Overview

ACE Inhibitors Combined With Exercise for Seniors - Pilot Study

Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare, when combined with chronic exercise, the effects of perindopril, losartan, and hydrochlorothiazide.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Florida
Collaborator:
American Heart Association
Treatments:
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Diuretics
Hydrochlorothiazide
Losartan
Perindopril
Sodium Chloride Symporter Inhibitors
Criteria
Inclusion Criteria:

- Age 65 years and older

- Hypertension - untreated (Systolic Blood Pressure (SBP) ≥ 140 mm Hg or Diastolic Blood
Pressure (DBP) ≥ 90 mm Hg) or treated

- Physical limitations evidenced by either:

Score ≤ 10 on the Short Physical Performance Battery OR Walking speed < 1.2 m/sec during
400 m usual-paced test

- Sedentary lifestyle, defined as <150 min/wk of moderate physical activity as assessed
by CHAMPS questionnaire

- Willingness to participate in all study procedures

Exclusion Criteria:

- Failure to provide informed consent

- Inability to complete 400 m walk within 15 minutes without sitting or interpersonal
assistance, as an indicator of disablement and likely inability to fully engage in the
exercise intervention

- Primary indication for ACE inhibitor use, i.e. Congestive Heart Failure, CAD, diabetes

- Known hypersensitivity to ACE inhibitors

- Resistant hypertension, defined as BP > 140/90, despite the use of three or more
anti-hypertensive drugs

- Office or average home SBP > 180 mm Hg or DBP > 110 mm Hg (Average home BP in any
seven day period during trial)

- Primary renal disease

- Serum creatinine >2.5 mg/dL in men, or >2.0 mg/dL in women

- Serum potassium >5.0 molar equivalent/L

- Urinary protein > 1 on dipstick

- Abnormal liver enzymes (Aspartate transaminase (AST), Alanine transaminase (ALT), or
alkaline phosphatase > 2.5 times the upper limit of normal)

- Severe cardiac disease, including New York Heart Association Class III or IV
congestive heart failure, clinically significant aortic stenosis, history of cardiac
arrest, use of a cardiac defibrillator, or uncontrolled angina

- Acute myocardial infarction identified by ECG

- Lives in a nursing home (persons living in assisted or independent housing will not be
excluded)

- Significant cognitive impairment, defined as a known diagnosis of dementia or a
Mini-Mental State Examination exam score < 24

- Unable to communicate because of severe hearing loss or speech disorder

- Severe visual impairment, which would preclude completion of the assessments and/or
intervention

- Other significant co-morbid disease that would prevent participation in exercise

- Planning to move out of the area during the study time frame

- Simultaneous participation in another intervention trial