- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03828240
HIP Fracture REhabilitation Programme for Elderly With Hip Fractures (HIP-REP)
Objectives: To evaluate the feasibility of a HIP fracture REhabilitation Programme (HIP-REP).This study will investigate adherence, satisfaction, technical and practical circumstances regarding implementation and taking this into account when evaluating the feasibility of the HIP-REP program.
Hypothesis: By testing the feasibility of a HIP-REP for the participants and the usefulness of the selected measurement tools, the investigators will be able to evaluate and adjust the HIP-REP before evaluating this in a larger Randomized controlled trial (RCT).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Herlev
-
Copenhagen, Herlev, Denmark, 2730
- Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 65 years or older
- Recent proximal hip fracture (S 72.0 Medial femur fracture, S 72.1, Pertrochanteric femur fracture, S 72.2 Subtrochanteric femur fracture)
- Living at home prior to hip fracture in Herlev, Gentofte or Lyngby-Taarbæk municipalities
- Ability to give informed consent
- Discharged from hospital and receiving or having received rehabilitation in one municipalities within the last 3 months from onset
Exclusion Criteria:
- Not expected to be discharged to home or rehabilitation centers in the municipality
- Not able to speak and/or understand Danish
- Have prior severe physical and /or mental disabilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
OTHER: Enhanced rehabilitation
|
Eight-week activity-based intervention for elderly with hip fractures; one intervention during the hospital stay, four interventions at the elderly's municipality.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Motor and Process Skills
Time Frame: Change from baseline at motor and process skills 3 months after baseline testing
|
The assessment measures the quality of a person's activity of daily living task performance.
An observational assessment that allows for evaluation of change in motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living.
The instrument consists of 16 motor and 20 process skill abilities that are rated on a 4-point scale, In all, 36 discrete ratings of motor and process skills are made during observation.
|
Change from baseline at motor and process skills 3 months after baseline testing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
European Quality of Life Questionnaire
Time Frame: at baseline and 3 months after baseline testing
|
A survey collecting information about health related quality of life comprising five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
|
at baseline and 3 months after baseline testing
|
|
Verbal Rating Scale
Time Frame: at baseline and 3 months after baseline testing
|
An assessment measuring the intensity of pain.
The patient chooses one of those: none, mild, moderate or severe.
|
at baseline and 3 months after baseline testing
|
|
Occupational Balance Questionnaire
Time Frame: at baseline and 3 months after baseline testing
|
An assessment that measures the patients satisfaction with the amount and variation of occupations; .
It consists of 13 items measured on six-step ordinal scales.
The patient chooses one of those: Disagree, partly disagree, partly agree or agree.
|
at baseline and 3 months after baseline testing
|
|
Satisfaction with daily occupations
Time Frame: at baseline and 3 months after baseline testing
|
An instrument measuring satisfaction with everyday occupations addressing four areas of everyday occupations: work and work-related occupations, leisure occupations, domestic occupations and self-care.
The patient chooses on a scale from 1 to 7. 1 = Not satisfied to 7 = Very satisfied.
|
at baseline and 3 months after baseline testing
|
|
Cumulated Ambulation Score
Time Frame: at baseline
|
The Cumulated Ambulation Score is evaluating patients' basic mobility (getting in and out of bed, sit-to-stand from a chair and walking).
Each of the three activities is scored from 0-2, resulting in a daily score of 0-6.
|
at baseline
|
|
New Mobility Score
Time Frame: at baseline and 3 months after baseline testing
|
The New Mobility Score is a composite score of the patient's ability to perform: indoor walking, outdoor walking and shopping, providing a score between zero and three (0: not at all, 1: with help from another person, 2: with an aid, 3: no difficulty) for each function, resulting in a total score from 0 to 9, with nine indicating a high prefracture functional level.
|
at baseline and 3 months after baseline testing
|
|
Functional Recovery Score
Time Frame: at baseline and 3 months after baseline testing
|
Functional Recovery Score assess the level of function with eleven-items comprised of three main components: basic activities of daily living assessed by four items, instrumental activities of daily living assessed by six items, and mobility assessed by one item.
Basic activities of daily living comprise 44 percent of the score; instrumental activities of daily living comprise 23 percent, and mobility comprises 33 percent.
Complete independence in basic and instrumental activities of daily living and mobility results in a score of 100 percent.
|
at baseline and 3 months after baseline testing
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ropke A, Morville AL, Moller TE, Delkus ECG, Juhl CB. HIP Fracture REhabilitation Program for older adults with hip fracture (HIP-REP) based on activity of daily living: a feasibility study. BMC Geriatr. 2022 Apr 27;22(1):370. doi: 10.1186/s12877-022-03039-x.
- Ropke A, Lund K, Thrane C, Juhl C, Morville AL. Developing an individualised cross-sectoral programme based on activities of daily living to support rehabilitation of older adults with hip fracture: a qualitative study. BMJ Open. 2021 Jun 18;11(6):e044539. doi: 10.1136/bmjopen-2020-044539.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HerlevGentofte
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
-
Khoo Teck Puat HospitalMinistry of Health, SingaporeActive, not recruitingHip Fracture Surgeries | Post-operative Hip Fractures RecoverySingapore
-
Smith & Nephew, Inc.Terminated
-
Medical Centre LeeuwardenNot yet recruitingHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)Netherlands
-
San Giovanni di Dio HospitalRecruitingHip Surgery | Hip ArthroplastyItaly
-
Gaziantep City HospitalCompletedFemoral Neck Fractures | Hip SurgeryTurkey (Türkiye)
-
Carilion ClinicCompleted
-
Sheffield Teaching Hospitals NHS Foundation TrustRecruitingHip FractureUnited Kingdom
-
JointResearchRecruitingHip Fractures (ICD-10 72.01-72.2)Netherlands
-
Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
-
Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
Clinical Trials on HIP fracture REhabilitation Programme for the elderly with hip fractures
-
Medical University of ViennaCompleted
-
Aga Khan UniversityCompleted
-
The University of Hong KongRecruiting
-
Khoo Teck Puat HospitalMinistry of Health, SingaporeActive, not recruitingHip Fracture Surgeries | Post-operative Hip Fractures RecoverySingapore
-
Kasr El Aini HospitalCompleted
-
Orange Park Medical CenterNot yet recruitingAnalgesia | Hip Fractures | Nerve Block
-
POROUS GmbHEuropean CommissionActive, not recruitingHealthy | Osteoporosis | OsteopeniaAustria, Germany, Netherlands