Effects of a multimodal exercise intervention on physical and cognitive functions in patients with chronic low back pain (MultiMove): study protocol for a randomized controlled trial.

BACKGROUND: Chronic low back pain (CLBP) is a common medical condition in adults over the age of 50. It is associated with severe disability, ranging from physical impairments to psychosocial distress. Since current treatments provide only small to moderate short-term effects, alternative interventions are required, whereby guidelines recommended multimodal approaches. Dancing can be considered as an inherently multimodal approach, as it requires a combination of physical and cognitive functions. Furthermore, it has already been applied effectively in neurorehabilitation. Therefore, it seems promising to merge a dance-therapeutic component together with motor-cognitive, strength and flexibility exercises in a novel multimodal treatment (MultiMove) to target the impaired everyday mobility and cognition of CLBP patients. The aim of this study is to analyse specific physical, cognitive and psychosocial effects of MultiMove in CLBP patients.
METHODS: A prospective, two-arm, single-blinded, randomized controlled trial will be conducted with an estimated sample size of 100 CLBP patients, assigned to either the MultiMove group or a control group. The intervention group will receive MultiMove twice a week for 60 min each over a period of 12 weeks. The primary outcome will be the mobility and function of the lower extremities assessed by the Timed Up-and-Go Test. Secondary outcomes comprise further physical and physiological functions (e.g. gait variability and haemodynamic response in the prefrontal cortex during motor-cognitive dual tasks), subjective health state (e.g. disability in daily life), executive functions (e.g. cognitive flexibility) and psychosocial aspects (e.g. kinesiophobia). Measures will be taken at baseline, after the intervention and at a 12-week follow-up. It is assumed that MultiMove improves the mentioned outcome parameters. DISCUSSION: The combined assessment of changes in physical and cognitive functions as well as neuropsychological aspects in response to MultiMove will allow a better understanding of the motor-cognitive adaptations induced by multimodal exercises in CLBP patients. The specific conclusions will lead to recommendations for the conservative treatment approach in this clinically relevant patient group. TRIAL REGISTRATION: German Clinical Trial Register (ID: DRKS00021696 / 10.07.2020), https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00021696.

RCT Entities:   Population Interventions Outcomes