NCT07665034 Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
| NCT ID | NCT07665034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Atherosclerosis Cardiovascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-10-15 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Hypertension (HT) is the most common condition worldwide, predisposing to atherosclerotic disease. However, most HT patients have suboptimal BP control despite anti-HT medications. Isometric resistance exercise (IRE) (e.g. wall squat) may improve BP control, characterized by sustained muscle contraction with minimal change in muscle length and joint angle. Most randomized trials of IRE are short duration and their long-term effects on BP and atherosclerotic complications, particularly in the Chinese, remain unknown. Study objectives: (i) To evaluate the impact of IRE on Clinic and Ambulatory BP (AMBP) in Hong Kong Chinese. (ii) To evaluate the impact of IRE on atherogeneisis surrogates (brachial flow-mediated dilation, FMD and carotid intima-media thickness IMT). (iii) To evaluate the impact of IRE on mechanisms of BP reduction, including endothelial function FMD, carotid IMT, inflammatory parameters and arterial wall stiffness (cfPWV). Setting: Randomized samples of 200 HT patients, aged 18-75 years with systolic BP 135-160mHg while on no or stable anti-HT medications. Design: Randomized controlled IRE trial - stratified randomization with randomization block size of 4. 1. 100 patients for wall squat exercise of 14 mins each session (2 mins IRE x 4 sets, 2 mins rest in between), 3 sessions per week, for 1 year, plus advice on healthy diet and lifestyle. 2. 100 control patients (usual care) with advice on diet and healthy lifestyles and simple stretching exercise programme (yoga) for 1 year. All patients will be invited to continue their exercise programme and return for follow up FMD and carotid IMT at 24 weeks and 1 year, and PWV at 24 weeks. Main outcome measures: 1. BP - Clinic BP and Ambulatory BP parameters at baseline, 12 weeks and 24 weeks. (primary outcome) 2. Brachial FMD and carotid IMT at baseline, 24 weeks and 1 year. (primary outcome) 3. Carotid-femoral pulse wave velocity (cf-PWV) at baseline and 24 weeks. 4. Important atherosclerosis risk factor parameters at baseline, 24 weeks and 1 year - including fasting serum glucose, lipid profiles, HgbA1-C, creatinine, hs-CRP, CBP, fibrinogen, and interleukin 6 (IL-6). 5. Safety profiles (if any) including CVS event and hospitalization at 1 year. Expected results: IRE Intervention versus control group, (i) 3mHg more reduction in SBP (Clinic and AMBP). (ii) A group absolute difference in FMD of 1%, and in carotid IMT of 0.06mm between the 2 treatment groups. Implications: IRE as suggested will be beneficial to management of HT, and will be of great importance in health care of this common disorder in both primary and secondary preventions of atherosclerosis diseases.
Eligibility Criteria
Inclusion Criteria: 1. asymptomatic clinically stable adults 2. aged 18-75 years 3. Both genders 4. Suboptimal BP (on stable medication) with SBP 135-160mmHG on ambulatory BP monitoring (AMBP) 5. Agreeable to no drug changes in coming 1 year 24 weeks 6. Agreeable to provide informed written consent form 7. Agreeable to have AMBP and ultrasonic (FMD \& IMT) scan third (baseline, 24 weeks and preferably 1 year) Exclusion Criteria: 1. relative contraindications to AMBP (e.g. atrial fibrillation) 2. severe osteoarthritis of knee 3. known secondary HT 4. pregnancy/breastfeeding 5. active malignancy 6. Serious coronary profiles, (unstable angina), renal or hepatic derangement 7. Need to change medications for control BP at 24 weeks ( SBP\>160 mmHg)
Contact & Investigator
Kam Sang Woo
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT07665034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Atherosclerosis Cardiovascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07665034 currently recruiting?
Yes, NCT07665034 is actively recruiting participants. Contact the research team at kamsangwoo@cuhk.edu.hk for enrollment information.
Where is the NCT07665034 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT07665034 clinical trial?
NCT07665034 is sponsored by Chinese University of Hong Kong. The principal investigator is Kam Sang Woo at Chinese University of Hong Kong. The trial plans to enroll 200 participants.