[Physical training as core component of multimodal treatment of older frail people-study protocol of a randomized controlled pilot study].

BACKGROUND AND

OBJECTIVE

Clinical practice guidelines recommend a multimodal intervention based on standardized screening for the treatment of frailty, which includes physical exercise as the main component. This study protocol describes a planned randomized controlled pilot study to evaluate the feasibility of a main study and first assessment of the effects of a multimodal, resource-oriented intervention program on frailty in older people.

METHODS AND ANALYSES: A total of 50 community-dwelling older men and women with frailty, ≥65 years of age, will be randomly allocated to the intervention or control group. The intervention group receives usual care and a multimodal intervention program. This program consists of a multidimensional screening, verbal counselling, written instructions on individual functional and health status, a home-based physical exercise program (high-intensity functional exercise program, HIFE), and support related to cognition, mood, risk of falling, medication, nutrition and self-care as required. The control group participants will receive usual care only. The feasibility will be assessed by indicators for processes, resources and management (practicability), as well as for acceptance, safety and possible effects of the intervention. The frailty index and secondary clinical endpoints will be assessed before and after the 3‑month intervention, as well as after a 3-month follow-up to estimate the effects. Data will be analyzed according to the intention-to-treat principle.

ETHICS AND DISSEMINATION: Ethical approval was obtained from the Ethics Committee of the German Physiotherapy Association (ref. number: 2017-02). Outcomes will be disseminated in a peer-reviewed journal and at specialist conferences.

TRIAL REGISTRATION NUMBER: German Clinical Trial Register: DRKS00011831.