Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension

NCT07665034 | Recruiting DMC

• 1 other identifier: 2022-618-T
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 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. 2.100 control patients (usual care) with advice on diet and healthy lifestyles and simple stretching exercise programme (yoga) for 1 year.
3. 3.BP - Clinic BP and Ambulatory BP parameters at baseline, 12 weeks and 24 weeks. (primary outcome)
4. 4.Brachial FMD and carotid IMT at baseline, 24 weeks and 1 year. (primary outcome)
5. 5.Carotid-femoral pulse wave velocity (cf-PWV) at baseline and 24 weeks.
6. 6.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).
7. 7.Safety profiles (if any) including CVS event and hospitalization at 1 year.

Conditions

Atherosclerosis Cardiovascular Disease

Keywords

Isometric Resistance Exercise; Essential Hypertension; Atherosclerosis; Brachial FMD; Carotid IMT; Atherosclerosis Prevention

Outcome Measures

Primary Outcomes (3)

• The Impact of Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension

  Changes in Daytime BP monitoring (mmHg)

  Baseline, 24 weeks and 1 year

• The Impact of Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension

  Changes in Brachial FMD (%)

  Baseline, 24 weeks and 1 year

• The Impact of Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension

  Changes in Carotid IMT (mm)

  Baseline, 24 weeks and 1 year

Secondary Outcomes (11)

• The Impact of Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension

  Baseline, 24 weeks and 1 year

• The Impact of Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension

  Baseline and 24 weeks

• The Impact of Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension

  Baseline, 24 weeks and 1 year

• The Impact of Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension

  Baseline, 24 weeks and 1 year

• The Impact of Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension

  Baseline, 24 weeks and 1 year

Study Arms (2)

Anti HT + Isometric Resistance Squatting Exercise (100 Adults)

ACTIVE COMPARATOR

A more linear thigh-leg squatting angle is allowed in initial 2 weeks, but aiming at 90 degree thigh-leg angle after 4 weeks.

Other: Squatting Exercise

Anti HT + Stretching (Yoga) Exercise (100 Adults)

ACTIVE COMPARATOR

A liberal leg stretching excerise will be practised

Other: Stretching (Yoga) Exercise

Interventions

Squatting Exercise OTHER

14 minutes per session (2 mins x 4 sets, 2 mins rest in between, 3 session per week)

Anti HT + Isometric Resistance Squatting Exercise (100 Adults)

Stretching (Yoga) Exercise OTHER

2 mins x 4 sets, 2 mins rest in between, 3 sessions per week

Anti HT + Stretching (Yoga) Exercise (100 Adults)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• asymptomatic clinically stable adults
• aged 18-75 years
• Both genders
• Suboptimal BP (on stable medication) with SBP 135-160mmHG on ambulatory BP monitoring (AMBP)
• Agreeable to no drug changes in coming 1 year 24 weeks
• Agreeable to provide informed written consent form
• Agreeable to have AMBP and ultrasonic (FMD \& IMT) scan third (baseline, 24 weeks and preferably 1 year)

You may not qualify if:

• relative contraindications to AMBP (e.g. atrial fibrillation)
• severe osteoarthritis of knee
• known secondary HT
• pregnancy/breastfeeding
• active malignancy
• Serious coronary profiles, (unstable angina), renal or hepatic derangement
• Need to change medications for control BP at 24 weeks ( SBP\>160 mmHg)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong, Department of Medicine & Therapeutics

Shatin, Hong Kong

RECRUITING

Related Publications (23)

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  BACKGROUND

MeSH Terms

Conditions

Essential Hypertension; Atherosclerosis

Interventions

Yoga; Exercise

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kam Sang Woo

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KS Woo, MBBS, MD, FACC

CONTACT

+852 26474966; kamsangwoo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: June 24, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: These materials will be available and shared on reasonable requests to Prof KS Woo from January 2025 till July 2027
• Access Criteria: These materials will be available and shared on reasonable requests to Prof KS Woo from January 2025 till July 2027 (kamsangwoo@cuhk.edu.hk/ crec@cuhk.edu.hk)

Locations

HK (1)