Complex Exercise Intervention to Normalize Blood Pressure and Nocturnal Dipping in Patients With Hypertension

NCT03923907 | Completed DMC

• 1 other identifier: NTEC-2019-0264
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Non-dipping hypertension(HT) (as defined by lack of decrease in systolic blood pressure (BP) by 10% during sleep) predicts cardiovascular events and mortality; however, there is a lack of evidence based treatment for non-dipping HT. While exercise is recommended to management HT, its effect on dipping status is not known. There is a lack of trials describing the relationship of exercise and blood pressure in Chinese. Method: This will be a two-arm randomized controlled trial in which Chinese non-dippers (n= 198) will be randomized to an exercise program plus usual care or to usual care by stratified randomization. The randomization sequence is blinded to the investigators and allocation is disclosed only after valid consent. The exercise program utilizes various motivational techniques to enhance exercise maintenance.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• systolic blood pressure(SBP) dipping status

  as defined by a lack of SBP drop of more than 10% during sleep, as detected by ambulatory blood pressure measurements (ABPM)

  at 12-week, after the EIM program

Secondary Outcomes (14)

• daytime, night-time, 24-h SBP, and DBP

  baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment

• serum lipid profile

  baseline (before the 12-week program ), at 12 weeks and 12 months after recruitment

• body mass index

  baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment

• office blood pressure

  baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment

• The Chinese version of international Physical Activity Questionnaire - short form (IPAQ-SF)

  baseline (before the 12-week program ), at 12 weeks, at 24 weeks and 12 months after recruitment

Study Arms (2)

EIM group

EXPERIMENTAL

patients with Hypertension (HT) will be recruited by a trained nurse when the patient attends the yearly to bi-yearly complication screening program called the risk assessment and management program (RAMP) program. This program is provided to all patients with HT, who are seen in the Government-funded primary care clinics in Hong Kong. The nurse will encourage the patient by motivational interviewing techniques and prescribe exercise. Combined exercise skills will be taught in the 12-week weekly exercise classes by certified physical trainers. Peer support is encouraged during and after the 12-week program. Regular feedback, prompting and problem solving will be provided by the nurse at 3m, 6m, and 12m. Exercise level will be monitored by validated wrist trackers to feedback participants, nurse and physical trainer by mobile apps and website. Resources to exercise will be made known to patients by apps, website and healthcare professionals.

Behavioral: EIM intervention group

usual care

NO INTERVENTION

There is no extra intervention to patients allocated in this arm, except that they receive information and advice on lifestyle changes including benefits from exercise from the nurse at recruitment as stated above. Participants in both arms will have no changes in medication within the first 12-week to determine the BP difference between the two groups. In Hong Kong, patients have unlimited access to emergency department and general outpatient services. All patients with HT receive RAMP program counselling and screening every 1-2 years. These are not limited by the current trial.

Interventions

EIM intervention group BEHAVIORAL

As in arm description

EIM group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SBP non-dippers
• self-reported exercise intensity and duration less than the World Health Organization recommendation, which is exercise of moderate intensity less than 150minutes/week OR exercise of vigorous intensity of less than 75 minutes/week
• Used any mobile apps on their phone (because the intervention involve use of apps to monitor and remind regular exercise)

You may not qualify if:

• Patients with diagnosed chronic obstructive lung disease and recent stroke (within last 12 months) because other evidence-proven and well-structured programmes are implemented for these patients in the hospital authority in Hong Kong
• Occupational drivers - because they need to hold their arm still during ABPM and this may be hazardous for drivers
• night-time workers
• diagnosed Obstructive Sleep Apnea
• Patients on anti-coagulants - because ABPM may induce bruises
• Patients on 3 or more medications for hypertension (on maximum tolerable doses) - these patients may have secondary HT and represent a different spectrum of organic diseases
• Patients with SBP \>180mmHg or DBP \>110mmHg - drug titration is not allowed during the 12-week program and these patients need early drug treatment
• Patient with DM - these patients will be arranged to have another EIM program especially designed for their DM.
• Patients with active spinal cord compression or spinal radiculopathy because they may not be suitable to join some exercise
• patients with atrial fibrillation are excluded because these patients have increased BP variability and may have different dipping behaviour
• patients with metallic implants or pacemakers are excluded as they are not suitable for MRI
• To maximize safety of patients, patients who are relatively contraindicated according to AHA will also be excluded
• acute myocardial infarction in last 6 months
• ongoing angina
• uncontrolled cardiac arrhythmia

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Lek Yuen Clinic

Hong Kong, Hong Kong

Location

Related Publications (1)

• Lee EK, Zhang DD, Yip BH, Cheng J, Hui SS, Yu EYT, Leung M, Chu WCW, Mihailidou AS, Wong SY. Exercise Intervention to Normalize Blood Pressure and Nocturnal Dipping in HyperTensive Patients (END-HT): Protocol of a Randomized Controlled Trial. Am J Hypertens. 2021 Aug 9;34(7):753-759. doi: 10.1093/ajh/hpab019.

  PMID: 33471104 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statistician will be masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 23, 2019
• Study Start: September 15, 2021
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

HK (1)