description
As in arm description
Primary Outcome Measure Information:
Title
systolic blood pressure(SBP) dipping status
Description
as defined by a lack of SBP drop of more than 10% during sleep, as detected by ambulatory blood pressure measurements (ABPM)
Time Frame
at 12-week, after the EIM program
Secondary Outcome Measure Information:
Title
daytime, night-time, 24-h SBP, and DBP
Description
as detected on ABPM discussed above
Time Frame
baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
Title
serum lipid profile
Description
this includes serum total cholesterol, triglyceride , low-density lipoprotein and high-density lipoprotein
Time Frame
baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
Title
body mass index
Description
weight and height will be combined to report BMI in kg/m^2
Time Frame
baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
Title
office blood pressure
Description
office blood pressure will be measured 3 times and the last 2 will be averaged as the outcome
Time Frame
baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
Title
The Chinese version of international Physical Activity Questionnaire - short form (IPAQ-SF)
Description
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
Time Frame
baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
Title
systolic blood pressure(SBP) dipping status
Description
as defined by a lack of SBP drop of more than 10% during sleep, as detected by ambulatory blood pressure measurements (ABPM)
Time Frame
measured at baseline and 12 months
Title
body fat percentage
Description
body fat percentage
Time Frame
baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
Title
serum fasting glucose level
Description
serum fasting glucose level
Time Frame
baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
Title
serum creatinine level
Description
serum creatinine level that reflects renal function
Time Frame
baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
Title
waist circumference
Description
waist circumference
Time Frame
baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
Title
serum high sensitive C-reactive protein
Description
serum high sensitive C-reactive protein that reflect the degree of inflammation
Time Frame
baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment
Title
MRI (proton density fat fraction)
Description
MRI liver to detect the degree of liver steatosis
Time Frame
baseline (before the 12 week program), at 12 weeks
Title
Pittsburgh Sleep Quality Index(PSQI)
Description
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.
Time Frame
baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment
Title
STOP-BANG (Snoring, Tiredness, Observed apnea, Blood pressure, Body mass index, Age, Neck circumference and Gender) questionnaire
Description
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
Time Frame
baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kam Pui Lee, MSc
Phone
2252 8562
Email
lkp032@cuhk.edu.hk
Facility Information:
Facility Name
Lek Yuen Clinic
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kam Pui Lee, Msc
Phone
+852 60996560
Email
Lkp032@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Kam pui Lee, Msc

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Will be made available on request from investigators
Citations:
PubMed Identifier
33471104
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.
Results Reference
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Complex Exercise Intervention to Normalize Blood Pressure and Nocturnal Dipping in Patients With Hypertension

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