Effectiveness and Mechanisms of Isometric Resistance Exercise to Reduce Blood Pressure in a Chinese Population: a Pilot Randomized-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- rate of recruitment
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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);
Exclusion Criteria
- •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
- •pregnancy/breastfeeding
- •active malignancy
Arms & Interventions
passive stretching
A frequency-matched (3x/week) and time-matched (~14 minutes each session) passive static stretching exercise will be used
Intervention: passive stretching (Behavioral)
isometric exercise
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)
Intervention: wall squat (Behavioral)
Outcomes
Primary Outcomes
rate of recruitment
Time Frame: through study completion, an average of 1 year
number of people recruited per month
Secondary Outcomes
- Blood pressure parameters(24-week after recruitment)
- flow-mediated velocity (FMD)(24-week after recruitment)
- Carotid-femoral pulse wave velocity(24-week after recruitment)
Investigators
Lee Kam Pui
clinical associate professor
Chinese University of Hong Kong