- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06515054
Isometric Exercise for Hypertension
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- School of public health and primary care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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)
|
self-learnt wall squat exercise to be conducted for totally 24 weeks
|
|
Active Comparator: passive stretching
A frequency-matched (3x/week) and time-matched (~14 minutes each session) passive static stretching exercise will be used
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time-matched passive stretching exercise to be conducted for totally 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
rate of recruitment
Time Frame: through study completion, an average of 1 year
|
number of people recruited per month
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure parameters
Time Frame: 24-week after recruitment
|
24-hour, daytime and nighttime blood pressure from 24-hour ambulatory systolic and diastolic blood pressure measurement
|
24-week after recruitment
|
|
Carotid-femoral pulse wave velocity
Time Frame: 24-week after recruitment
|
analysed by applanation tonometry using SphygmoCor (AtCor Medical Pty Ltd) with the accompanying SphygmoCor Software Suite (SphygmoCor System)
|
24-week after recruitment
|
|
flow-mediated velocity (FMD)
Time Frame: 24-week after recruitment
|
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
|
24-week after recruitment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Hypertension
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise
- Muscle Stretching Exercises
Other Study ID Numbers
- IRE001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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