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| ID | Type | Description | Link |
|---|---|---|---|
| 13SDG17080033 | Other Grant/Funding Number | American Heart Association | |
| 099-2013 | Other Identifier | Univeristy of Florida |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACE inhibitor + exercise | In addition to exercise training, participants will receive an initial perindopril dose of 4 mg/day which will be titrated to 8 mg/day. |
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| Thiazide diuretic + exercise | In addition to exercise training, participants will receive an initial hydrochlorothiazide dose of 12.5 mg/day which will be titrated to 25 mg/day. |
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| Angiotensin receptor blocker + exercise | In addition to exercise training, participants will receive an initial losartan dose of 50 mg/day which will be titrated to 100 mg/day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | All participants will take part in 3 days/week of structured aerobic, stretching, and balance training for weeks 1-12. For weeks, 13-24, training will be reduced to 2 days/week and a resistance training component added. Participants will also be expected to engage in 2 bouts of 30 minutes of home-based walking per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Walking Speed | Investigators will assess walking speed by asking the participants to walk at their usual pace over a 4 m course. Participants will be instructed to stand with both feet touching the starting line and to start walking after a specific verbal command. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body composition | Changes in skeletal muscle and adipose tissue (by modulating cardiometabolic function)both fat mass and fat-free mass (FFM) will be assessed using dual energy x-ray absorptiometry (DEXA). | Baseline, 6 months |
| Changes in circulating indices of cardiovascular risk |
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Inclusion Criteria:
Score ≤ 10 on the Short Physical Performance Battery OR Walking speed < 1.2 m/sec during 400 m usual-paced test
Exclusion Criteria:
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Aging adults with hypertension and physical limitation within Alachua County
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Buford, Ph.D. | University of Florida Department of Aging and Geriatric Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Institute on Aging Clinical and Translational Research Building | Gainesville | Florida | 32611 | United States |
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| Label | URL |
|---|---|
| University of Florida Institute on Aging | View source |
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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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| ID | Term |
|---|---|
| D015444 | Exercise |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D020913 | Perindopril |
| D049993 | Sodium Chloride Symporter Inhibitors |
| D006852 | Hydrochlorothiazide |
| D057911 | Angiotensin Receptor Antagonists |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| ACE inhibitor + exercise | Drug | In addition to exercise training, participants will receive an initial perindopril dose of 2 mg/day which will be titrated to 4 mg/day. |
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| Thiazide diuretic + exercise | Drug | In addition to exercise training, participants will receive an initial hydrochlorothiazide dose of 12.5 mg/day which will be titrated to 25 mg/day. |
|
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| Angiotensin receptor blocker + exercise | Drug | In addition to exercise training, participants will receive an initial losartan dose of 50 mg/day which will be titrated to 100 mg/day. |
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Fasting blood samples (serum or plasma as appropriate) will be evaluated for blood lipids, glucose, and hemoglobin A(1c) levels. Samples will also be used to assay for prominent markers of inflammation (e.g. Tumor necrosis factor-α (TNF-α), Interleukin 6 (IL-6), Vascular cell adhesion protein 1 (VCAM-1), E-selectin) and oxidative stress, including oxidized LDL and myeloperoxidase (MPO). |
| Baseline, 6 months |
| Change in Exercise Capacity | Investigators will assess exercise capacity of participants using the six-minute (6-min) walk test, a safe and reliable test of aerobic endurance in older persons and those with cardiovascular conditions. | Baseline, 6 months |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D049990 | Membrane Transport Modulators |
| D004232 | Diuretics |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013777 | Tetrazoles |