Effectiveness of a Case Management Intervention Combined with Physical Exercise Compared to Physical Exercise Alone in Older People with High Risk of Falls: A Protocol Study of a Randomized Clinical Trial.

: There is a need for randomized clinical trials with higher quality, especially for older people at high risk of falls, with interventions that consider individual needs, comprehensiveness of care, and connection with primary health care. We designed a randomized controlled trial to examine the effects of a case management intervention combined with a physical exercise protocol on risk factors for falls, falls data, adherence, satisfaction, costs, and implementation in community-dwelling older adults with high risk of falls. : A minimum of 60 community-dwelling older people with high falls risk will participate in the randomized controlled assessor-blinded trial (MAGIC-v. 2). The trial will be conducted in a regional health department of São Paulo state (Brazil), which includes 6 cities. Participants will be randomized to the Intervention Group (case management intervention based on all individual risk factors for falls identified by a multidimensional assessment, over 16 weeks, once a week, by telephone calls). Both groups will perform a physical exercise protocol based on falls prevention for 16 weeks (twice a week) in Health Units. The assessment will be performed at baseline, after 16 weeks of intervention, after 6-month follow-up, and after 12-month follow-up. Primary outcome measures include falls data and potentially modifiable risk factors for falls. : This study has the potential to facilitate the future implementation of the intervention based on case management with a focus on fall prevention in the health sectors. : Brazilian Registry of Clinical Trials (ReBEC).