If you agree, you will take part in the study for one year. We can pay for a taxi or other transport to get you to the hospital and back for each study visit if this would be helpful.
We will first phone you at home to ask you some short questions about your health, whether you have fallen, and whether you have any difficulty doing everyday activities. If these questions suggest that the study is suitable for you, we will arrange for you to visit your local hospital for a screening visit.
The Screening Visit
At the screening visit, we will go over the study information; you will have the opportunity to ask any questions you want to about the study. If you are happy to take part, we will ask you to sign a consent form.
- take a note of your medicines and medical conditions
- check your blood pressure, height and weight
- measure your muscle size using a special pair of scales that you stand on barefoot
- take a blood sample (about a teaspoonful)
- ask you to walk a few yards
- test your grip strength
- test your balance and get out of a chair ten times whilst we time you
This visit will take about 45 minutes.
The Main Study
If the screening visit confirms that you are eligible to go into the main trial, we will ask you to come up to the hospital for a slightly longer visit, which will take a couple of hours. At this visit, we will ask you to do the following:
- Walk as far as you can up and down a corridor for six minutes. You can rest as often as you want when you do this, and you can use a stick or other walking aid if you wish to.
- Test your leg strength
- Answer two questionnaires on your quality of life and daily activities
- Give some blood (about two tablespoonsful)
- Have a scan of your muscles and bones. This involves a very small dose of X-rays (less than you would get with a chest X ray) and does not involve any needles
At the end of the visit, we will ask you to fill in a questionnaire about what you eat, take home a diary to record any falls you might have over the next three months, and wear a small device (a pedometer or step counter) during the day for a week. This clips onto your waistband, and tells us how far you walk in a day. We will then give you a supply of the two study medications.
At two and five weeks, the study nurse will visit you at home to check your blood pressure, take a teaspoonful of blood, and adjust the dose of your perindopril. Each visit will take around 15 minutes.
At 3, 6, 9 and 12 months, we will ask you to attend the hospital for study visits. Each visit will take between one and two hours; we will repeat combinations of the tests that you did at the screening and baseline visits. We have shown what happens at each study visit in the diagram in the middle of this brochure.
After you finish
We will send you the study’s Newsletter which will keep you up-to-date on the study’s progress and if you have access to the internet you can log onto the study’s website; www.lacetrial.org.uk for updates. At the end of the study, we will invite you to a teaparty to tell you all about the results, and we will send a summary of the results to you as well.