Spironolactone and exercise capacity in older people
ISRCTN | ISRCTN03869290 |
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DOI | https://doi.org/10.1186/ISRCTN03869290 |
EudraCT/CTIS number | 2008-002373-12 |
Secondary identifying numbers | CZB/4/635 |
- Submission date
- 07/08/2008
- Registration date
- 21/08/2008
- Last edited
- 20/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Many older people find that they become less strong as they get older, and that this loss of strength interferes with the ability to everyday activities. Loss of strength with age also leads to falls, broken bones, and the need for more help with daily activities. Although exercise works well to improve muscle strength and function even in older people, not everyone can, or wants to, exercise. Finding medications that can improve muscle function may provide an alternative way of treating this problem. Spironolactone is a medicine used to treat heart failure and high blood pressure. There is some evidence that it might have directly beneficial effects on muscle function – separate from its effects on blood pressure or the heart. This idea has not been tested before, and the aim of this study is to test whether spironolactone increases exercise capacity in functionally impaired older people without chronic heart failure.
Who can participate?
People aged 65 and over who have problems with daily living activities
What does the study involve?
Participants are randomly allocated to take either spironolactone or placebo (dummy) capsules for 5 months. Participants visit the hospital three times over the 5 months. Each visit lasts between one and two hours. At each visit, participants perform some walking tests and complete three questionnaires about how much they are able to do and how they feel. They provide details of what medicines they are taking, their blood pressure is measured and blood samples are taken (no more than a few teaspoonfuls). At the start of the study, participants undergo an echocardiography (ultrasound) scan of their heart.
What are the possible benefits and risks of participating?
Spironolactone is a diuretic drug therefore participants may pass more urine than usual. Spironolactone has been used as a medication for 60 years and is safe. However, it can occasionally cause an upset stomach, dizziness or breast enlargement. It can also increase blood potassium levels, lower sodium levels, or interfere with kidney function in some people. Blood results are closely monitored throughout the study and if any of these problems are detected, participants are taken off the medication. These problems almost always disappear on stopping the medication. The blood tests may cause some minor discomfort. Although participants are unlikely to benefit directly by taking part, those who receive the spironolactone might improve your muscle function and exercise capacity, making them feel stronger.
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?
October 2008 to April 2011
Who is funding the study?
Chief Scientist Office (UK)
Who is the main contact?
Prof. Marion McMurdo
Contact information
Scientific
Section of Ageing & Health
Division of Medicine & Therapeutics
Ninewells Hospital & Medical School
Dundee
DD1 9SY
United Kingdom
Study information
Study design | Double-blind randomised placebo-controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Effect of spironolactone on exercise capacity in older people without heart failure: a double-blind placebo-controlled trial |
Study objectives | Inhibition of the renin angiotensin aldosterone system with spironolactone will improve exercise capacity in older people without heart failure. |
Ethics approval(s) | Tayside Committee of Medical Research Ethics, 06/08/2008, ref: 08/S1402/34 |
Health condition(s) or problem(s) studied | Decline in physical function with age |
Intervention | Spironolactone 25 mg once daily or placebo once daily for a period of 20 weeks. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Spironolactone |
Primary outcome measure | Change in six minute walking distance over 20 weeks from baseline |
Secondary outcome measures | Change in the following from baseline to 20 weeks: 1. Time taken to perform the timed get up and go test 2. EuroQol 5D (-0.59 to 1.0) and Visual Analogue Scale (0 - 100) 3. Functional Limitation Profile Scale 4. Hospital Anxiety and Depression Scale (anxiety 0 - 21; depression 0 - 21) 5. Incremental shuttle walk test (time and distance) |
Overall study start date | 01/10/2008 |
Completion date | 01/04/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | 120 |
Key inclusion criteria | 1. Aged 65 years and over, either sex 2. Self-reported problems with activities of daily living |
Key exclusion criteria | 1. A clinical diagnosis of symptomatic heart failure according to the Economic and Social Research Council (ESRC) criteria 2. Asymptomatic left ventricular systolic dysfunction 3. Already taking spironolactone 4. On angiotensin converting enzyme inhibitor or angiotensin receptor blocker 5. Systolic blood pressure less than 100 mmHg 6. Serum potassium greater than 5.0 mmol/l 7. Serum sodium less than 130 mmol/l 8. Creatinine greater than 200 umol/l 9. Estimated glomerular filtration rate (eGFR) less than 30 ml 10. Addison's disease 11. Previous reported intolerance of spironolactone 12. Cognitive impairment precluding informed consent 13. Wheelchair bound 14. Unwilling to participate |
Date of first enrolment | 01/11/2008 |
Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
DD1 9SY
United Kingdom
Sponsor information
University/education
Research and Innovation Services
11 Perth Road
Dundee
DD1 4HN
Scotland
United Kingdom
Website | http://www.dundee.ac.uk/ |
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https://ror.org/03h2bxq36 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | The protocol is available from the authors on request but is not available online. |
IPD sharing plan | Study data are available on request from Dr Catrina Forde (c.forde@dundee.ac.uk) 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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/07/2013 | Yes | No | |
Basic results | 24/10/2017 | 20/11/2017 | No | No |
Additional files
- ISRCTN03869290_BasicResults_24Oct17.pdf
- Uploaded 20/11/2017
Editorial Notes
20/11/2017: The basic results of this trial have been uploaded as an additional file.
01/11/2017: Plain English summary added.
24/10/2017: Recruitment dates and IPD sharing statement added.