Background: Interventions that improve muscle function may slow decline in physical function and disability in later life. Recent evidence suggests that inhibition of the renin-angiotensin-aldosterone system may maintain muscle function. We evaluated the effect of aldosterone blockade on physical performance in functionally impaired older people without heart failure.
Methods: In this parallel-group, double-blind, randomized, placebo-controlled trial, community-dwelling participants aged ≥65 years with self-reported problems with activities of daily living were randomized to receive 25 mg spironolactone or identical placebo daily for 20 weeks. The primary outcome was change in 6-minute walking distance over 20 weeks. Secondary outcomes were changes in Timed Up and Go test, Incremental Shuttle Walk Test, Functional Limitation Profile, EuroQol EQ-5D, and Hospital Anxiety and Depression Scale over 20 weeks.
Results: Participants' mean (standard deviation) age was 75 (6) years. Of the 93% of participants (112/120) who completed the study, 106 remained on medication at 20 weeks. There was no significant difference in change in 6-minute walking distance at 20 weeks between the spironolactone and placebo groups (mean change, -3.2 m; 95% confidence interval, -28.9 to 22.5; P = .81). Quality of life improved significantly at 20 weeks, with an increase in EuroQol EQ-5D score of 0.10 (95% confidence interval, 0.03-0.18; P < .01) in the spironolactone group relative to the placebo group. There were no significant differences in between-group change for other secondary outcomes.
Conclusions: Spironolactone was well tolerated but did not improve physical function in older people without heart failure. Quality of life improved significantly, and the possible mechanisms for this require further study.
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