Step by Step steady on your feet - a training program to regain mobility and independence after hip or pelvic fracture
| ISRCTN | ISRCTN79191813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79191813 |
| Secondary identifying numbers | 01EC1007A |
- Submission date
- 21/04/2011
- Registration date
- 06/06/2011
- Last edited
- 19/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Klaus Pfeiffer
Scientific
Scientific
Geriatrisches Kompetenzzentrum
Robert-Bosch-Krankenhaus
Auerbachstr. 110
Stuttgart
70376
Germany
| klaus.pfeiffer@rbk.de |
Prof Martin Hautzinger
Scientific
Scientific
Abteilung für Klinische Psychologie und Entwicklungspsychologie
Universität Tübingen
Christophstr. 2
Tübingen
72072
Germany
| hautzinger@uni-tuebingen.de |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Multifactorial intervention to reduce fear of falling after a hip or pelvic fracture: a prospective, randomised controlled trial - subproject No. 5 of the consortium Prevention and Rehabilitation of Osteoporotic Fractures in Disadvantaged Populations |
| Study acronym | PROFinD 5 |
| Study objectives | Main hypothesis: Rehabilitation + fear of falling - intervention are more effective than standard inpatient rehabilitation in regard to physical activity and falls efficacy three months after discharge. Minor hypothesis: To determine the effect of the intervention on fear of falling, perceived control over falling, depression, general anxiety, quality of life and functional recovery three months after discharge. |
| Ethics approval(s) | The ethics committee of the University of Tuebingen, 04/04/2011, ref: 113/2011BO2 |
| Health condition(s) or problem(s) studied | Hip or pelvic fracture |
| Intervention | Intervention group Multifactorial intervention to increase physical activity and reduce fear of falling. It comprises of 8 additional personal contacts during the inpatient rehabilitation period, 4 telephone contacts and one home visit during two months after discharge. The intervention consists of six modules: 1. Training of a relaxation technique 2. Objectives in mobility and plan to reach them 3. Fall-related cognitions and emotions, managing critical situations 4. Individual exercise programme 5. Realising exercises and activities regulary at home 6. Fall hazards Intervention and control group: All participants receive standard inpatient rehabilitation. Interventions and assessments are delivered by different teams; the assessment team is blinded to the different groups by the study centre. Because communicating of their status by the participants a complete blinding is probably not possible. |
| Intervention type | Other |
| Primary outcome measure | 1. Physical activity 1.1. Sensor based activity monitoring 1.2. Phone-FITT physical activity questionnaire 2. Falls Efficacy 2.1. Short Falls Efficacy Scale international [Short FES-I] 2.2. Perceived ability to manage risk of falls or actual falls Measured at: T0: in the first week after admission to inpatient rehabilitation, T1: between two weeks after T0 and discharge, T2: 4 months after T0 |
| Secondary outcome measures | 1. Fall-related Criteria - Percived Control Over Falling [PCOF] 2. Mental Health Criteria 2.1. Hospital Anxiety & Depression Scale [HADS] 2.2. Revised Anxiety Control Questionnaire subscale emotion and stress [ACQ-R] 2.3. Revised Acceptance and Action Questionnaire II [AAQ-II] 3. Body Functions 3.1. Short Physical Performance Battery [SPPB] 3.2. Rivermead Mobility Index 4. Quality of life 4.1. EURO QoL-5 4.2. WHO-QoL Old, subscale social participation Measured at: T0: in the first week after admission to inpatient rehabilitation, T1: between two weeks after T0 and discharge, T2: 4 months after T0 |
| Overall study start date | 26/04/2011 |
| Completion date | 31/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 102 participants |
| Key inclusion criteria | Current inclusion criteria as of 20/02/2012: 1. Hip or pelvic fracture as main diagnosis for admission to inpatient rehabilitation 2. Age: 60 years and older 3. Concern about falling (Fear of Falling screening instrument) Previous inclusion criteria: 1. Hip or pelvic fracture within the last 8 weeks 2. Age: 60 years and older 3. Concern about falling (Fear of Falling screening instrument) |
| Key exclusion criteria | 1. Delirium 2. Shortsightedness (> 20/400) 3. Mental disease like suicidality, acute psychosis, schizophrenia, bipolar disorder, schizo-affective disorder 4. Cognitive impairment Short Orientation-Memory-Concentration (SOMC) ≥ 10 5. Living in a nursing home when the fall occured 6. Not able to understand and speak German language 7. No telephone extension or not able to communicate over the telephone 8. Moderate or severe aphasia (amnesic aphasia is no exclusion criteria), apraxia of speech 9. Capacity too low to endure the assessment 10. Diseases, that require additional time-consuming therapy during rehabilitation period (like dialysis) 11. Other medical exclusion criterias like severe inflammations or infections, mechanical instability of the osteosynthesis, terminal status 12. Place of domicile not reachable with the public transport of the region of Stuttgart |
| Date of first enrolment | 26/04/2011 |
| Date of final enrolment | 31/08/2013 |
Locations
Countries of recruitment
- Germany
Study participating centre
Robert-Bosch-Krankenhaus
Stuttgart
70376
Germany
70376
Germany
Sponsor information
Robert Bosch Hospital (Robert-Bosch-Krankenhaus) (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr. Clemens Becker
Geriatrisches Kompetenzzentrum
Auerbachstr. 110
Stuttgart
70376
Germany
| Website | http://www.rbk.de/ |
|---|---|
"ROR" |
https://ror.org/034nkkr84 |
Funders
Funder type
Government
Federal Ministry of Education and Research (BMBF) (Germany) (ref:01EC1007A)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/05/2017 | Yes | No |
Editorial Notes
19/04/2017: Publication reference added.
