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
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
-
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.