HIP Fracture REhabilitation Programme

NCT ID: NCT04207788

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-28

Study Completion Date

2021-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hip Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Activity-based intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

HIP-REP programme offers elderly with hip fracture add on activity-focused interventions.

Group Type EXPERIMENTAL

HIP-REP

Intervention Type OTHER

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.

Usual care

The elderly with hip fracture in the control group will receive usual care.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

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.

Interventions

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HIP-REP

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Municipality of Herlev

UNKNOWN

Sponsor Role collaborator

Municipality of Gentofte

UNKNOWN

Sponsor Role collaborator

Municipality of Lyngby-Taarbaek

UNKNOWN

Sponsor Role collaborator

Municipality of Furesoe

UNKNOWN

Sponsor Role collaborator

Municipality of Rudersdal

UNKNOWN

Sponsor Role collaborator

Herlev and Gentofte Hospital

OTHER

Sponsor Role collaborator

Jonkoping University

OTHER

Sponsor Role collaborator

Intersectoral Research Unit

UNKNOWN

Sponsor Role collaborator

Metropolitan University College

OTHER

Sponsor Role collaborator

Danish Association of Occupational Therapist

OTHER

Sponsor Role collaborator

Danish Regions Development and Research

UNKNOWN

Sponsor Role collaborator

Carsten Bogh Juhl

OTHER

Sponsor Role lead

Responsible Party

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Carsten Bogh Juhl

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Copenhagen, Herlev, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 36070134 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34145009 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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H-19066989

Identifier Type: -

Identifier Source: org_study_id

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