Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension

ConditionAtherosclerosis Cardiovascular Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorChinese University of Hong Kong

About this trial

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 atherogenesis surrogates (brachial flow-mediated dilation, FMD and carotid intima-media thickness IMT).

(ii) To evaluate the impact of IRE on mechanisms of atherogenesis improvement, inflammatory parameters, arterial wall stiffness and biochemical profiles.

Setting:

Randomized samples of 200 HT patients, aged \>18years 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 for 1 year.

Main outcome measures:

1. Brachial FMD and carotid IMT at baseline, 24 weeks and 1 year. (primary outcome) 2. Carotid-femoral pulse wave velocity (cf-PWV) at baseline and 24 weeks. (secondary outcome) 3. 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). (secondary outcome) 4. Safety profiles (if any) including CVS event and hospitalization at 1 year.

Expected results:

A group absolute difference in FMD of 1%, and in carotid IMT of 0.06mm between IRE intervention and control groups.

Implications: IRE as suggested will be beneficial to management of HT for atherosclerosis preventions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

asymptomatic clinically stable adults

aged >18 years

Both genders

Suboptimal BP (on stable medication) with SBP 135-160mmHG on ambulatory BP monitoring (AMBP)

Disqualifiers

relative contraindications to AMBP (e.g. atrial fibrillation)

severe osteoarthritis of knee

known secondary HT

pregnancy/breastfeeding

Trial design

Design model

Parallel

Treatments tested in this trial

Squatting Exercise
Other intervention
14 minutes per session (2 mins x 4 sets, 2 mins rest in between, 3 session per week)
Stretching (Yoga) Exercise
Other intervention
2 mins x 4 sets, 2 mins rest in between, 3 sessions per week

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Anti HT + Isometric Resistance Squatting Exercise (100 Adults)Active comparator 1 intervention

Group B: Anti HT + Stretching Exercise (100 Adults)Active comparator 1 intervention