ACE Inhibitors Combined With Exercise for Seniors - Pilot Study

NCT01891513 | Completed DMC

• 3 other identifiers: IRB20150052513SDG17080033099-2013
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension; Aging

Keywords

Physical activity; Hypertension; Physical function; Aging

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change in body composition

  Baseline, 6 months

• Changes in circulating indices of cardiovascular risk

  Baseline, 6 months

• Change in Exercise Capacity

  Baseline, 6 months

Study Arms (3)

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.

Behavioral: Exercise; Drug: ACE inhibitor + exercise

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.

Behavioral: Exercise; Drug: Thiazide diuretic + exercise

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.

Behavioral: Exercise; Drug: Angiotensin receptor blocker + exercise

Interventions

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.

ACE inhibitor + exercise; Angiotensin receptor blocker + exercise; Thiazide diuretic + exercise

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.

Also known as: Perindopril

ACE inhibitor + exercise

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.

Also known as: Hydrochlorothiazide

Thiazide diuretic + exercise

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.

Also known as: Losartan

Angiotensin receptor blocker + exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Aging adults with hypertension and physical limitation within Alachua County

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

Sponsors & Collaborators

• University of Florida: lead
• American Heart Association: collaborator

Study Sites (1)

UF Institute on Aging Clinical and Translational Research Building

Gainesville, Florida, 32611, United States

Location

Related Links

• University of Florida Institute on Aging

MeSH Terms

Conditions

Hypertension; Motor Activity

Interventions

Exercise; Angiotensin-Converting Enzyme Inhibitors; Perindopril; Sodium Chloride Symporter Inhibitors; Hydrochlorothiazide; Angiotensin Receptor Antagonists; Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Membrane Transport Modulators; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrazoles

Study Officials

• Thomas Buford, Ph.D.

  University of Florida Department of Aging and Geriatric Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: July 3, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

US (1)