Hypertension Approaches in the Elderly: a Lifestyle Study

Hospital de Clinicas de Porto Alegre184 enrolled

Overview

Two-center randomized, parallel, controlled trial which will compare a pragmatic combined training program with a health education program in 184 older adults with hypertension. This study will last 12 weeks with assessments conducted at baseline, previously to the group allocation, and after interventions. There is a set of secondary outcomes which show clinical importance to the elderly population and are possibly influenced by the tested intervention.

The present protocol describes a randomized controlled trial that aims to evaluate blood pressure effects of a pragmatic combined training program, with low equipment needs, in comparison with a health education program. The sample is composed by 184 older adults, divided in two implementation centers. Randomization ratio will be 1:1 and interventions will last 12 weeks, with three weekly sessions for the exercise arm and one to the health education arm. In order to analyze the effects of interventions in a comprehensive way, a range of variables related to ambulatory blood pressure (primary outcome), physical fitness, vascular and autonomous function, together with emotional and cognitive aspects will be evaluated in a pre-post fashion. The study's hypothesis, as well as the sample size calculation and analysis plan, is based on a superiority expectation for the exercise program in comparison with the health education program, especially for the blood pressure control, functional capacity and quality of life. The present study was designed and will be conducted by a multidisciplinary staff and follows ethical and methodological recommendations for clinical trials. It is expected that this multicenter randomized trial will provide scientific evidences with a high applicability to the non-pharmacological management of hypertension in the elderly.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

184

Conditions

Hypertension

Interventions

Health educationBEHAVIORAL

Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.

Combined trainingBEHAVIORAL

Combined training (aerobic and strength exercises), in moderate intensities (perceived exertion controlled) performed 3x/week (1h) duration with a education component (10') based on the contents of the health intervention.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hypertension diagnosis (through ambulatory blood pressure monitoring or medication use) * Verified ability to exercise * Unaltered pharmacological plan within previous 4 weeks * Willingness to participate in any of interventions Exclusion Criteria: * Inability or refusal to give written consent * Myocardial infarction, revascularization proceedings, deep vein thrombosis * Severe cardiovascular disease (class III or IV heart failure, uncontrolled arrhythmia, unstable angina, or use of implantable defibrillator * Chronic pulmonary disease which requires the use of oxygen or steroidal therapy * Incidence of cardiovascular event, hospitalization or other severe health-related event during the experimental period * High alcohol consumption (over 14 doses per week) * Renal disease needing dialysis * Language, cognitive or hearing problems * Plans of moving to another city during the study * Living together with another person enrolled in the study * Osteoarticular or muscular injuries or another health conditions which generate inability to carry on the interventions * Progressive neurological disorders (Parkinson, multiple sclerosis, etc.) * Cancer treatment in the past 2 years * A medical report indicating exercise counterindication based cardiopulmonary exercise testing

Locations (2)

Universidade Federal de Pelotas

Pelotas, Rio Grande do Sul, Brazil

ACTIVE_NOT_RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Outcomes

Primary Outcomes

Ambulatory Blood Pressure

24h ambulatory blood pressure measured through automatic oscillometric device

Time frame: Change from baseline 24-hour systolic blood pressure at 12 weeks

Secondary Outcomes

Walking distance

Longest distance walked as assessed by the six-minute walk test

Time frame: Change from baseline walking distance at 12 weeks

Lower limbs functional capacity

By using the Short Physical Performance Battery (SPPB), lower-limb mobility will be assess in the following sequence: static standing balance, walking speed and indirect muscle strength

Time frame: Change from baseline SPPB score at 12 weeks

Cardiorespiratory fitness

Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing

Time frame: Change from baseline VO2peak at 12 weeks

Geriatric Depression Symptoms

15-item depression symptoms scale (GDS-15)

Time frame: Change from baseline GDS-15 score at 12 weeks

Quality of life (QoL)

World Health Organization Quality of Life questionnaire

Time frame: Change from baseline QoL score at 12 weeks

Autonomic function

Basal and during Stroop Color-Word Conflict Test beat-to-beat blood pressure variability

Time frame: Change from baseline beat-to-beat blood pressure variability at 12 weeks

Central Contacts

Daniel Umpierre, PhD

CONTACT

+555133596332 daniel.umpierre@gmail.com

Lucas P Santos, MSc

CONTACT

+555133596332 lucaspsantos87@gmail.com

Data from ClinicalTrials.gov

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