HIP Fracture REhabilitation Programme for Elderly With Hip Fractures (HIP-REP)

September 5, 2019 updated by: Carsten Bogh Juhl, Herlev and Gentofte Hospital

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

Detailed Description

Little is known about the feasibility and 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 Quality of Life (QoL). Therefore, the investigators want to evaluate whether an activity-based rehabilitation intervention across sectors is feasible 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)

18

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 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

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: 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

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)

February 1, 2019

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (ACTUAL)

February 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • HerlevGentofte

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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