Hypertension Approaches in the Elderly: a Lifestyle Study (HAEL)

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Hypertension

Treatments: Behavioral: Health education; Behavioral: Combined training

Study type: Interventional

Funder types: Other

Identifiers

NCT03264443

17-0044 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 184 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 2 patient groups

Health education

Active Comparator group

Description:

Patients will receive weekly lectures on hypertension related topics during 12 weeks.

Treatment:

Behavioral: Health education

Combined training

Experimental group

Description:

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.

Treatment:

Behavioral: Combined training