R54 F32
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects with frailty - Category = 5/9 of the Clinical Frailty Scale fulfilled (Rockwood et al. 2005) - Criteria for a depressive disorder according to DSM-5 criteria (APA 2013) neither currently nor in the past fulfilled - Age = 65 years - male or female - right-handed Subjects with depression - Depressive disorder according to DSM-5 criteria (APA 2013), at least moderate depressive symptomatology at study inclusion, i.e., HAMD score = 17 points (Zimmerman et al. 2013) - Age = 65 years - male or female - Right-handed Subjects with frailty and depression - Category = 5/9 of the Clinical Frailty Scale met (Rockwood et al. 2005). - Depressive disorder according to DSM-5 criteria (APA 2013), at least moderate depressive symptomatology at study inclusion, i.e., HAMD score = 17 points (Zimmerman et al. 2013) - Age = 65 years - male or female - right-handed Control subjects without frailty or depression. - No frailty present according to Clinical Frailty Scale, i.e., category = 4/9 (Rockwood et al. 2005). - Criteria for a depressive disorder according to DSM-5 criteria (APA 2013) neither currently nor in the past met, HAMD score < 7 points (Zimmerman et al. 2013) - Age = 65 years - male or female - right-handed
Exclusion criteria
Exclusion criteria: - Incapacity to consent - More than mild cognitive dysfunction (MMST score = 23 points) (Folstein et al. 1975). - Criteria for a psychiatric disorder other than one defined as depression according to DSM-5 (APA 2013) currently or in the past met - Neurodegenerative disease (clinical assessment), cerebral space-occupying lesion, large cerebral infarction (territorial infarction), severe cerebral microangiopathy - history of traumatic brain injury - Acute physical illness requiring intervention (e.g., decompensated cardiac insufficiency, febrile infection, etc.) or acute suicidal tendencies. - medical condition that precludes the feasibility of the examinations (e.g. fracture, aphasia, etc.) - MRI contraindications (MR-incompatible metallic foreign bodies, MR-incompatible pacemakers, claustrophobia) - lack of SARS-CoV-2 immunization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the four groups (patients with frailty; patients with depression; patients with frailty and depression; control subjects) with respect to: - high-resolution (~1mm3) regional gray matter volume [GMV] of the whole brain; - resting state functional activity of the whole brain, using parameters of regional activity (signal variability [fALFF], signal homogeneity [ReHo]) and using parameters of neural network coupling (Independent Component Analysis (ICA)-based [connectivity within and between intrinsic neural networks]). Hypothesis 1: Patients with frailty show decreased gray matter volume of the supplementary motor area (SMA) and decreased activity and functional connectivity of the SMA compared with controls and compared with depressed patients (primary endpoint). Hypothesis 2: Patients with depression show decreased gray matter volume of the ventral striatum (VS) and decreased activity and functional connectivity of the VS compared with controls and compared with frailty (primary end point). | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the four groups (patients with frailty; patients with depression; patients with frailty and depression; control subjects) using the following motor outcome measures: - motor capacity: documented via the Short Physical Performance Battery (SPPB) [total score]; - quantitative habitual (habituated) physical activity ("motor performance"): documented via sensor-based measurement using Axivity Sensor [total activity duration], [MET/hours]; - qualitative habitual physical activity: documented via sensor-based measurement of gait pattern [variability, regularity, intensity, turning quality, smoothness]. Hypothesis 3: Patients with frailty and depression will show decreased motor capacity, decreased quantitative habitual physical activity behavior, and qualitatively worsened gait pattern compared with patients with frailty or depression and these in turn compared with controls. Hypothesis 4: Patients with frailty and depression will have reduced life-space mobility compared with patients with frailty or depression and these in turn compared with controls. Hypothesis 5: In patients with both frailty and depression, there is a neural interaction effect upon activity and functional connectivity of the SMA and a neural interaction effect upon activity and functional connectivity of the VS. Hypothesis 6: Functional connectivity of the SMA and of the VS is associated with quantitative and qualitative habitual physical activity in the entire sample. Hypothesis 7: There are commonalities among the constructs of sedentary physical activity behavior, apathy, and fatigue. Similarities will be tested via association analyses between symptom scales across the four groups and across the entire sample. Hypothesis 7: There will be commonalities in the constructs of life-space mobility and participation/social involvement across the 4 groups. Similarities will be tested via association analyses of movement analysis parameters and symptom scales across the four groups an | — |
Countries
Germany
Contacts
Sektion Kognitive NeuropsychiatrieKlinik für Allgemeine PsychiatrieZentrum für Psychosoziale MedizinUniversitätsklinikum Heidelberg