Condition category
Musculoskeletal Diseases
Date applied
25/01/2005
Date assigned
31/03/2005
Last edited
21/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Marion McMurdo

ORCID ID

Contact details

Head of Section of Ageing & Health
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

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 measures

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

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

http://www.sehd.scot.nhs.uk/cso/

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

Results - basic reporting

See additional file ISRCTN67679521_BasicResults_16May2018.pdf

Publication summary

2007 results in: https://www.ncbi.nlm.nih.gov/pubmed/17923654

Publication citations

  1. 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

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.