HypertensionNCT06515054
Isometric Exercise for Hypertension
A study testing wall squat and passive stretching in people with Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: Isometric resistance exercises (IREs) have great potential to improve blood pressure (BP) control. Methods: This is a pilot randomized controlled trial that will involve 50 patients with hypertension (HT) who do not meet the current physical activity guidelines defined by the World Health Organization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- wall squat and passive stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Jul 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- pregnancy/breastfeeding
- active malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Mechanisms of Isometric Resistance Exercise to Reduce Blood Pressure in a Chinese Population: a Pilot Randomized-controlled Trial
Background: Isometric resistance exercises (IREs) have great potential to improve blood pressure (BP) control.
Methods: This is a pilot randomized controlled trial that will involve 50 patients with hypertension (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. All patients will be followed up for 24 weeks. 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 rate of recruitment. Secondary outcomes will include BP parameters from 24-hour ambulatory BP monitoring
- Conditions
- Hypertension
- Being tested
- wall squat, 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.
wall squatBehavioural
self-learnt wall squat exercise to be conducted for totally 24 weeks
passive stretchingBehavioural
time-matched passive stretching exercise to be conducted for totally 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| isometric exercise | Experimental | wall squat 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) Receives: Behavioral: wall squat |
| passive stretching | Active comparator | A frequency-matched (3x/week) and time-matched (~14 minutes each session) passive static stretching exercise will be used Receives: Behavioral: passive stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of recruitment
number of people recruited per month
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Blood pressure parameters
24-hour, daytime and nighttime blood pressure from 24-hour ambulatory systolic and diastolic blood pressure measurement
Measured: 24-week after recruitment
Carotid-femoral pulse wave velocity
analysed by applanation tonometry using SphygmoCor (AtCor Medical Pty Ltd) with the accompanying SphygmoCor Software Suite (SphygmoCor System)
Measured: 24-week after recruitment
flow-mediated velocity (FMD)
FMD will be performed using a high-resolution linear artery transducer couple with a software (FMD suite, Quipu, Italy) that automatically detect and measure the brachial artery diameter and will be performed according to international guidelines
Measured: 24-week after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start20 Jul 2024
- Primary completion30 Sep 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (actual)
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
- NCT06515054
- Sponsor's protocol ID
- IRE001
- Status last verified
- Nov 2025
- First submitted
- 15 Jul 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Mechanisms of Isometric Resistance Exercise to Reduce Blood Pressure in a Chinese Population: a Pilot Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT06515054
- Acronym / sponsor ID
- IRE001
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Isometric resistance exercises (IREs) have great potential to improve blood pressure (BP) control.
Methods: This is a pilot randomized controlled trial that will involve 50 patients with hypertension (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. All patients will be followed up for 24 weeks. 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 rate of recruitment. Secondary outcomes will include BP parameters from 24-hour ambulatory BP monitoring
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isometric exercise | Experimental | Behavioral: wall squatwall squat 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 | Active comparator | Behavioral: passive stretchingA frequency-matched (3x/week) and time-matched (~14 minutes each session) passive static stretching exercise will be used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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);
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wall squatself-learnt wall squat exercise to be conducted for totally 24 weeks | Behavioural | isometric exercise |
| passive stretchingtime-matched passive stretching exercise to be conducted for totally 24 weeks | Behavioural | passive stretching |
Primary outcome
rate of recruitment
Time frame: through study completion, an average of 1 year
number of people recruited per month
3 secondary outcomes
Blood pressure parameters
Time frame: 24-week after recruitment
Carotid-femoral pulse wave velocity
Time frame: 24-week after recruitment
flow-mediated velocity (FMD)
Time frame: 24-week after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wall squat and passive stretching in people with Hypertension, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of recruitment (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.