Spironolactone and exercise capacity in older people

Not Applicable

Completed

Conditions: Decline in physical function with age
Not Applicable
Physical function

Registration Number: ISRCTN03869290

Lead Sponsor: niversity of Dundee (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

1. Aged 65 years and over, either sex
2. Self-reported problems with activities of daily living

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in six minute walking distance over 20 weeks from baseline

Secondary Outcome Measures

Name	Time	Method
Change in the following from baseline to 20 weeks:<br>1. Time taken to perform the timed get up and go test<br>2. EuroQol 5D (-0.59 to 1.0) and Visual Analogue Scale (0 - 100)<br>3. Functional Limitation Profile Scale<br>4. Hospital Anxiety and Depression Scale (anxiety 0 - 21; depression 0 - 21)<br>5. Incremental shuttle walk test (time and distance)