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| ID | Type | Description | Link |
|---|---|---|---|
| 17-0044 | Other Grant/Funding Number | FIPE/Hospital de Clínicas de Porto Alegre |
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| Name | Class |
|---|---|
| Federal University of Pelotas | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health education | Active Comparator | Patients will receive weekly lectures on hypertension related topics during 12 weeks. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health education | Behavioral | Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension. |
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| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory Blood Pressure | 24h ambulatory blood pressure measured through automatic oscillometric device | Change from baseline 24-hour systolic blood pressure at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Walking distance | Longest distance walked as assessed by the six-minute walk test | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Umpierre, PhD | Contact | +555133596332 | daniel.umpierre@gmail.com | |
| Lucas P Santos, MSc | Contact | +555133596332 | lucaspsantos87@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie S Pinto, PhD | Federal University of Pelotas | Study Director |
| Daniel Umpierre, PhD | Hospital de Clínicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Pelotas | Active, not recruiting | Pelotas | Rio Grande do Sul | Brazil | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33449605 | Derived | 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. | |
| 31142294 |
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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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The individual participant dataset will become available at a public repository up to six months after the first study publication.
A simple registration will grant access to study datasets. The website for these files is not defined at the time of registration.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| Combined training | 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. |
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| Change from baseline SPPB score at 12 weeks |
| Cardiorespiratory fitness | Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing | Change from baseline VO2peak at 12 weeks |
| Geriatric Depression Symptoms | 15-item depression symptoms scale (GDS-15) | Change from baseline GDS-15 score at 12 weeks |
| Quality of life (QoL) | World Health Organization Quality of Life questionnaire | Change from baseline QoL score at 12 weeks |
| Autonomic function | Basal and during Stroop Color-Word Conflict Test beat-to-beat blood pressure variability | 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 | Change from baseline FMD at 6 weeks |
| Endothelial function | Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography | Change from baseline FMD at 12 weeks |
| Hospital de Clínicas de Porto Alegre |
| Recruiting |
| Porto Alegre |
| Rio Grande do Sul |
| Brazil |
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| Derived |
| 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. |