Hypertension
Conditions
Keywords
physical activity, exercise, aging, older
Brief summary
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
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.
Interventions
BEHAVIORALHealth education
Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.
BEHAVIORALCombined training
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.
Sponsors
Federal University of Pelotas
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ambulatory Blood Pressure | Change from baseline 24-hour systolic blood pressure at 12 weeks | 24h ambulatory blood pressure measured through automatic oscillometric device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower limbs functional capacity | Change from baseline SPPB score at 12 weeks | 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 |
| Cardiorespiratory fitness | Change from baseline VO2peak at 12 weeks | Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing |
| Geriatric Depression Symptoms | Change from baseline GDS-15 score at 12 weeks | 15-item depression symptoms scale (GDS-15) |
| Walking distance | Change from baseline walking distance at 12 weeks | Longest distance walked as assessed by the six-minute walk test |
| Autonomic function | Change from baseline beat-to-beat blood pressure variability at 12 weeks | Basal and during Stroop Color-Word Conflict Test beat-to-beat blood pressure variability |
| Endothelial function, early adaptation | Change from baseline FMD at 6 weeks | Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography |
| Endothelial function | Change from baseline FMD at 12 weeks | Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography |
| Quality of life (QoL) | Change from baseline QoL score at 12 weeks | World Health Organization Quality of Life questionnaire |
Countries
Brazil
Contacts
Primary ContactDaniel Umpierre, PhD
Backup ContactLucas P Santos, MSc
Outcome results
None listed