Hypertension Approaches in the Elderly: a Lifestyle Study

NCT ID: NCT03264443

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-08-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Health education

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

Group Type: ACTIVE_COMPARATOR

Health education

Intervention Type: BEHAVIORAL

Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.

Combined training

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.

Group Type: EXPERIMENTAL

Combined training

Intervention Type: BEHAVIORAL

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.

Interventions

Health education

Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Pelotas

OTHER

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie S Pinto, PhD

Role: STUDY_DIRECTOR

Federal University of Pelotas

Daniel Umpierre, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Universidade Federal de Pelotas

Pelotas, Rio Grande do Sul, Brazil

Site Status: ACTIVE_NOT_RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Daniel Umpierre, PhD

Role: CONTACT

daniel.umpierre@gmail.com

+555133596332

Lucas P Santos, MSc

Role: CONTACT

lucaspsantos87@gmail.com

+555133596332

Facility Contacts

Daniel Umpierre, PhD

Role: primary

daniel.umpierre@gmail.com

+555133596332

Lucas P Santos, PhD

Role: backup

lucaspsantos87@gmail.com

+555133596332 ext. Santos

References

Schaun GZ, Alberton CL, Gomes MLB, Santos LP, Bamman MM, Mendes GF, Hafele MS, Andrade LS, Alves L, DE Ataides VA, Carmona MA, Lazaro R, Botton CE, Umpierre D, Pinto SS, Wilhelm EN. Maximal Oxygen Uptake Is Underestimated during Incremental Testing in Hypertensive Older Adults: Findings from the HAEL Study. Med Sci Sports Exerc. 2021 Jul 1;53(7):1452-1459. doi: 10.1249/MSS.0000000000002598.

Reference Type: DERIVED

PMID: 33449605 (View on PubMed)

Umpierre D, Santos LP, Botton CE, Wilhelm EN, Helal L, Schaun GZ, Ferreira GD, De Nardi AT, Pfeifer LO, da Silveira AD, Polanczyk CA, Mendes GF, Tanaka H, Alves L, Galliano L, Pescatello LS, Brizio ML, Bock PM, Campelo P, Moraes RS, Domingues MR, Schaan BD, Alberton CL, Pinto SS; The HAEL Study Group. The "Hypertension Approaches in the Elderly: a Lifestyle study" multicenter, randomized trial (HAEL Study): rationale and methodological protocol. BMC Public Health. 2019 May 29;19(1):657. doi: 10.1186/s12889-019-6970-3.

Reference Type: DERIVED

PMID: 31142294 (View on PubMed)

Other Identifiers

17-0044

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

17-0044

Identifier Type: -

Identifier Source: org_study_id