Hypertension Approaches in the Elderly: a Lifestyle Study

Hypertension Clinical Trial

— HAEL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03264443
• Other study ID #: 17-0044
• Secondary ID: 17-0044
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: August 2020

Study information

• Verified date: February 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Daniel Umpierre, PhD
• Phone: +555133596332
• Email: daniel.umpierre[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Health education
Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.
• Combined 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pelotas	Pelotas	Rio Grande Do Sul
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory Blood Pressure	24h ambulatory blood pressure measured through automatic oscillometric device	Change from baseline 24-hour systolic blood pressure at 12 weeks
Secondary	Walking distance	Longest distance walked as assessed by the six-minute walk test	Change from baseline walking distance at 12 weeks
Secondary	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
Secondary	Cardiorespiratory fitness	Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing	Change from baseline VO2peak at 12 weeks
Secondary	Geriatric Depression Symptoms	15-item depression symptoms scale (GDS-15)	Change from baseline GDS-15 score at 12 weeks
Secondary	Quality of life (QoL)	World Health Organization Quality of Life questionnaire	Change from baseline QoL score at 12 weeks
Secondary	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
Secondary	Endothelial function, early adaptation	Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography	Change from baseline FMD at 6 weeks
Secondary	Endothelial function	Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography	Change from baseline FMD at 12 weeks