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Table 3 Constructs, assessment methods, parameters and data collection schedule

From: 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

Constructs Assessment methods Parameters Baseline
(t0)
Post
(t1)
Follow-up (t2)
Physical functions
 Mobility and function of the lower extremities Timed Up-and-Go Test1 Time (s) to complete the task X X X
 Functional exercise capacity and dynamic postural control Six-minute walk test with inertial measurement units (IMUs) and an electro-cardiogram Walking distance (m) in 6 min, gait kinematics (e.g. minimum toe clearance, gait variability) and heart rate X X X
 Functional leg extensor muscle power Five-repetition sit-to-stand test on a force plate Time (s) and rate of force development X X X
 Flexibility Instrumented trunk range of motion assessment Active range of motion (°) X X X
Subjective health state
 Back pain associated disability in daily life Oswestry Disability Index Total score (0–100%) X X X
 Health-related quality of life EQ-5D-5L Index value (−0.66 to 1) and subjective overall health state (0–100) X X X
Motor-cognitive dual task performance
 Static and dynamic postural control during a cognitive challenge, haemodynamic response in the prefrontal cortex (PFC) and dual task costs Single and dual task bipedal stance performance on a force plate (with and without closed eyes) as well as gait analysis with IMUs, functional near-infrared spectroscopy and finger oximeter Deviation of the center of pressure (e.g. sway and velocity), gait kinematics (e.g. minimum toe clearance, gait variability, gait velocity), oxy- and deoxyhaemoglobin concentrations in the PFC, number of correct calculations and peripheral oxygenation X X X
Executive functions
 Inhibitory control Colour-Word-Interference Test Time (s) and error rate X X X
 Cognitive flexibility Trail Making Test Time (s) and error rate X X X
Psychosocial aspects
 Fear of movement Tampa Scale of Kinesiophobia Total score (11–44) X X X
 Pain coping strategies Coping Strategies Questionnaire Total score for each coping strategy (0–36) X X X
Additional
 Sociodemographic data Intake form e.g. age, sex, education X   
 Physical characteristics Intake form e.g. height, weight X X X
 Current pain intensity Numerical rating scale Score (0–10) X X X
 Specific characteristic and treatment history of chronic pain German Pain Questionnaire Descriptive data, time period (months) of chronic pain, pain intensity (0–10) in the last 4 weeks X X X
 Level of everyday activity Freiburger Questionnaire on Physical Activity Time (h) of physical activity in a week X X X
 State fatigue Fatigue subscale of the Profile of Mood States Score (0–42) X X X
 Depression Beck Depression Inventory II Total score (0–63) X X X
  1. 1Primary outcome measure; all instruments will be presented in German