Hip FracturesHIP-REPNCT04207788
HIP Fracture REhabilitation Programme
A study testing HIP-REP in people with Hip Fractures, run by Carsten Bogh Juhl at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- HIP-REP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Jan 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital, Herlev and Gentofte
Copenhagen, Herlev, 2730
About this study
Official title: 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.
Read the 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.
- Conditions
- Hip Fractures
- Being tested
- HIP-REP, Usual care
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP-REPOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | HIP-REP programme offers elderly with hip fracture add on activity-focused interventions. Receives: Other: HIP-REP |
| Usual care | Active comparator | The elderly with hip fracture in the control group will receive usual care. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Motor and Process Skills
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.
Measured: Change frombaseline at motor and process skills 3 and 6 months after baseline testing
Secondary outcomes (3)
European Quality of Life Questionnaire
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.
Measured: At baseline and 3 and 6 months after baseline testing
Verbal Rating Scale
An assessment measuring the intensity of pain. The patient chooses one of those: none, mild, moderate or severe.
Measured: At baseline and 3 and 6 months after baseline testing
Functional Recovery Score
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.
Measured: at baseline and 3 and 6 months after baseline testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start28 Jan 2020
- Primary completion1 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Activity-based intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carsten Bogh Juhl
- Sponsor type
- University, hospital or other
- Collaborators
- Municipality of Herlev, Municipality of Gentofte, Municipality of Lyngby-Taarbaek, Municipality of Furesoe, Municipality of Rudersdal, Herlev and Gentofte Hospital, Jonkoping University, Intersectoral Research Unit, Metropolitan University College, Danish Association of Occupational Therapist, Danish Regions Development and Research
- Responsible party
- Sponsor-investigator, Carsten Bogh Juhl, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207788
- Sponsor's protocol ID
- H-19066989
- Acronym
- HIP-REP
- Status last verified
- Mar 2022
- First submitted
- 19 Dec 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36070134Ropke 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.
PubMed 34145009
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIp Fracture REhabilitation Programme for Elderly With Hip Fracture
- ClinicalTrials.gov ID
- NCT04207788
- Acronym / sponsor ID
- HIP-REP / H-19066989
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Carsten Bogh JuhlUniversity, hospital or other
- Collaborators
- Municipality of Herlev, Municipality of Gentofte, Municipality of Lyngby-Taarbaek, Municipality of Furesoe, Municipality of Rudersdal, Herlev and Gentofte Hospital, Jonkoping University, Intersectoral Research Unit, Metropolitan University College, Danish Association of Occupational Therapist, Danish Regions Development and Research
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Activity-based intervention
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: HIP-REPHIP-REP programme offers elderly with hip fracture add on activity-focused interventions. |
| Usual care | Active comparator | Other: Usual careThe elderly with hip fracture in the control group will receive usual care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIP-REPHIP-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. | Other | Intervention |
| Usual careThe 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. | Other | Usual care |
Primary outcome
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.
3 secondary outcomes
European Quality of Life Questionnaire
Time frame: 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
Functional Recovery Score
Time frame: at baseline and 3 and 6 months after baseline testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 36070134Fairhall 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.
- Derived from this study: PubMed 34145009Ropke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIP-REP in people with Hip Fractures, run by Carsten Bogh Juhl at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Motor and Process Skills (time frame: Change frombaseline at motor and process skills 3 and 6 months after baseline testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207788, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.