ACE Inhibitors Combined With Exercise for Seniors - Pilot Study

Completed

Conditions studied: Hypertension, Aging

In brief

The purpose of this study is to compare, when combined with chronic exercise, the effects of perindopril, losartan, and hydrochlorothiazide.

Key facts

Study ID

NCT01891513

Run by

University of Florida

People needed

104

Starts

2014-01-01

Expected to finish

2017-06-01

Last updated by the study team

2017-07-05

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UF Institute on Aging Clinical and Translational Research Building — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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