An interventional study of Health education and Combined training in Hypertension, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 2 sites in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's planned enrollment of 184 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Patients will receive weekly lectures on hypertension related topics during 12 weeks.
Behavioral: Health education
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.
Behavioral: Combined training
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.
Ambulatory Blood Pressure
24h ambulatory blood pressure measured through automatic oscillometric device
Time frame: Change from baseline 24-hour systolic blood pressure at 12 weeks
Walking distance
Longest distance walked as assessed by the six-minute walk test
Time frame: 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
Time frame: Change from baseline SPPB score at 12 weeks
Cardiorespiratory fitness
Oxygen consumption at peak (VO2peak) as assessed by maximal cardiopulmonary exercise testing
Time frame: Change from baseline VO2peak at 12 weeks
Geriatric Depression Symptoms
15-item depression symptoms scale (GDS-15)
Time frame: Change from baseline GDS-15 score at 12 weeks
Quality of life (QoL)
World Health Organization Quality of Life questionnaire
Time frame: Change from baseline QoL score at 12 weeks
Autonomic function
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
Endothelial function, early adaptation
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
Time frame: Change from baseline FMD at 6 weeks
Endothelial function
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography
Time frame: Change from baseline FMD at 12 weeks
Plan to share: 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.
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.
Started Sep 2017 (actual). Primary completion is estimated for Aug 2020, 35 months after the start.
Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's planned 35 months is above that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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