Condition category
Not Applicable
Date applied
07/08/2009
Date assigned
27/08/2009
Last edited
19/05/2015
Prospective/Retrospective
Prospectively 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

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

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

http://www.dundee.ac.uk/

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

Publication citations

Additional files

Editorial Notes