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

Status

Completed

Conditions

Intervention / Treatment

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

    • Herlev
      • Copenhagen, Herlev, Denmark, 2730
        • Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte

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.
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.
Active Comparator: Usual care
The elderly with hip fracture in the control group will receive usual care.
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.

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
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.
Change frombaseline at motor and process skills 3 and 6 months after baseline testing

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
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 and 6 months after baseline testing
Verbal Rating Scale
Time Frame: At baseline and 3 and 6 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 and 6 months after baseline testing
Functional Recovery Score
Time Frame: at baseline and 3 and 6 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 100percent.
at baseline and 3 and 6 months after baseline testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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