A randomized, controlled trial of quadriceps resistance exercise and vitamin D in frail older people: the Frailty Interventions Trial in Elderly Subjects (FITNESS).
OBJECTIVE
To determine the effectiveness of vitamin D and home-based quadriceps resistance exercise on reducing falls and improving the physical health of frail older people after hospital discharge.


METHODS
Multicenter, randomized, controlled trial with a factorial design.


METHODS
Five hospitals in Auckland, New Zealand, and Sydney, Australia.


METHODS
Two hundred forty-three frail older people.


METHODS
Patients were randomized to receive a single dose of vitamin D (calciferol, 300,000 IU) or placebo tablets and 10 weeks of high-intensity home-based quadriceps resistance exercise or frequency-matched visits.


METHODS
The primary endpoints were physical health according to the short-form health survey at 3 months and falls over 6 months. Physical performance and self-rated function were secondary endpoints. Assessments took place in the participants' homes at 3 and 6 months after randomization and were performed by blinded assessors.


RESULTS
There was no effect of either intervention on physical health or falls, but patients in the exercise group were at increased risk of musculoskeletal injury (risk ratio = 3.6, 95% confidence interval = 1.5-8.0). Vitamin D supplementation did not improve physical performance, even in those who were vitamin D deficient (<12 ng/mL) at baseline.


CONCLUSIONS
Neither vitamin D supplementation nor a home-based program of high-intensity quadriceps resistance exercise improved rehabilitation outcomes in frail older people after hospitalization. There was no effect of vitamin D on physical performance, and the exercises increased the risk of musculoskeletal injury. These findings do not support the routine use of these interventions at these dosages in the rehabilitation of frail older people.
Latham
Nancy K
NK
Clinical Trials Research Unit, University of Auckland, Auckland, New Zealand. nlatham@bu.edu
Anderson
Craig S
CS
Lee
Arier
A
Bennett
Derrick A
DA
Moseley
Anne
A
Cameron
Ian D
ID
D000058:Accidental Falls / Q000517:prevention & control*; D000368:Aged; D000369:Aged, 80 and over; D015444:Exercise; D005260:Female; D016330:Frail Elderly; D006801:Humans; D008297:Male; D018482:Muscle, Skeletal / Q000502:physiology; D014807:Vitamin D / Q000627:therapeutic use*
D014807:Vitamin D