NCT03264443

Hypertension Approaches in the Elderly: a Lifestyle Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Health education	Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.
BEHAVIORAL	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.

Timeline

• Start date: 2017-09-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2017-08-29
• Last updated: 2020-02-12

Locations

2 sites across 1 country: Brazil