HypertensionHAELNCT03264443
Hypertension Approaches in the Elderly: a Lifestyle Study
A study testing Health education and Combined training in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Health education and Combined training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Sep 2017to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 1 recruiting
- Active, not recruiting
Universidade Federal de Pelotas
Pelotas, Rio Grande do Sul
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Daniel Umpierre, PhD, +555133596332, daniel.umpierre@gmail.com
Lucas P Santos, PhD, +555133596332 ext. Santos, lucaspsantos87@gmail.com
About this study
Official title: Combined Training and Health Education for Hypertensive Elders: a Multicenter Randomized Clinical Trial
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.
Read the 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
- Being tested
- Health education, Combined training
- Keywords
- physical activity, exercise, aging, older
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health educationBehavioural
Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.
Combined trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Health education | Active comparator | Patients will receive weekly lectures on hypertension related topics during 12 weeks. Receives: Behavioral: Health education |
| Combined training | Experimental | 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. Receives: Behavioral: Combined training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Blood Pressure
24h ambulatory blood pressure measured through automatic oscillometric device
Measured: Change from baseline 24-hour systolic blood pressure at 12 weeks
Secondary outcomes (8)
Walking distance
Longest distance walked as assessed by the six-minute walk test
Measured: Change from baseline walking distance at 12 weeks
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
Measured: Change from baseline SPPB score at 12 weeks
Cardiorespiratory fitness
Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing
Measured: Change from baseline VO2peak at 12 weeks
Geriatric Depression Symptoms
15-item depression symptoms scale (GDS-15)
Measured: Change from baseline GDS-15 score at 12 weeks
Quality of life (QoL)
World Health Organization Quality of Life questionnaire
Measured: Change from baseline QoL score at 12 weeks
Autonomic function
Basal and during Stroop Color-Word Conflict Test beat-to-beat blood pressure variability
Measured: Change from baseline beat-to-beat blood pressure variability at 12 weeks
Endothelial function, early adaptation
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
Measured: Change from baseline FMD at 6 weeks
Endothelial function
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
Measured: Change from baseline FMD at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Sep 2017
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Pelotas
- Responsible party
- Sponsor
- Investigators
- Stephanie S Pinto, PhD, Study director, Federal University of PelotasDaniel Umpierre, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264443
- Sponsor's protocol ID
- 17-0044
- Other IDs
- 17-0044
- Acronym
- HAEL
- Status last verified
- Feb 2020
- First submitted
- 22 Aug 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33449605Umpierre 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.
PubMed 31142294
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Training and Health Education for Hypertensive Elders: a Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03264443
- Acronym / sponsor ID
- HAEL / 17-0044
- Conditions
- Hypertension
- Keywords
- physical activity, exercise, aging, older
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Pelotas
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health education | Active comparator | Behavioral: Health educationPatients will receive weekly lectures on hypertension related topics during 12 weeks. |
| Combined training | Experimental | Behavioral: Combined trainingPatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health educationWeekly group lectures (1h each) giving information on patient's best practices to manage hypertension. | Behavioural | Health education |
| Combined trainingCombined 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. | Behavioural | Combined training |
Primary outcome
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
8 secondary outcomes
Walking distance
Time frame: Change from baseline walking distance at 12 weeks
Lower limbs functional capacity
Time frame: Change from baseline SPPB score at 12 weeks
Cardiorespiratory fitness
Time frame: Change from baseline VO2peak at 12 weeks
Geriatric Depression Symptoms
Time frame: Change from baseline GDS-15 score at 12 weeks
Quality of life (QoL)
Time frame: Change from baseline QoL score at 12 weeks
Autonomic function
Time frame: Change from baseline beat-to-beat blood pressure variability at 12 weeks
Endothelial function, early adaptation
Time frame: Change from baseline FMD at 6 weeks
Endothelial function
Time frame: Change from baseline FMD at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 33449605Schaun 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.
- Derived from this study: PubMed 31142294Umpierre 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie S Pinto, PhD study director
Federal University of Pelotas
Daniel Umpierre, PhD principal investigator
Hospital de Clinicas de Porto Alegre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education and Combined training in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Umpierre, PhD (+555133596332, daniel.umpierre@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory Blood Pressure (time frame: Change from baseline 24-hour systolic blood pressure at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03264443, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.