Hypertension Approaches in the Elderly: a Lifestyle Study
HAEL
Combined Training and Health Education for Hypertensive Elders: a Multicenter Randomized Clinical Trial
1 other identifier
interventional
184
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Sep 2017
Typical duration for not_applicable hypertension
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2017
CompletedFirst Posted
Study publicly available on registry
August 29, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedFebruary 12, 2020
February 1, 2020
2.9 years
August 22, 2017
February 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ambulatory Blood Pressure
24h ambulatory blood pressure measured through automatic oscillometric device
Change from baseline 24-hour systolic blood pressure at 12 weeks
Secondary Outcomes (8)
Walking distance
Change from baseline walking distance at 12 weeks
Lower limbs functional capacity
Change from baseline SPPB score at 12 weeks
Cardiorespiratory fitness
Change from baseline VO2peak at 12 weeks
Geriatric Depression Symptoms
Change from baseline GDS-15 score at 12 weeks
Quality of life (QoL)
Change from baseline QoL score at 12 weeks
- +3 more secondary outcomes
Study Arms (2)
Health education
ACTIVE COMPARATORPatients will receive weekly lectures on hypertension related topics during 12 weeks.
Combined training
EXPERIMENTALPatients 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.
Interventions
Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Universidade Federal de Pelotas
Pelotas, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (2)
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.
PMID: 33449605DERIVEDUmpierre 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.
PMID: 31142294DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stephanie S Pinto, PhD
Federal University of Pelotas
- PRINCIPAL INVESTIGATOR
Daniel Umpierre, PhD
Hospital de Clínicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2017
First Posted
August 29, 2017
Study Start
September 1, 2017
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
February 12, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- 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.
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.