Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

Not Applicable

Completed

• Conditions: Treatment-Resistant Hypertension
• Interventions: Behavioral: Structured center-based lifestyle intervention; Behavioral: Standard education and physician advice

• Registration Number: NCT03001427
• Lead Sponsor: Duke University

Brief Summary

This application proposes to extend an ongoing NHLBI clinical trial (NCT02342808) examining the efficacy of a lifestyle intervention combining the Dietary Approaches to Stop Hypertension (DASH) diet with caloric restriction and aerobic exercise to lower and control BP in individuals with RH. In the parent trial, participants with RH will be randomized to either: (1) a 4-month adjunctive lifestyle intervention designed to lower BP through exercise and diet (C-LIFE), or; (2) a standardized education and physician advice (SEPA) control condition.

The current protocol will collect additional assessments of neurocognition (executive function, processing speed, and memory), endothelial function (brachial artery flow-mediated dilation), and cerebrovascular reserve (a measure of prefrontal cortex tissue oxygenation) in 120 participants at baseline, following completion of the 4-month intervention, and again after one year, in order to examine neurocognitive improvements and their potential mediators.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Primary Completion: 2020-02-27
• Study Completion: 2020-12-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Documented resistant hypertension (RH). In the absence of a specific RH diagnosis, individuals being treated for two or more weeks with 3 antihypertensive medications of different classes, including a diuretic if tolerated, with clinic SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg, will be eligible. Individuals being treated with 4 or more antihypertensive medications, including a diuretic if tolerated, with SBP ≥ 120 or DBP ≥ 80 mm Hg will also be eligible.
• Adherent to prescribed medications
• Overweight (BMI ≥ 25 kg/m2)
• Sedentary
• Willing to be randomized to one of the 2 treatment groups and able to fully participate in intervention
• Informed consent

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Exclusion Criteria

• Secondary HTN, non-adherence to anti-HTN medications
• Severe CKD (eGFR <40 ml/min/1.73m2)
• Severe ischemic heart disease (CCS Class 3 or 4 angina or evidence of ischemia at <85% heart rate reserve on treadmill testing)
• Severe heart failure (NYHA association Class 3 or 4), high grade arrhythmias, severe valvular heart disease
• Severe asthma or chronic obstructive lung disease
• Diabetes requiring insulin
• Musculoskeletal or neurologic problems that would preclude participation in aerobic exercise training
• Major psychiatric disorder, a history of drug abuse, alcohol consumption >14 drinks/week
• Life-limiting comorbid medical condition such as cancer
• Prior gastric bypass surgery
• Currently pregnant
• Cognitively impaired

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured center-based lifestyle intervention	Structured center-based lifestyle intervention	The Structured center-based Lifestyle Intervention (C-LIFE) will include individualized plans for the DASH diet, weight management, and aerobic exercise.
Standard education and physician advice	Standard education and physician advice	The Medical Management with Standardized Education and Physician Advice (SEPA) will consist of encouragement to achieve an ideal body weight and engage in exercise as part of routine counseling in primary care, but no special program will be delivered to enhance the participants' ability to comply with these recommendations.

Primary Outcome Measures

Name	Time	Method
Executive Function composite	Baseline to immediate post-treatment (4 months)	Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index
Memory composite	Baseline to immediate post-treatment (4 months)	CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa
Processing Speed composite	Baseline to immediate post-treatment (4 months)	Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2\&7 Test

Secondary Outcome Measures

Name	Time	Method
Brachial Artery Flow-Mediated Dilation	Baseline to immediate post-treatment (4 months)
Prefrontal Cortex Tissue Oxygenation Index	Baseline to immediate post-treatment (4 months)

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States