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. Although perindopril improved muscle function in people who were not exercising, it is unclear if perindopril can enhance the effect of an exercise programme undertaken by older people. The aim of this study is therefore to find out if adding perindopril to exercise therapy will bring benefits over and above the improvement in muscle function seen with exercise alone in older people.
Who can participate?
People aged 65 or over who use a walking aid and/or need help with daily living activities
What does the study involve?
The study lasts for 20 weeks. Everyone in the study is invited to a twice weekly exercise class that is run in small groups. These sessions last about one and a half hours. All exercise is tailored to individual needs. Participants are provided with structured information about exercise. After 10 weeks of exercise classes, they are given an exercise diary and encouragement from a physiotherapist via telephone to keep going with exercise for another 10 weeks. At the start of the study, participants are randomly allocated to take capsules containing either perindopril or a placebo (dummy drug). Participants take one capsule a day for the 20 weeks of the study and attend visits 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 scan of the heart (echo scan), blood pressure measurement, blood sample, walking test, tests of leg strength, arm strength, balance and ability to get out of a chair, and questionnaires about quality of life and everyday function.
What are the possible benefits and risks of participating?
Participating in the exercise classes can increase muscle function and encourage participants to lead a healthy lifestyle. Those who receive the perindopril might additionally improve their muscle function and ability to exercise (if the medication works). Perindopril uncommonly can 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. Participation in the exercise classes and walking test could lead to mild tiredness.
Where is the study run from?
Ninewells Hospital & Medical School (UK)
When is the study starting and how long is it expected to run for?
December 2009 to May 2012
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
Prof. Marion McMurdo
Trial website
Additional identifiers
EudraCT number
2009-012621-12
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 measure
Six-minute walking distance, measured at baseline, 10 and 20 weeks
Secondary outcome measures
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. Health-related quality of life measured using the EuroQol questionnaire
Overall trial start date
01/12/2009
Overall trial end date
31/05/2012
Reason abandoned (if study stopped)
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 (ref: CZB/4/708)
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
The protocol is available from the authors on request but is not available online.
IPD sharing statement
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
Basic results (scientific)
See additional file ISRCTN67166885_BasicResults_13Apr18.pdf
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24201696
Publication citations
Additional files
- ISRCTN67166885_BasicResults_13Apr18.pdf Uploaded 13/04/2018