Maximising physical function in later life: angiotensin converting enzyme inhibition and resistance exercise training

ISRCTN ISRCTN67166885
DOI https://doi.org/10.1186/ISRCTN67166885
EudraCT/CTIS number 2009-012621-12
Secondary identifying numbers Protocol 1.1
Submission date
07/08/2009
Registration date
27/08/2009
Last edited
13/04/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Marion McMurdo
Scientific

Ageing and Health
Mailbox 1
Division of Medical Sciences
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Study information

Study designDouble-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details found in the interventions field below to request a patient information sheet
Scientific titleMaximising physical function in later life: a two-centre randomised controlled trial of progressive resistance exercise training in combination with angiotensin-converting enzyme (ACE) inhibition
Study objectivesCombining 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(s)East of Scotland Research Ethics Service, Ninewells Hospital & Medical School, 06/08/2009, ref: 09/S0501/48
Health condition(s) or problem(s) studiedPhysical function
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Perindopril
Primary outcome measureSix-minute walking distance, measured at baseline, 10 and 20 weeks
Secondary outcome measuresMeasured 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 study start date01/12/2009
Completion date31/05/2012

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants186
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2009
Date of final enrolment31/05/2012

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom

Sponsor information

University of Dundee (UK)
University/education

Clinical Trials Unit
Ninewells Hospital & Medical School
Dundee
DD1 9SY
Scotland
United Kingdom

Email A.Langston@dundee.ac.uk
Website http://www.dundee.ac.uk/
ROR logo "ROR" https://ror.org/03h2bxq36

Funders

Funder type

Government

Chief Scientist Office (ref: CZB/4/708)
Government organisation / Local government
Alternative name(s)
CSO
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe protocol is available from the authors on request but is not available online.
IPD sharing planStudy 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)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2014 Yes No
Basic results 13/04/2018 13/04/2018 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN67166885_BasicResults_13Apr18.pdf
Uploaded 13/04/2018

Editorial Notes

13/04/2018: Publication and dissemination plan, IPD sharing statement, plain English summary and EudraCT number added. The basic results of this trial have been uploaded as an additional file.