Plain English Summary
Background and study aims
Falls are common and a major cause of concern in older people. A proven treatment to reduce the risk of falls is exercise, but many older people are unable to undertake enough exercise and if the exercise is not regular or the person stops doing it, the beneficial effects are lost. The benefit of exercise is that it improves muscle strength and stamina. This study will look at a drug, called perindopril, commonly used to treat high blood pressure that may be of benefit in improving muscle function, stability and muscle tiredness in older people at risk of falls. We will examine peoples stability, i.e. how much they tend to sway while standing, and their muscle strength before and after treatment with a 15-week course of the drug. If the drug does improve the patients stability and reduces their risk of falls it might be a useful and easy to prescribe therapy for people at risk of falls in future.
Who can participate?
Anyone aged over 65 years who has been assessed at a Medicine for the Elderly Falls clinic in the past 2 years in NHS Tayside, UK. They must have had at least one fall within the past 12 months.
What does the study involve?
Participants will be randomly allocated into two groups. One group will receive the drug and the other group will receive a dummy medication to see if there is a difference in these measurements between the two groups at the end of treatment. Participants will be asked to attend Ninewells hospital twice in a 16-20 week period. These visits will last for about two hours. Blood pressure, balance and leg strength will be measured. Participants will be asked to give a blood sample for further tests and will be given a diary to record any falls. The study nurse will also visit participants at home four times during this 16-20 week period. These home visits will take about 15 minutes. Blood pressure and some blood samples (5 ml, no more than a teaspoonful) will be checked on two further occasions when the nurse visits participants at home to ensure that the medication agrees with them. On the other two home visits the nurse will attend to give participants supplies of study drug. Some participants who consent to it will have a test to measure the strength with which their leg responds to a magnetic impulse applied to the nerve in their groin.
What are possible benefits and risks of participating?
We cannot promise the study will help individual participants but the information we get from this study will help improve the treatment of older people. Those who receive the drug may additionally improve their muscle function and balance. The drug rarely can cause an upset stomach, dizziness or kidney problems with increases in blood levels of potassium. We will monitor participants blood and blood pressure to minimise the risks. Standing on the balance platform with eyes closed or while reaching forward and sideways may make participants feel off balance. The optional test using the magnetic impulse on participants femoral nerve may feel unpleasant. They may experience a tingling feeling like when you have bumped your elbow on the funny bone. It lasts only a second or two and many older people have found it tolerable. Testing leg strength may lead to mild pain in your muscles and joints.
Where is the study run from?
The study is run from the Ageing and Health Department at Ninewells Hospital in Dundee, UK.
When is the study starting and how long is it expected to run for?
The study starts in August 2013 and recruitment is expected to run for two-and-a-half years.
Who is funding the study?
The study is funded by the Chief Scientist Office, The Scottish Government, UK.
Who is the main contact?
Dr Deepa Sumukadas
d.sumukadas@dundee.ac.uk
+44 (0)1382 383086
Trial website
Contact information
Type
Scientific
Primary contact
Dr Deepa Sumukadas
ORCID ID
Contact details
Ageing & Health
Mailbox 1
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
01382 383086
d.sumukadas@dundee.ac.uk
Additional identifiers
EudraCT number
2013-001677-24
ClinicalTrials.gov number
Protocol/serial number
2012GR06
Study information
Scientific title
Do ACE inhibitors reduce postural instability in older people? Towards a novel approach to falls prevention
Acronym
PreFACE study
Study hypothesis
Use of the ACE inhibitor, Perindopril, improves postural instability in older people. Postural instability is a phenotype of the risk of falls
Ethics approval
Approved by Scotland A Research Ethics Committee on 28th May 2013, REC Ref 13/SS/0086
Study design
Double blind randomised placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Falls in the Elderly
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Perindopril
Primary outcome measures
The primary outcome measure will be the change in Anterio-Posterior (AP) sway between perindopril and placebo groups as measured at baseline and end of 15 weeks treatment.
Secondary outcome measures
1 Static postural stability measures: change in mediolateral sway, average sway velocity and total sway area after 15 weeks of treatment
2. Dynamic postural stability: To determine if there is change in Limits of Stability (LOS) after 15 weeks of treatment with perindopril compared to placebo
3. Quadriceps strength: To determine if there is a change in sometric Quadriceps Maximum Voluntary Contraction strength (QMVC) after 15 weeks of treatment with perindopril compared to placebo
4 Falls: To determine if there is any difference in falls rates, between the perindopril and placebo groups. 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. To determine if there is a change in the greatest Twitch tension generated in the Quadriceps (TwQ) using magnetic femoral nerve stimulation after 15 weeks of treatment with perindopril compared to placebo.
5.2. To determine if there is an improvement in Endurance and fatigue using repeated QMVC after 15 weeks of treatment with perindopril compared to placebo.
Overall trial start date
01/08/2013
Overall trial end date
31/01/2016
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
80 treated
Participant 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 Parkinsons 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
Recruitment start date
01/08/2013
Recruitment end date
31/01/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ageing & Health
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee/NHS Tayside (UK)
Sponsor details
Tayside Medical Science Centre
Ninewells Hospital & Medical School
TASC Research & Development Office
Residency Block
Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 383890
tasc@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office, Scottish Government: Ref CZH/4/856
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary