PreFACE Study: Preventing Falls with ACE (angiotensin-converting-enzyme) inhibitors

Not Applicable

Completed

Conditions: Falls in the Elderly
Signs and Symptoms
Tendency to fall because of old age or other unclear health problems

Registration Number: ISRCTN58995463

Lead Sponsor: niversity of Dundee/NHS Tayside (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Aged 65 years or over
2. One or more self-reported falls in previous 12 months
3. Been assessed at a Medicine for the Elderly Falls clinic in previous 2 years
4. Able to provide informed consent

Exclusion Criteria

1. Already taking ACE inhibitor (ACEi) or Angiotensin Renal Blocker (ARB)
2. Contraindication to ACE inhibitor use [previous intolerance; significant aortic outflow obstruction (peak gradient >30mmHg) serum potassium >5.0mmol/l; eGFR<30ml/hr; serum creatinine >170umol/l]
3. Patients who have stopped ACEi or ARB after specialist falls assessment in the last 6 months
4. Clinical diagnosis of heart failure or asymptomatic left ventricular systolic dysfunction
5. Systolic BP>160mmHg or <100mmHg at screening visit
6. Wheelchair bound
7. Clinical diagnosis of Parkinson?s disease
8. Current use of Nonsteroidal anti-inflammatory drugs (NSAIDs)
9. Patients who have participated in any other clinical drug trial within the previous 30 days will be excluded
10. Intolerance to lactose
11. Cognitive impairment precluding informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anterio-Posterior (AP) sway measured at baseline and 15 weeks

Secondary Outcome Measures

Name	Time	Method
1 Static postural stability measures: change in mediolateral sway, average sway velocity and total sway area after 15 weeks<br>2. Dynamic postural stability: change in Limits of Stability (LOS) after 15 weeks<br>3. Quadriceps strength: change in sometric Quadriceps Maximum Voluntary Contraction strength (QMVC) after 15 weeks<br>4 Falls rates (this study is not powered to determine this accurately but such information will provide important safety information as well as providing preliminary data for powering a future study)<br>5. Magnetic femoral nerve stimulation (subset of participants who consent only):<br>5.1. Change in the greatest Twitch tension generated in the Quadriceps (TwQ) using magnetic femoral nerve stimulation after 15 weeks<br>5.2. Improvement in endurance and fatigue using repeated QMVC after 15 weeks