Hypertension Approaches in the Elderly: a Lifestyle Study (HAEL)
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ClinicalTrials.gov Identifier: NCT03264443 |
Recruitment Status : Unknown
Verified February 2020 by Hospital de Clinicas de Porto Alegre.
Recruitment status was: Recruiting
First Posted : August 29, 2017
Last Update Posted : February 12, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Behavioral: Health education Behavioral: Combined training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 184 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Combined Training and Health Education for Hypertensive Elders: a Multicenter Randomized Clinical Trial |
Actual Study Start Date : | September 1, 2017 |
Estimated Primary Completion Date : | August 2020 |
Estimated Study Completion Date : | August 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Health education
Patients will receive weekly lectures on hypertension related topics during 12 weeks.
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Behavioral: Health education
Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension. |
Experimental: 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.
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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. |
- Ambulatory Blood Pressure [ Time Frame: Change from baseline 24-hour systolic blood pressure at 12 weeks ]24h ambulatory blood pressure measured through automatic oscillometric device
- Walking distance [ Time Frame: Change from baseline walking distance at 12 weeks ]Longest distance walked as assessed by the six-minute walk test
- Lower limbs functional capacity [ Time Frame: 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 [ Time Frame: Change from baseline VO2peak at 12 weeks ]Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing
- Geriatric Depression Symptoms [ Time Frame: Change from baseline GDS-15 score at 12 weeks ]15-item depression symptoms scale (GDS-15)
- Quality of life (QoL) [ Time Frame: Change from baseline QoL score at 12 weeks ]World Health Organization Quality of Life questionnaire
- Autonomic function [ Time Frame: 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 [ Time Frame: Change from baseline FMD at 6 weeks ]Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
- Endothelial function [ Time Frame: Change from baseline FMD at 12 weeks ]Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography

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Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03264443
Contact: Daniel Umpierre, PhD | +555133596332 | daniel.umpierre@gmail.com | |
Contact: Lucas P Santos, MSc | +555133596332 | lucaspsantos87@gmail.com |
Brazil | |
Universidade Federal de Pelotas | Active, not recruiting |
Pelotas, Rio Grande Do Sul, Brazil | |
Hospital de Clínicas de Porto Alegre | Recruiting |
Porto Alegre, Rio Grande Do Sul, Brazil | |
Contact: Daniel Umpierre, PhD +555133596332 daniel.umpierre@gmail.com | |
Contact: Lucas P Santos, PhD +555133596332 ext Santos lucaspsantos87@gmail.com |
Study Director: | Stephanie S Pinto, PhD | Federal University of Pelotas | |
Principal Investigator: | Daniel Umpierre, PhD | Hospital de Clínicas de Porto Alegre |
Responsible Party: | Hospital de Clinicas de Porto Alegre |
ClinicalTrials.gov Identifier: | NCT03264443 |
Other Study ID Numbers: |
17-0044 17-0044 ( Other Grant/Funding Number: FIPE/Hospital de Clínicas de Porto Alegre ) |
First Posted: | August 29, 2017 Key Record Dates |
Last Update Posted: | February 12, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Time Frame: | The individual participant dataset will become available at a public repository up to six months after the first study publication. |
Access Criteria: | A simple registration will grant access to study datasets. The website for these files is not defined at the time of registration. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
physical activity exercise aging older |
Hypertension Vascular Diseases Cardiovascular Diseases |