Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
390 participants
INTERVENTIONAL
2025-01-01
2027-09-28
Brief Summary
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Methods: This first adequately-powered RCT will involve 390 patients with HT who do not meet the current physical activity guidelines defined by the World Health Organization. Participants will be randomly assigned in a 1:1 ratio using stratified and blocked randomization to either the IRE (wall squat) group or stretching exercise (active control) group. A well-structured, widely accepted, and validated 24-week wall squat program (2 minutes per exercise, 2 minutes of rest between sets, and 3 sessions per week) will be implemented, as it has been commonly used in previous research. Adherence to the program will be monitored using smartwatches, and regular contact with patients through social media will help ensure adherence. All patients will be followed up for 1 year to investigate the long-term effects of IREs on BP. Control group will receive exact same treatment except that IRE is replaced by frequency-matched and time-matched stretching exercise. The primary outcome measure will be systolic daytime ABPM BP at 24 weeks. Secondary outcome measures will include other BP and ABPM parameters at 12 weeks, 24weeks and 1year, cfPWV at baseline, 24 weeks and 1year, and FMD at baseline and 24weeks. Safety data will be collected and reported.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Isometric exercise
2 minutes wall squat, with 2 minutes rest between sets
* to perform 4 sets in total/day
* at least 3 days/week
* totally for 24-weeks
isometric wall exercise
Each exercise session will contain 4 sets of 2-minute wall squat isometric holds with 2 minutes of rest between each set (approximately 14 minutes per session in total), and a total of 3 sessions will be arranged every week (with ideally 48 h between exercises)
passive stretching
14 minutes passive stretching
* at least 3 days/week
* totally 24-weeks
passive stretching
A frequency-matched (3x/week) and time-matched (\~14 minutes each session) passive static stretching exercise will be used
Interventions
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isometric wall exercise
Each exercise session will contain 4 sets of 2-minute wall squat isometric holds with 2 minutes of rest between each set (approximately 14 minutes per session in total), and a total of 3 sessions will be arranged every week (with ideally 48 h between exercises)
passive stretching
A frequency-matched (3x/week) and time-matched (\~14 minutes each session) passive static stretching exercise will be used
Eligibility Criteria
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Inclusion Criteria
* reported no regular physical activity or less than that recommended for adults by the World Health Organization (e.g. \<150 minutes of moderate-intensity aerobic exercise per week)
* on stable doses of anti-HT medication(s) for ≥4 weeks if the patient is receiving drug treatments;
* agree for no drug changes during the intervention period (24 weeks);
Exclusion Criteria
* unwillingness to repeat ABPM
* relative contraindications to ABPM (i.e. diagnosed atrial fibrillation, nighttime workers, occupational drivers, or patients with bleeding tendencies)
* severe osteoarthritis pending knee replacement surgery
* known secondary HT
* use of ≥3 anti-HT medications at maximum doses or ≥4 anti-HT medications
* SBP or DBP are \>160 mmHg or \>100 mmHg, respectively, on ABPM at baseline or at 12 weeks follow-up to ensure safety
* pregnancy/breastfeeding
* active malignancy
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Lee Kam Pui
clinical associate professor
Locations
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Lek Yuen General Outpatient Clinic
Hong Kong, , Hong Kong
School of public health and primary care
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Eric Kam-Pui Prof Lee
Role: primary
kam pui Lee, Msc
Role: primary
Other Identifiers
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2022.618
Identifier Type: -
Identifier Source: org_study_id