Plain English Summary
Background and study aims
Recent research suggests that a medicine called perindopril that is commonly used in patients with heart problems could have a beneficial effect on muscle function. An improvement in muscle function means that less effort is needed with day to day activities and that exercise ability may improve. Perindopril has not been tested in a trial to see if giving perindopril does indeed improve physical function. The aim of this study is therefore to find out if perindopril improves walking distance and quality of life in older people with functional impairment.
Who can participate?
Older people over the age of 65 years with some dependence in activities of daily living
What does the study involve?
The study lasts for 20 weeks. At the start of the study, participants are randomly allocated to take. either perindopril or matching placebo (dummy) capsules once a day for the 20 weeks of the study. Participants are assessed at the start of the study, at 10 weeks and at 20 weeks. Each visit lasts one and a half hours. At each visit, participants undergo some or all of the following depending on which visit it is: a heart scan (echo scan), blood pressure measurement, blood sample, walking test, test of ability to get out of a chair, and questionnaires about quality of life and everyday function. Participants are also asked to wear a device on their belt (an accelerometer) during the day for a week, to measure how active they are.
What are the possible benefits and risks of participating?
Those who receive the perindopril might improve their muscle function and ability to exercise (if the medication works). Perindopril can uncommonly cause an upset stomach, dizziness or kidney problems with increases in blood levels of potassium. Participants’ blood and blood pressure are monitored to minimise the risks.
Where is the study run from?
Ninewells Hospital and Medical School (UK)
When is the study starting and how long is it expected to run for?
August 2003 to February 2006
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
Prof. Marion McMurdo
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CZB/4/88
Study information
Scientific title
A double-blind placebo-controlled trial of the effect of perindopril on muscle strength and functional capacity in older people
Acronym
Study hypothesis
Physical function and exercise capacity decline with age and are a major source of disability in older people. Recent evidence suggests a potential role for the renin-angiotensin system in modulating muscle function. We sought to examine the effect of the angiotensin converting enzyme (ACE) inhibitor perindopril on physical function in elderly people with functional impairment who had no heart failure or left ventricular systolic dysfunction.
Ethics approval
Tayside Committee on Medical Research Ethics, 2003, ref: 196/02
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Sarcopenia
Intervention
Perindopril or placebo given for a period of 20 weeks
Intervention type
Drug
Phase
Not Applicable
Drug names
Perindopril
Primary outcome measure
Change in the 6-minute walking distance over the 20 weeks
Secondary outcome measures
1. Changes in muscle function
2. Daily activity levels
3. Self-reported function
4. Health-related quality of life
Overall trial start date
06/08/2003
Overall trial end date
06/02/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Older people over the age of 65 years with some dependence in activities of daily living
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
148
Participant exclusion criteria
1. Without left ventricular systolic dysfunction
2. Already receiving an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II inhibitor
3. Contraindication to ACE inhibitors
4. Unable to give informed consent
Recruitment start date
06/08/2003
Recruitment end date
06/02/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
Chief Scientist Office of the Scottish Executive Health Department (UK)
Sponsor details
St Andrew's House
Edinburgh
EH1 3DG
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office (ref: CZB/4/88)
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
IPD sharing statement
The protocol is available from the authors on request but is not available online. Study data are available for non-commercial, bona-fide academic analyses in collaboration with the authors; decisions on data access will be made between the investigators and the Sponsor (University of Dundee). Participant consent for unrestricted sharing of individual participant data was not obtained. Contact for data sharing: Dr Catrina Forde (c.forde@dundee.ac.uk).
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN67679521_BasicResults_16May2018.pdf
Publication list
2007 results in: https://www.ncbi.nlm.nih.gov/pubmed/17923654
Publication citations
-
Results
Sumukadas D, Witham MD, Struthers AD, McMurdo ME, Effect of perindopril on physical function in elderly people with functional impairment: a randomized controlled trial., CMAJ, 2007, 177, 8, 867-874, doi: 10.1503/cmaj.061339.
Additional files
- ISRCTN67679521_BasicResults_16May2018.pdf Uploaded 16/05/2018