Hypertension Approaches in the Elderly: a Lifestyle Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Combined Training and Health Education for Hypertensive Elders: a Multicenter Randomized Clinical Trial

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Health education
* Behavioral: Combined training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Health education<br>Patients will receive weekly lectures on hypertension related topics during 12 weeks. | Behavioral: Health education<br>* Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.<br>|
| Experimental: Combined training<br>Patients will complete 12 weeks of combined training (aerobic + strength exercise, 3x/week) in a pragmatic setup. In order to make the interventions more similar, contents of the health education arm will also be discussed with patients receiving this intervention. | Behavioral: Combined training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory Blood Pressure | 24h ambulatory blood pressure measured through automatic oscillometric device | Change from baseline 24-hour systolic blood pressure at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking distance | Longest distance walked as assessed by the six-minute walk test | 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 | Change from baseline SPPB score at 12 weeks | 
| Cardiorespiratory fitness | Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing | Change from baseline VO2peak at 12 weeks | 
| Geriatric Depression Symptoms | 15-item depression symptoms scale (GDS-15) | Change from baseline GDS-15 score at 12 weeks | 
| Quality of life (QoL) | World Health Organization Quality of Life questionnaire | Change from baseline QoL score at 12 weeks | 
| Autonomic function | Basal and during Stroop Color-Word Conflict Test beat-to-beat blood pressure variability | Change from baseline beat-to-beat blood pressure variability at 12 weeks | 
| Endothelial function, early adaptation | Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography | Change from baseline FMD at 6 weeks | 
| Endothelial function | Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography | Change from baseline FMD at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, exercise, aging, older