Hip FracturesNCT04424186
'Rehabilitation for Life'
A study testing 'Rehabilitation for Life' in people with Hip Fractures, run by Kolding Sygehus at 1 site in Denmark.
Trial summary
Despite implementing hospital quality programs after hip fracture surgery older adults often experience a decline in the level of physical function, reduced quality of life; and the mortality and readmission rates are high. 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?
- 'Rehabilitation for Life'
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Sep 2020to 9 Feb 2024
- 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
- Patients with a hip fracture
- Patients of 65 years of age or older
- Patients admitted to an orthogeriatric ward
- Patient who are citizens in one og three municipalities
Who cannot join
- Patients discharged for permanent residence in nursing homes
- Patients who cannot participate in a conversation
- Terminal registered patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Measuring Vital Signs and Coherent Rehabilitation in Primary and Secondary Sectors in Older Adults After Hip Fracture Surgery
Despite implementing hospital quality programs after hip fracture surgery older adults often experience a decline in the level of physical function, reduced quality of life; and the mortality and readmission rates are high.
Early mobilization is important in order to prevent loss of muscle mass; however to prevent morbidity an early start of strength training is also necessary. Furthermore, the risk of complications, morbidity, and mortality are associated with insufficient management of pain.
Read more
The project aims to examine the effect of measuring vital signs and consistent rehabilitation in the primary and secondary sectors in older adults after hip fracture surgery.
Method/ design:
The study is a cluster-randomized stepped wedge study. Participants will be recruited among patients admitted to an orthogeriatric ward who are 65 years of age or older and citizens in one of six municipalities. Participants are also the health professionals in the orthogeriatric ward and the six municipalities.
The six municipalities form six clusters, which are randomized, and every three-month one cluster cross from control to intervention.
The study compares usual practice (control) to an intervention named 'Rehabilitation of Life'. An intervention best described as an empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation and combined with convenient access for collaboration among professionals.
Primary outcomes: Timed Up and Go (TUG) measured 2 months after the time of operation.
The investigators hypothesize that 'Rehabilitation of Life' for older adults with a hip fracture will result in a significant reduced TUG-score in comparison to a practice not offering 'Rehabilitation of Life'.
And as the study is organised across two sectors, the Cumulated Ambulation Score (CAS) makes a second primary outcome. It is hypothesised that patients in the intervention group will achieve a significantly reduced TUG score compared to usual care.
- Conditions
- Hip Fractures
- Being tested
- 'Rehabilitation for Life', Usual care and rehabilitation
- Keywords
- Rehabilitation, cross-sectorial cooperation, older
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'Rehabilitation for Life'Other
An empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation combined with convenient access for collaboration among professionals.
Usual care and rehabilitationOther
The care and rehabilitation usual provided to patients after hip fracture surgery
| Study group | Role | What they receive |
|---|---|---|
| 'Rehabilitation for Life' | Experimental | Vital sign measurement and rehabilitation Receives: Other: 'Rehabilitation for Life' |
| Usual care and rehabilitation | Active comparator | Usual care and rehabilitation provided in primary and secondary sectors Receives: Other: Usual care and rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and go
Measures functional mobility, as the time in seconds it takes a person to rise from a chair with arms, walk 3 m and return to the chair. A higher scores mean a worse outcome
Measured: Two months after the time of operation
Cumulated Ambulation Score (CAS)
Measures basic mobility. The score 0-6. Higher scores mean a better outcome
Measured: One months after the time of operation
Secondary outcomes (2)
Timed up and go
Measures functional mobility, as the time in seconds it takes a person to rise from a chair with arms, walk 3 m and return to the chair. A higher scores mean a worse outcome
Measured: Three and six months after the time of operation
Barthel-20
A validated tool used to assess the patient's need for help to perform acitivities of daily living
Measured: 2, 3, 6 and 12 months after the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start22 Sep 2020
- Primary completion9 Apr 2023
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A cluster-randomized stepped wedge study. A design that is initiated with a period without interventions followed by a form of cross-over, in which each cluster systematic cross from control to intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kolding Sygehus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inge Bruun, post doc, Study chair, The Region of Southern Denmark and University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424186
- Sponsor's protocol ID
- SLB-Phys-06-2020
- Status last verified
- Apr 2025
- First submitted
- 5 Jun 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ipsen JA, Pedersen LT, Viberg B, Norgaard B, Suetta C, Bruun IH. Rehabilitation for life: the effect on physical function of rehabilitation and care in older adults after hip fracture-study protocol for a cluster-randomised stepped-wedge trial. Trials. 2022 May 7;23(1):375. doi: 10.1186/s13063-022-06321-w.
PubMed 35526010
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Measuring Vital Signs and Coherent Rehabilitation in Primary and Secondary Sectors in Older Adults After Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT04424186
- Acronym / sponsor ID
- SLB-Phys-06-2020
- Conditions
- Hip Fractures
- Keywords
- Rehabilitation, cross-sectorial cooperation, older
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Kolding SygehusUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 9 Apr 2023 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 9 Jun 2020 (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.
Despite implementing hospital quality programs after hip fracture surgery older adults often experience a decline in the level of physical function, reduced quality of life; and the mortality and readmission rates are high.
Early mobilization is important in order to prevent loss of muscle mass; however to prevent morbidity an early start of strength training is also necessary. Furthermore, the risk of complications, morbidity, and mortality are associated with insufficient management of pain.
The project aims to examine the effect of measuring vital signs and consistent rehabilitation in the primary and secondary sectors in older adults after hip fracture surgery.
Method/ design:
The study is a cluster-randomized stepped wedge study. Participants will be recruited among patients admitted to an orthogeriatric ward who are 65 years of age or older and citizens in one of six municipalities. Participants are also the health professionals in the orthogeriatric ward and the six municipalities.
The six municipalities form six clusters, which are randomized, and every three-month one cluster cross from control to intervention.
The study compares usual practice (control) to an intervention named 'Rehabilitation of Life'. An intervention best described as an empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation and combined with convenient access for collaboration among professionals.
Primary outcomes: Timed Up and Go (TUG) measured 2 months after the time of operation.
The investigators hypothesize that 'Rehabilitation of Life' for older adults with a hip fracture will result in a significant reduced TUG-score in comparison to a practice not offering 'Rehabilitation of Life'.
And as the study is organised across two sectors, the Cumulated Ambulation Score (CAS) makes a second primary outcome. It is hypothesised that patients in the intervention group will achieve a significantly reduced TUG score compared to usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A cluster-randomized stepped wedge study. A design that is initiated with a period without interventions followed by a form of cross-over, in which each cluster systematic cross from control to intervention.
| Arm | Type | Receives |
|---|---|---|
| 'Rehabilitation for Life' | Experimental | Other: 'Rehabilitation for Life'Vital sign measurement and rehabilitation |
| Usual care and rehabilitation | Active comparator | Other: Usual care and rehabilitationUsual care and rehabilitation provided in primary and secondary sectors |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients with a hip fracture
- Patients of 65 years of age or older
- Patients admitted to an orthogeriatric ward
- Patient who are citizens in one og three municipalities
Key exclusion criteria (3 listed)
- Patients discharged for permanent residence in nursing homes
- Patients who cannot participate in a conversation
- Terminal registered patients.
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 |
|---|---|---|
| 'Rehabilitation for Life'An empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation combined with convenient access for collaboration among professionals. | Other | 'Rehabilitation for Life' |
| Usual care and rehabilitationThe care and rehabilitation usual provided to patients after hip fracture surgery | Other | Usual care and rehabilitation |
Primary outcome
Timed up and go
Time frame: Two months after the time of operation
Measures functional mobility, as the time in seconds it takes a person to rise from a chair with arms, walk 3 m and return to the chair. A higher scores mean a worse outcome
Cumulated Ambulation Score (CAS)
Time frame: One months after the time of operation
Measures basic mobility. The score 0-6. Higher scores mean a better outcome
2 secondary outcomes
Timed up and go
Time frame: Three and six months after the time of operation
Barthel-20
Time frame: 2, 3, 6 and 12 months after the time of surgery
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 27 Apr 2025.
- Derived from this study: PubMed 35526010Ipsen JA, Pedersen LT, Viberg B, Norgaard B, Suetta C, Bruun IH. Rehabilitation for life: the effect on physical function of rehabilitation and care in older adults after hip fracture-study protocol for a cluster-randomised stepped-wedge trial. Trials. 2022 May 7;23(1):375. doi: 10.1186/s13063-022-06321-w.
- 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.
Inge Bruun, post doc study chair
The Region of Southern Denmark and University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'Rehabilitation for Life' in people with Hip Fractures, run by Kolding Sygehus 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 27 Apr 2025. 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?
Timed up and go (time frame: Two months after the time of operation). The study lists 2 primary outcomes in all. 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 NCT04424186, which also lists 1 linked publication.
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 27 Apr 2025.