Patients with hip or pelvic fractures and an incipient to moderate cognitive impairment Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Control group:
1. Standard inpatient rehabilitation with appropriate training
2. Additional information about motor training and activity after hip or pelvic fractures
delivered by exercise instructor (EI) & volunteer instructor (VI)] over 4 months after rehabilitation:
1. Information about the intervention after randomization
training starts at patient’s home after the assessment T1b
2. Assessment of mobility and independency, definition of mobility and participation goals, introduction of the VI, provision
Sponsors
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), executive center: Robert Bosch Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria patients: 1. Hip or pelvic fracture if not older than 3 months 2. Community-dwelling 3. 4 m independent walking with walking aid 4. Age: 65 years and older 5. Cognitive impairment defined by having a Mini-Mental State Examination (MMSE) score of 17-26 6. Visual acuity: Snellen fraction =20/400 Inclusion criteria caregivers: 1. Supports patient = 10.5 hours per week (informal care in ADL, IADL, and supervision) 2. The support is not commercial 3 = 18 years of age 4. Willing to attend a personal consultation at the patient's home
Exclusion criteria
Exclusion criteria: Exclusion criteria patients: 1. Delirium, 2. Severe somatic or mental disease, which doesn’t allow participation, 3. Patient is not able to understand and speak German, 4. No telephone available 5. Place of domicile not reachable by public transport in the region of the study center Stuttgart or >50 km away from the study center Heidelberg, 6. Assessment T1b cannot be conducted at the person´s home in week 1-6 after rehabilitation, 7. Moderate to severe aphasia (amnestic aphasia is not an exclusion criteria) or severe apraxia of speech, 8. Progressive, terminal status, 9. Insufficient hearing ability to conduct phone calls Exclusion criteria caregivers: 1. Current mental illness or cognitive impairment that affects the ability to understand the requirements of the assessments, to participate in the intervention or to give informed consent 2. No telephone available 3. Insufficient hearing ability to conduct phone calls 4. Not able to understand and speak German
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Physical activity: Sensor based activity monitoring (activPAL™, 72 hours). Measured at: T1b (at home, after rehabilitation), T2 (after the 4-month program), T3 (follow-up; three months after completion of the program) 2. Physical Performance: Short Physical Performance Battery (SPPB; DynaPort). Measured at: T1a (at the end of rehabilitation), T1b (at home, after rehabilitation), T2 (after the 4-month program), T3 (follow-up; three months after completion of the program) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-related measures Falls self-efficacy / Fear of falling: Short Falls Efficacy Scale international (Short FES-I), Fear of Falling Questionnaire Revised (FFQ-R): 1.1. **Falls: Falls diary / weekly telephone call 1.2. Depressive symptoms: Montgomery-Asberg Depression Scale (MADRS) 1.3. Activities of daily life: *Barthel-Index, and **study specific questions 1.4. Health related quality of life: **Quality of Life in Alzheimer’s Disease (Qol-AD) Other: 1.5. Participation: Social Support Questionnaire (F-SozU: modified part B) 1.6. Pain: body chart, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 1.7. Cognition: Nuremberg Aging Inventory (NAI), subcategory: repeating numbers Economic evaluation: 1.8. Health related quality of life: EuroQol (EQ-5D) 1.9. Evaluation of additional therapies, inpatient stays, and support by care services 2. Caregiver-related measures (if existing): 2.1. ** Depressive symptoms: Centre for Epidemiological Studies – Depression Scale (CES-D) 2.2. ** Sense of competence: Sense of competence questionnaire – short version (SCQ - subscale 2: self-efficacy) 2.3. ** Negative problem orientation: Social Problem-Solving Inventory – Revised (SPSI-R, subscale negative problem orientation) 2.4. ** Subjective physical symptoms: Giessen Subjective Complaints List (GBB-24, subscale pain in the limbs) 2.5. ** Leisure time satisfaction: Leisure time satisfaction (LTS, subscale frequency) 2.6. ** External assessment of behavioral problems of the patient: Revised Memory and Behaviour Problems Checklist (RMBPC, subscale frequency) Economic evaluation: 2.7. ** Subjective health related quality of life | — |
Countries
Germany
Outcome results
None listed