The Role of Exercise Training in the Treatment of Resistant Hypertension

Not Applicable

Completed

• Conditions: Resistant Hypertension
• Interventions: Other: Exercise Group

• Registration Number: NCT03090529
• Lead Sponsor: Aveiro University

Brief Summary

The main purpose of this study is to assess whether exercise training reduces ambulatory blood pressure in patients with resistant hypertension. To accomplish these goals 60 patients with resistant hypertension will be recruited and randomized into exercise training or control groups and followed up for 6 months. The patients in the exercise group will participate in a 3-month outpatient program. The control group will receive usual medical care. At baseline, after the intervention and 3 months after the end of the intervention both groups will undergo several evaluations, including casual and ambulatory blood pressure, body composition, cardiorespiratory fitness, quality of life, arterial stiffness, autonomic function, and endothelial and inflammatory biomarkers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-13
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Study Start: 2017-03-30
• Primary Completion: 2019-12-30
• Study Completion: 2020-03-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

confirmed resistant hypertension, who in the previous 3 months had unchanged medication

Exclusion Criteria

1. Patients with secondary hypertension
2. Evidence of target organ damage
3. Patients with heart failure
4. Previous cardiovascular event
5. Peripheral artery disease
6. Renal failure
7. Chronic obstructive pulmonary disease
8. Systolic office blood pressure superior to 180 mmHg
9. Biomechanical limitations to physical activity
10. Those participating in regular physical activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise group	Exercise Group	The 12-week exercise-training program will include three sessions of aerobic exercise per week

Primary Outcome Measures

Name	Time	Method
Ambulatory blood pressure	Change from Baseline in Blood Pressure at 3 months	Blood pressure

Secondary Outcome Measures

Name	Time	Method
Arterial stiffness	Change from baseline to 3 months	Carotid-femoral pulse wave velocity, central pressures and aortic augmentation index and augmentation pressure.
Heart rate variability	Change from baseline to 3 months	Recordings of R-R interval data; The R-R interval will be analyzed using time domain, frequency domain and Poincare´ plot techniques.
Inflammation	Change from baseline to 3 months	Plasma levels of inflammatory and anti-inflammatory biomarkers.
Oxidative stress	Change from baseline to 3 months	Plasma levels of oxidative stress and antioxidant markers.
Circulating number of endothelial progenitor cells, circulating endothelial cells, nitric oxide and endothelial Nitric Oxide Synthase	Change from baseline to 3 months	These markers will inform endothelial function, damage and repair
Daily physical activity	Change from baseline to 3 months	Physical activity will be measured during 7 consecutive days using an accelerometer.
Casual blood pressure	Change from baseline to 3 months	Blood pressure
Dietary intake	Change from baseline to 3 months	Dietary intake will be assessed using a 4-day food diary.
VO2 max	Change from baseline to 3 months	VO2 max will be determined by the Chester step test.
Body composition	Change from baseline to 3 months	Body composition
Health-related quality of life	Change from baseline to 3 months	Health-related quality of life will be evaluated by the Short-Form 36.

Trial Locations

Locations (2)

Hypertension and Cardiovascular Unit, Hospital Pedro Hispano, ULS Matosinhos; 🇵🇹 Matosinhos, Portugal

Cardiology Department, Hospital Infante D. Pedro, Centro Hospitalar do Baixo Vouga; 🇵🇹 Aveiro, Portugal