HypertensionNCT06510998
Isometric Resistance Exercise for Hypertension
A study testing isometric wall exercise and passive stretching in people with Hypertension, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- isometric wall exercise and passive stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Jan 2025to 28 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Recruiting
Lek Yuen General Outpatient Clinic
Hong Kong, 00000
Eric Kam-Pui Prof Lee, 22528462, lkp032@cuhk.edu.hk
- Recruiting
School of public health and primary care
Hong Kong
kam pui Lee, Msc, 85260996560, lkp032@cuhk.edu.hk
About this study
Official title: Effectiveness and Mechanisms of Isometric Resistance Exercise to Reduce Blood Pressure in a Chinese Population: a Randomized-controlled Trial
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.
- Conditions
- Hypertension
- Being tested
- isometric wall exercise, passive stretching
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isometric wall exerciseBehavioural
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 stretchingBehavioural
A frequency-matched (3x/week) and time-matched (~14 minutes each session) passive static stretching exercise will be used
| Study group | Role | What they receive |
|---|---|---|
| Isometric exercise | Experimental | 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 Receives: Behavioral: isometric wall exercise |
| passive stretching | Active comparator | 14 minutes passive stretching
* at least 3 days/week
* totally 24-weeks Receives: Behavioral: passive stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
daytime systolic blood pressure (BP) assessed via ambulatory blood pressure monitoring (ABPM)
systolic blood pressure (SBP) measured from a 24-h ABPM
Measured: 24-week after recruitment (immediate post-intervention)
Secondary outcomes (3)
Other blood pressure indices
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)
Measured: 24-week, 1 year
Carotid-femoral pulse wave velocity
This will be analysed by applanation tonometry using SphygmoCor (AtCor Medical Pty Ltd) with the accompanying SphygmoCor Software Suite (SphygmoCor System
Measured: 24-week after recruitment (immediate post-intervention), 1 year
flow-mediated dilation of brachial artery (FMD)
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
Measured: 24-week after recruitment (immediate post-intervention), 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Jan 2025
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Kam Pui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510998
- Sponsor's protocol ID
- 2022.618
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ng SN, Yip BH, Sit RW, Woo KS, Wang S, Cohen DD, Lopez-Jaramillo P, Persu A, Tan GM, Cornelissen V, Pyun WB, Camafort BM, Wong SY, Lee EK. Effectiveness and mechanisms of isometric resistance exercise to reduce blood pressure in a Chinese population: study protocol for a randomized-controlled trial. Trials. 2026 Jun 3. doi: 10.1186/s13063-026-09798-x. Online ahead of print.
PubMed 42237351