Multi-modal intervention to reduce cardiovascular risk among hypertensive older adults: Design of a randomized clinical trial

Contemp Clin Trials. 2015 Jul:43:237-42. doi: 10.1016/j.cct.2015.06.019. Epub 2015 Jun 23.

Abstract

Persons aged over 65 years account for over 75% of healthcare expenditures and deaths attributable to cardiovascular disease (CVD). Accordingly, reducing CVD risk among older adults is an important public health priority. Functional status, determined by measures of physical performance, is an important predictor of cardiovascular outcomes in older adults and declines more rapidly in seniors with hypertension. To date, physical exercise is the primary strategy for attenuating declines in functional status. Yet despite the general benefits of training, exercise alone appears to be insufficient for preventing this decline. Thus, alternative or adjuvant strategies are needed to preserve functional status among seniors with hypertension. Prior data suggest that angiotensin converting enzyme inhibitors (ACEi) may be efficacious in enhancing exercise-derived improvements in functional status yet this hypothesis has not been tested in a randomized controlled trial. The objective of this randomized, double-masked pilot trial is to gather preliminary efficacy and safety data necessary for conducting a full-scale trial to test this hypothesis. Sedentary men and women ≥ 65 years of age with functional limitations and hypertension are being recruited into this 24 week intervention study. Participants are randomly assigned to one of three conditions: (1) ACEi plus exercise training, (2) thiazide diuretic plus exercise training, or (3) AT1 receptor antagonist plus exercise training. The primary outcome is change in walking speed and secondary outcomes consist of other indices of CV risk including exercise capacity, body composition, as well as circulating indices of metabolism, inflammation and oxidative stress.

Keywords: ACE; Aging; Antihypertensive; Exercise; Hypertension; Physical activity.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angiotensin II Type 1 Receptor Blockers / therapeutic use
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / adverse effects
  • Antihypertensive Agents / therapeutic use*
  • Blood Glucose
  • Blood Pressure
  • Body Composition
  • Cardiovascular Diseases / prevention & control
  • Double-Blind Method
  • Exercise Therapy / methods*
  • Female
  • Health Status
  • Humans
  • Hypertension / therapy*
  • Lipids / blood
  • Male
  • Physical Fitness
  • Risk Factors
  • Sedentary Behavior
  • Sodium Chloride Symporter Inhibitors / therapeutic use
  • Walking

Substances

  • Angiotensin II Type 1 Receptor Blockers
  • Angiotensin-Converting Enzyme Inhibitors
  • Antihypertensive Agents
  • Blood Glucose
  • Lipids
  • Sodium Chloride Symporter Inhibitors