- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04207788
HIP Fracture REhabilitation Programme (HIP-REP)
March 15, 2022 updated by: Carsten Bogh Juhl
HIp Fracture REhabilitation Programme for Elderly With Hip Fracture
Objectives: To evaluate the effect of a HIP-REP on the quality and independence in ADL ability (performance), measured with the Assessment of Motor and Process Skills (AMPS) and health-related Quality of Life (QoL).
Hypothesis: The HIP-REP will increase the quality and independence in ADL performance, measured with AMPS and health-related QoL measure.
Study Overview
Detailed Description
Little is known about the effect of an intersectoral rehabilitation intervention aiming at reducing the decrease in Activities of Daily Living (ADL) ability for elderly with hip fractures.
Despite positive surgical outcomes, one-quarter dies within a year after surgery, around eight percent are readmitted to hospital, and just one-third regain their pre-fracture level of physical functioning and ADL ability.
After hip fracture, the loss of independence, and further decrease in ADL ability often persists beyond three months after surgery.
This increases the risk of social isolation, depression and thus a decrease in QoL.
Therefore, the investigators want to evaluate whether an activity-based rehabilitation intervention across sectors is effective and influences this fragile group of patients.
The investigators hope to increase the ability to safely and independently perform ADL in elderly with hip fractures, and thereby enhance their health-related QoL.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Herlev
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Copenhagen, Herlev, Denmark, 2730
- Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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, Furesoe, Rudersdal or Lyngby-Taarbæk municipalities
- Ability to give informed consent
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
HIP-REP programme offers elderly with hip fracture add on activity-focused interventions.
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HIP-REP programme is an add on to usual care which includes 5 add on individual activity-focused interventions that will be tailored to the need of elderly with hip fracture in a liaison with the health care professionals.
Home visits and follow-up phone call will be a part of programme.
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Active Comparator: Usual care
The elderly with hip fracture in the control group will receive usual care.
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The elderly in the control group will receive usual rehabilitation.
with a focus on mobilization within 24 hours postoperative as an in-patient.
In the municipality physiotherapy is offered twice a week for approximately 12 weeks postoperative focusing on neuromotor control over hip, activation and strengthening of muscles as well as increase mobility.
When relevant, the elderly receives a home visit by an occupational therapist who assess ADL behaviours, the use of assistive devices and the environmental hazards, preparing and adapting the home environment to prevent falls.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Motor and Process Skills
Time Frame: Change frombaseline at motor and process skills 3 and 6 months after baseline testing
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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.
The rating scale is based on the following criteria (Quality of performance); 4 = Competent, 3 = Questionable, 2 = Ineffective or 1 = Severely deficient.
In all, 36 discrete ratings of motor and process skills are made during observation.
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Change frombaseline at motor and process skills 3 and 6 months after baseline testing
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
European Quality of Life Questionnaire
Time Frame: At baseline and 3 and 6 months after baseline testing
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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.
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At baseline and 3 and 6 months after baseline testing
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Verbal Rating Scale
Time Frame: At baseline and 3 and 6 months after baseline testing
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An assessment measuring the intensity of pain.
The patient chooses one of those: none, mild, moderate or severe.
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At baseline and 3 and 6 months after baseline testing
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Functional Recovery Score
Time Frame: at baseline and 3 and 6 months after baseline testing
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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 100percent.
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at baseline and 3 and 6 months after baseline testing
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
- 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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 28, 2020
Primary Completion (Actual)
March 1, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
December 19, 2019
First Submitted That Met QC Criteria
December 19, 2019
First Posted (Actual)
December 23, 2019
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 15, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-19066989
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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