Author
GILL, THOMAS - Yale University | |
PAHOR, MARCO - University Of Florida | |
GURALNIK, JACK - University Of Maryland | |
MCDERMOTT, MARY - Northwestern University | |
KING, ABBY - Stanford University | |
BUFORD, THOMAS - University Of Florida | |
STROTMEYER, ELSA - University Of Pittsburgh | |
NELSON, MIRIAM - Tufts University | |
SINK, KAYCEE - Wake Forest School Of Medicine | |
DEMONS, JAMEHL - Wake Forest School Of Medicine | |
KASHAF, SUSAN - Yale University | |
WALKUP, MICHAEL - Wake Forest School Of Medicine | |
MILLER, MICHAEL - Wake Forest School Of Medicine | |
REID, KIERAN - Jean Mayer Human Nutrition Research Center On Aging At Tufts University | |
FIELDING, ROGER - Jean Mayer Human Nutrition Research Center On Aging At Tufts University |
Submitted to: British Medical Journal
Publication Type: Peer Reviewed Journal Publication Acceptance Date: 12/17/2015 Publication Date: 2/3/2016 Citation: Gill, T.M., Pahor, M., Guralnik, J.M., McDermott, M.M., King, A.C., Buford, T.W., Strotmeyer, E.S., Nelson, M.E., Sink, K.M., Demons, J.L., Kashaf, S.S., Walkup, M.P., Miller, M.E., Reid, K.F., Fielding, R.A. 2016. Effect of structured physical activity on prevention of serious fall injuries in adults aged 70-89: randomized clinical trial (LIFE Study). British Medical Journal. doi: 10.1136/bmj.i245. Interpretive Summary: We tested whether a long term, structured physical activity program is more effective than a health education program in reduction of risk of serious fall injuries among sedentary older people with functional limitations. The study participants included 1635 sedentary adults aged 70-89 years with functional limitations, defined as a low short physical performance battery (SPPB) score, but who were able to walk 400 meters. About half the participants were randomized to a structured, moderate intensity physical activity program conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities. The other half of the participants were randomized to a health education program consisting of workshops on topics relevant to older people and upper extremity stretching exercises. Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, were a pre-specified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to the intervention assignment. All participants were included in the analysis. In this trial, a structured physical activity program, as opposed to a health education program, did not reduce the risk of serious fall injuries among sedentary older people with functional limitations. However it is likely that there were insufficient number of individuals participating in the study to detect any difference. Instead there was suggestive evidence that the physical activity program may reduce the rate of fall related fractures and hospital admissions in men. Technical Abstract: OBJECTIVE: To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. DESIGN: Multicenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study). SETTING: Eight centers across the United States between February 2010 and December 2013. PARTICIPANTS: 1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score = 9, but who were able to walk 400 m. INTERVENTIONS: A permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises. MAIN OUTCOME MEASURES: Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis. RESULTS: Over a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men; 1.07, 0.75 to 1.53 in women; P=0.043 for interaction), fall related fractures (0.47, 0.25 to 0.86 in men; 1.12, 0.77 to 1.64 in women; P=0.017 for interaction), and fall related hospital admissions (0.41, 0.19 to 0.89 in men; 1.10, 0.65 to 1.88 in women; P=0.039 for interaction). CONCLUSIONS: In this trial, which was underpowered to detect small, but possibly important reductions in serious fall injuries, a structured physical activity program compared with a health education program did not reduce the risk of serious fall injuries among sedentary older people with functional limitations. These null results were accompanied by suggestive evidence that the physical activity program may reduce the rate of fall related fractures and hospital admissions in men. |