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
Protocol serial number	01EC1007A
Sponsor	Robert Bosch Hospital (Robert-Bosch-Krankenhaus) (Germany)
Funder	Federal Ministry of Education and Research (BMBF) (Germany) (ref: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

Geriatrisches Kompetenzzentrum
Robert-Bosch-Krankenhaus
Auerbachstr. 110
Stuttgart
70376
Germany

Email	klaus.pfeiffer@rbk.de

Prof Martin Hautzinger
Scientific

Abteilung für Klinische Psychologie und Entwicklungspsychologie
Universität Tübingen
Christophstr. 2
Tübingen
72072
Germany

Email	hautzinger@uni-tuebingen.de

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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
Completion date	31/08/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	102
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

19/04/2017: Publication reference added.