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

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Health education
Combined training
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring physical activity, exercise, aging, older

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universidade Federal de Pelotas
  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Health education

Combined training

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Ambulatory Blood Pressure
24h ambulatory blood pressure measured through automatic oscillometric device

Secondary Outcome Measures

Walking distance
Longest distance walked as assessed by the six-minute walk test
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
Cardiorespiratory fitness
Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing
Geriatric Depression Symptoms
15-item depression symptoms scale (GDS-15)
Quality of life (QoL)
World Health Organization Quality of Life questionnaire
Autonomic function
Basal and during Stroop Color-Word Conflict Test beat-to-beat blood pressure variability
Endothelial function, early adaptation
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
Endothelial function
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography

Full Information

First Posted
August 22, 2017
Last Updated
February 11, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Pelotas
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1. Study Identification

Unique Protocol Identification Number
NCT03264443
Brief Title
Hypertension Approaches in the Elderly: a Lifestyle Study
Acronym
HAEL
Official Title
Combined Training and Health Education for Hypertensive Elders: a Multicenter Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Pelotas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
physical activity, exercise, aging, older

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health education
Arm Type
Active Comparator
Arm Description
Patients will receive weekly lectures on hypertension related topics during 12 weeks.
Arm Title
Combined training
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Health education
Intervention Description
Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.
Intervention Type
Behavioral
Intervention Name(s)
Combined training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ambulatory Blood Pressure
Description
24h ambulatory blood pressure measured through automatic oscillometric device
Time Frame
Change from baseline 24-hour systolic blood pressure at 12 weeks
Secondary Outcome Measure Information:
Title
Walking distance
Description
Longest distance walked as assessed by the six-minute walk test
Time Frame
Change from baseline walking distance at 12 weeks
Title
Lower limbs functional capacity
Description
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
Time Frame
Change from baseline SPPB score at 12 weeks
Title
Cardiorespiratory fitness
Description
Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing
Time Frame
Change from baseline VO2peak at 12 weeks
Title
Geriatric Depression Symptoms
Description
15-item depression symptoms scale (GDS-15)
Time Frame
Change from baseline GDS-15 score at 12 weeks
Title
Quality of life (QoL)
Description
World Health Organization Quality of Life questionnaire
Time Frame
Change from baseline QoL score at 12 weeks
Title
Autonomic function
Description
Basal and during Stroop Color-Word Conflict Test beat-to-beat blood pressure variability
Time Frame
Change from baseline beat-to-beat blood pressure variability at 12 weeks
Title
Endothelial function, early adaptation
Description
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
Time Frame
Change from baseline FMD at 6 weeks
Title
Endothelial function
Description
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
Time Frame
Change from baseline FMD at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Umpierre, PhD
Phone
+555133596332
Email
daniel.umpierre@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas P Santos, MSc
Phone
+555133596332
Email
lucaspsantos87@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie S Pinto, PhD
Organizational Affiliation
Federal University of Pelotas
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel Umpierre, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Pelotas
City
Pelotas
State/Province
Rio Grande Do Sul
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Umpierre, PhD
Phone
+555133596332
Email
daniel.umpierre@gmail.com
First Name & Middle Initial & Last Name & Degree
Lucas P Santos, PhD
Phone
+555133596332
Ext
Santos
Email
lucaspsantos87@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data after will be shared after trial completion. Data usage will be under the PI's auspices, but restrictions or screenings will not be imposed upon data requests. ABPM data and any deemed relevant support information (sociodemographic, clinical history and allocated groups) will be shared if available.Details regarding the study's design and statistical plan can be obtained consulting the trial's protocol. Data on other outcomes could be requested contacting the PI. Data access will be available after all participants completed the study and will remain accessible for as long as deemed necessary by the study's committee. Data sets, variables' dictionary and statistical analysis description will be made available online upon registration and acceptance of the study team's data sharing terms and policy.
IPD Sharing Time Frame
The individual participant dataset will become available at a public repository up to six months after the first study publication.
IPD Sharing Access Criteria
A simple registration will grant access to study datasets. The website for these files is not defined at the time of registration.
Citations:
PubMed Identifier
33449605
Citation
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.
Results Reference
derived
PubMed Identifier
31142294
Citation
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.
Results Reference
derived

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Hypertension Approaches in the Elderly: a Lifestyle Study

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