Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol 1.1
Study information
Scientific title
Maximising physical function in later life: a two-centre randomised controlled trial of progressive resistance exercise training in combination with angiotensin-converting enzyme (ACE) inhibition
Acronym
Study hypothesis
Combining angiotensin converting enzyme inhibition and resistance exercise training will confer an advantage over exercise alone for improving physical function in functionally impaired older people.
Ethics approval
East of Scotland Research Ethics Service, Ninewells Hospital & Medical School, 06/08/2009, ref: 09/S0501/48
Study design
Double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details found in the interventions field below to request a patient information sheet
Condition
Physical function
Intervention
All participants will receive 10 weeks of supervised exercise training followed by 10 weeks of unsupervised home based training. They will be randomised to receive either Perindopril 4 mg or placebo for 20 weeks along with the exercise training.
Contact details for Patient Information Sheet:
Ageing & Health
Mailbox 1
Division of Medical Sciences
Ninewells Hospital & Medical School
Dundee DD1 9SY
T: +44(0)1382 632436
Intervention type
Drug
Phase
Not Applicable
Drug names
Perindopril
Primary outcome measures
Change in six-minute walking distance. Outcomes will be measured at baseline, 10 and 20 weeks.
Secondary outcome measures
Outcomes will be measured at baseline, 10 and 20 weeks:
1. Short Physical Performance Battery (score range 0 worst function to 12 best function)
2. Hand grip strength and quadriceps strength measured using dynamometry
3. Functional Limitation Profile questionnaire
4. EuroQol questionnaire for health related quality of life
Overall trial start date
01/12/2009
Overall trial end date
31/05/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 65 years or over, either sex
2. An impairment of mobility requiring the use of a walking aid and/or dependence in functional activities of daily living requiring assistance
3. Short Physical Performance Battery (SPPB) score less than or equal to 10
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
186
Participant exclusion criteria
1. Already in receipt of ACE inhibitor or angiotensin-receptor blocker (ARB)
2. Contraindication to ACE inhibitor use (significant aortic outflow obstruction; estimated glomerular filtration rate [eGFR] less than 30 ml/hr; serum potassium greater than 5.0 mmol/l, systolic blood pressure [BP] less than 90 mmHg)
3. Clinical diagnosis of heart failure
4. Undiagnosed heart failure (left ventricular systolic dysfunction on echocardiography)
5. Regular participation in exercise training
6. Moderate to severe cognitive impairment (Mini-Mental State Examination [MMSE] less than 20/30)
7. Wheelchair bound
8. Unwilling to participate
Recruitment start date
01/12/2009
Recruitment end date
31/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
Clinical Trials Unit
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
-
A.Langston@dundee.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office of the Scottish Executive Health Department (UK) (ref: CZB/4/708)
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24201696