Hypertension Clinical Trial
Official title:
Multimodal Intervention to Reduce Cardiovascular Risk Among Hypertensive Older Adults
The purpose of this study is to compare, when combined with chronic exercise, the effects of perindopril, losartan, and hydrochlorothiazide.
An initial telephone screening will indicate eligibility to participate in the study. The
first study visit ("Screening visit") will further determine eligibility to participate. If
eligible to fully participate, this study will consist of a structured physical activity
program for 24 weeks. In addition, taking daily medication to control your blood pressure and
coming to the clinic for several additional assessment visits to monitor your safety and
measure study outcomes.
This physical activity program will include moderate-intensity walking, lower-body
strengthening, flexibility, and balance training. For the first 12 weeks, of participation
there will be three (3) physical activity sessions per week at the physical activity center.
These sessions will be led by investigators study staff. These sessions will be used to begin
the walking program and to introduce the participant to the strength, stretching, and balance
parts of the program in a safe manner. This will allow instructors to better tailor the
program to individual needs and abilities. These sessions will involve 40-60 minutes of
physical activity instruction. For the final 12 weeks of the intervention, there will be two
(2) of these sessions per week.
Participants will also be engage in home-based walking twice per week. This walking can be
done at home, community-based physical activity centers (YMCA, senior centers, churches,
etc.), or other appropriate facilities as desired. Participants will be asked to report the
number of minutes walked each week.
Participants will be randomly assigned to take one of three medications to continue treating
blood pressure. These medications are Perindopril, Losartan, and Hydrochlorothiazide. Each
medication represents a separate type medication commonly used in practice. These medications
are all standard, FDA-approved medications for the treatment of blood pressure. During the
time of participating in the study, the use of the normal blood pressure medication will be
replaced with the medication assigned during the study. The medications will be inserted into
identical capsules by the study pharmacy so that neither participants nor the investigators
will know which medication is being used.
Study staff will monitor blood pressure during the study under the supervision of a
board-certified cardiologist, and any necessary adjustments to the medication will be
indicated by the physician. Participants will also be provided with a blood pressure monitor
to use at home during the study and asked to check blood pressure each day and report any
abnormal values to study staff. This monitor also automatically records each blood pressure
reading. Please bring this monitor to each assessment visit so that study staff can download
the stored blood pressure readings.
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