Authors
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Pfeiffer, Klaus -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2015
INTERVENTION: Control group: 1. Standard inpatient rehabilitation with appropriate training 2. Additional information about motor training and activity after hip or pelvic fractures (one contact during rehabilitation) including a brochure containing a standardized exercise program after hip or pelvic fractures as a homework 3. Usual non‐controlled care including physiotherapy, if prescribed by attending physician after rehabilitation Intervention group: 1. Standard inpatient rehabilitation with appropriate training 2. Additional information about motor training and activity after hip or pelvic fractures (one contact during rehabilitation) including a brochure containing a standardized exercise program after hip or pelvic fractures as a homework 3. Information about the program 4. Usual non‐controlled care including physiotherapy, if prescribed by attending physician after rehabilitation 5. Additional multifactorial intervention to increase physical activity and improve functional performance. The intervention consists of the interventions mentioned above and the following two modules: Module 1: Training intervention [duration: 4 months; 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 and introduction of an individual training program, clarifying / discussion of security aspects during training, reduction of fall risk in daily life, information on what to do after a fall 3. Exercise program, 2 times per week for approx. 30 minutes (+ practice of a defined activity of daily living), supervised by VI (VI supervised by EI), maximum duration of a visit is 2 hours 4. Unsupervised home training, 1 ‐ 4 times per week for approx. 10‐20 minutes, depending on the capacity of the patient a CONDITION: Patients with hip or pelvic fractures and an incipient to moderate cognitive impairment ; Injury, Occupational Diseases, Poisoning PRIMARY OUTCOME: 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) 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 SECONDARY OUTCOME: 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: Carer‐related quality of life questionnaire (Carer‐Qol); 2.8. Evaluation of additional therapies, inpatient stays; 2.9. Informal nursing / care activities ; ; Measured at: T1a (at the end of the rehabilitation), T1b (at home, after rehabilitation), T2 (after the 4‐month program), T3 (follow‐up; three months after completion of the program) ; * only measured at T1a and T3; ** Not measured at T1a; ; In addition: interventional costs (economic evaluation)
Epistemonikos ID: f93e4419a9b97a91f0e67bf655613de8aa339fbe
First added on: Aug 23, 2024