Condition category
Musculoskeletal Diseases
Date applied
25/01/2005
Date assigned
31/03/2005
Last edited
18/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

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

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

The study was approved by the Tayside Committee on Medical Research Ethics.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Sarcopenia

Intervention

Perindopril or placebo given for a period of 20 weeks.

Intervention type

Drug

Phase

Not Specified

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

Excluded are those without left ventricular systolic dysfunction, those already receiving an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II inhibitor, those with a contraindication to ACE inhibitors and those 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

Head of Section of Ageing & Health
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 of the Scottish Executive Health Department (UK) (ref: CZB/4/88)

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=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