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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2013
INTERVENTION: This is a randomised double‐blind controlled trial where participants will be randomly assigned to either perindopril or a matched placebo (dummy) tablet. Following screening visit to check eligibility for the trial and to collect baseline data on leg strength, balance and safety measures participants will then be randomised to receive either 2mg of perindopril or placebo for 2 weeks. They will then have blood pressure checked, adverse events monitored and bloods checked to ensure there are no safety issues. Should all be well they will have their study medications increased to 4mg for the rest of the study period, a further 13 weeks. They therefore receive study medications for 15 weeks in total in this trial. At their final study visit their leg strength, balance and blood tests will be reassessed to determine if there are any changes from baseline. During the study period they will be seen at home twice by a researcher who will check blood pressure and safety bloods. Should there be concerns with any possible side effects of the medication they will either have their study medication reduced to 2mg (if they previously tolerated that dose) or study medication will be stopped though they will be encouraged to attend for the planned 15 week end of trial visit. CONDITION: Falls in the Elderly ; Signs and Symptoms ; Tendency to fall because of old age or other unclear health problems PRIMARY OUTCOME: Anterio‐Posterior (AP) sway measured at baseline and 15 weeks SECONDARY OUTCOME: 1 Static postural stability measures: change in mediolateral sway, average sway velocity and total sway area after 15 weeks; 2. Dynamic postural stability: change in Limits of Stability (LOS) after 15 weeks; 3. Quadriceps strength: change in sometric Quadriceps Maximum Voluntary Contraction strength (QMVC) after 15 weeks; 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); 5. Magnetic femoral nerve stimulation (subset of participants who consent only):; 5.1. Change in the greatest Twitch tension generated in the Quadriceps (TwQ) using magnetic femoral nerve stimulation after 15 weeks; 5.2. Improvement in endurance and fatigue using repeated QMVC after 15 weeks 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
Epistemonikos ID: 86a393bf0cc8d25aac22c2a503544b8b95d59a92
First added on: Aug 22, 2024