A double-blind placebo-controlled trial of the effect of perindopril on muscle strength and functional capacity in older people
| ISRCTN | ISRCTN67679521 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67679521 |
| Secondary identifying numbers | CZB/4/88 |
- Submission date
- 25/01/2005
- Registration date
- 31/03/2005
- Last edited
- 21/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Head of Section of Ageing & Health
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A double-blind placebo-controlled trial of the effect of perindopril on muscle strength and functional capacity in older people |
| Study objectives | 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(s) | Tayside Committee on Medical Research Ethics, 2003, ref: 196/02 |
| Health condition(s) or problem(s) studied | Sarcopenia |
| Intervention | Perindopril or placebo given for a period of 20 weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 06/08/2003 |
| Completion date | 06/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 148 |
| Key inclusion criteria | Older people over the age of 65 years with some dependence in activities of daily living |
| Key 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 |
| Date of first enrolment | 06/08/2003 |
| Date of final enrolment | 06/02/2006 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
DD1 9SY
United Kingdom
Sponsor information
Government
St Andrew's House
Edinburgh
EH1 3DG
United Kingdom
| Website | http://www.sehd.scot.nhs.uk/cso/ |
|---|---|
"ROR" |
https://ror.org/01bw7zm61 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/10/2007 | Yes | No | |
| Basic results | 16/05/2018 | 16/05/2018 | No | No |
Additional files
- ISRCTN67679521_BasicResults_16May2018.pdf
- Uploaded 16/05/2018
Editorial Notes
21/05/2018: Ethics approval details added.
16/05/2018: IPD sharing statement and plain English summary added. The basic results of this trial have been uploaded as an additional file.
