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NCT Number: NCT06510998

Isometric Resistance Exercise for Hypertension

Background: Isometric resistance exercises (IREs) have great potential to improve blood pressure (BP) control. However, the effectiveness of IREs in reducing HT is still unknown because their hypotensive effects have not been detected using ambulatory BP measurements (ABPM), which are the current standard for BP measurement.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lek Yuen General Outpatient Clinic, Hong Kong

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • a suboptimal daytime SBP of >135-160 mmHg on a 24-h ABPM
  • 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

  • cannot provide informed consent
  • 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

Treatment and study plan

isometric wall exercise

Behavioral

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

Behavioral

A frequency-matched (3x/week) and time-matched (~14 minutes each session) passive static stretching exercise will be used

Primary outcomes

  1. daytime systolic blood pressure (BP) assessed via ambulatory blood pressure monitoring (ABPM)

    Time frame: 24-week after recruitment (immediate post-intervention)

    systolic blood pressure (SBP) measured from a 24-h ABPM

Secondary outcomes

  1. Other blood pressure indices

    Time frame: 24-week, 1 year

    other BP indices from ABPM (i.e. daytime diastolic BP [DBP] at 24-week, daytime SBP/DBP at 1 year, and 24-hour and nighttime SBP and DBP at 24-week and 1 year)

  2. Carotid-femoral pulse wave velocity

    Time frame: 24-week after recruitment (immediate post-intervention), 1 year

    This will be analysed by applanation tonometry using SphygmoCor (AtCor Medical Pty Ltd) with the accompanying SphygmoCor Software Suite (SphygmoCor System

  3. flow-mediated dilation of brachial artery (FMD)

    Time frame: 24-week after recruitment (immediate post-intervention), 1 year

    The longitudinal image of brachial artery is obtained 5-10cm above the elbow using a high frequency linear array vascular transducer XL14 (Philips Medical Systems, Bothell, WA, USA). After a qualified image is acquired for analysis, a pressure cuff placed distal to the imaging probe at the forearm will be inflated to 50mmHg above the systolic pressure for 5 minutes. The longitudinal image of the brachial artery is scan continuous for 3 minutes after the deflation of the cuff. Due to budget limitations, only the first 100 (50 intervention and 50 control) patients with receive FMD

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Kam-Pui Lee, MSc, FRACGP

CONTACT

[email protected]

22528462

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Effectiveness and Mechanisms of Isometric Resistance Exercise to Reduce Blood Pressure in a Chinese Population: a Randomized-controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 19, 2024
Registry last updated
Dec 29, 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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