Isometric Resistance Exercise for Hypertension

NCT06510998 | Recruiting

• 1 other identifier: 2022.618
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 2

Brief 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 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

Outcome Measures

Primary Outcomes (1)

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

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

  24-week after recruitment (immediate post-intervention)

Secondary Outcomes (3)

• Other blood pressure indices

  24-week, 1 year

• Carotid-femoral pulse wave velocity

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

• flow-mediated dilation of brachial artery (FMD)

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

Study Arms (2)

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

Behavioral: isometric wall exercise

passive stretching

ACTIVE COMPARATOR

14 minutes passive stretching * at least 3 days/week * totally 24-weeks

Behavioral: passive stretching

Interventions

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)

Isometric exercise

passive stretching BEHAVIORAL

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

passive stretching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Lek Yuen General Outpatient Clinic

Hong Kong, 00000, Hong Kong

RECRUITING

School of public health and primary care

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Eric Kam-Pui Lee, MSc, FRACGP

CONTACT

22528462; lkp032@cuhk.edu.hk

Study Design

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

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 28, 2027
• Study Completion (Estimated): September 28, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

HK (2)