Clinical trial NCT03264443: Hypertension Approaches in the Elderly: a Lifestyle Study
Official title: Combined Training and Health Education for Hypertensive Elders: a Multicenter Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: physical activity
exercise
aging
older
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Pelotas
First posted: 2017-08-29
Enrollment: 184
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ambulatory Blood Pressure
timeFrame: Change from baseline 24-hour systolic blood pressure at 12 weeks
Secondary outcomes:
measure: Walking distance
timeFrame: Change from baseline walking distance at 12 weeks
measure: Lower limbs functional capacity
timeFrame: Change from baseline SPPB score at 12 weeks
measure: Cardiorespiratory fitness
timeFrame: Change from baseline VO2peak at 12 weeks
measure: Geriatric Depression Symptoms
timeFrame: Change from baseline GDS-15 score at 12 weeks
measure: Quality of life (QoL)
timeFrame: Change from baseline QoL score at 12 weeks
measure: Autonomic function
timeFrame: Change from baseline beat-to-beat blood pressure variability at 12 weeks
measure: Endothelial function, early adaptation
timeFrame: Change from baseline FMD at 6 weeks
measure: Endothelial function
timeFrame: Change from baseline FMD at 12 weeks
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Universidade Federal de Pelotas
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Pelotas
name: Stephanie S Pinto, PhD
role: STUDY_DIRECTOR
affiliation: Hospital de Clínicas de Porto Alegre
name: Daniel Umpierre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.