Femoral Neck FracturesHIPFRACNCT02780076
Recovery of Physical Functioning After Hip Fracture
A study testing Functional training program in people with Femoral Neck Fractures, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
The survivors after hip fracture often report severe pain and loss of physical functioning. The poor outcomes cause negative impact on the person's physical functioning and quality of life and put a financial burden on society. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- Functional training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteNorway
- Study dates
- 30 May 2016to 1 Jun 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
- Patients with an acute low-energy hip fracture (intracapsular, trochanteric or subtrochanteric) and treated surgically, ≥ 65 years of age, living in their own homes prior to the fracture, and able to give an informed consent.
Who cannot join
- Patients unable to walk 10 meters with or without a walking aid prior to the fracture, have a score of less than 15 points on Minimal Mental Status Evaluation (MMS-E) in the acute phase, have a pathological fracture, life expectancies of less than three months, medical contraindications for training, or are incapable of understanding and speaking the Norwegian language.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Bærum Hospital Vestre Viken, Department of medical research
Sandvika, Drammen, 3004
About this study
Official title: Recovery of Physical Functioning, Activity Level, and Quality of Life After Hip Fracture in the Fragile Elderly
The survivors after hip fracture often report severe pain and loss of physical functioning. The poor outcomes cause negative impact on the person's physical functioning and quality of life and put a financial burden on society. It is important to continue and progress the functional training that already started at the hospital, while the patients are transferred to short-term stays in a nursing home before they are returning to home. The aim presently is to examine the effects of a functional training program by a RCT design, initiated by the physiotherapist and performed by the nurses, on physical functioning while the patients are at short term stays in primary health care.
Read the detailed description
Functional training, such as walking and transfers, ought to be an important part of the rehabilitation after hip fracture. We have an assumption that it is of utmost importance to continue and progress the functional training that started in the acute phase at the hospital, also during the sub-acute phase while the patients are at short-term stays in nursing homes. However, there are indications of lack of resources in the nursing homes and that the nurses may be less concerned with their role and participation in the patients' rehabilitation process. Possibly, this creates a discontinuity in the rehabilitation efforts during short-term stays that may have a negative impact on the patients' recovery of physical functioning.
In this study the aim is to continue and progress the functional training started during hospital stay, such as training in walking and further on repetitive sit-to-stands, as part of the daily habitual routine during short-term stays in the nursing homes. This type of functional training may be motivational and easily recognizable to the patients, and it can also be carried out by the nursing staff with only initial guiding from a physiotherapist. There is lack of knowledge on the effect of additional functional training, incorporated as part of the habitual daily routine during short-term stays, on the patients' immediate and long term recovery of physical functioning and activity level after hip fracture, compared to usual care alone.
The study is designed as a single-blind randomized controlled trial (RCT), comparing the effects of additional functional training (functional training group)to usual care alone (control group) during short-term stays in nursing homes.
- Conditions
- Femoral Neck Fractures
- Being tested
- Functional training program
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional training programOther
Patients treated for hip fracture participate in a functional training program during their short-term stays at nursing homes. The program is initiated by the nurses 4 times a day for 3 weeks as part of the habitual routine.
| Study group | Role | What they receive |
|---|---|---|
| Functional training group | Experimental | Participation in a functional training program in addition to usual care. The functional training program is initiated by the nurses and consists of walking, sit-to-stands, balance training, weight transfer training, knee squats. The program is performed 4 times a day for 3 weeks while at short-term stays. Receives: Other: Functional training program |
| Control group | No intervention | Usual care only. No participation in the functional training program while at short-term stays. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the performance-based Short physical performance battery (SPPB)
Measurement of physical functioning
Measured: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Secondary outcomes (9)
Change in the performance-based measure Timed Up & Go (TUG)
Measurement of mobility
Measured: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Change in the performance-based measure Hand grip strength
Dynamometer
Measured: Change 5 days - 12 months
Descriptive performance-based measurement of physical activity, an accelerometer (activPAL)
Measurement of physical activity
Measured: Descriptive from day 5 to 19 after surgery
Pain in rest and while walking
Questionnaire
Measured: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
EuroQol (European quality of life) health status measure
Questionnaire
Measured: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
University of California Los Angeles (UCLA) activity scale
Questionnaire
Measured: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months
New Mobility Scale (NMS)
Questionnaire
Measured: Change 5 days - 12 months after surgery
Walking Habits
Questionnaire
Measured: Change 5 days - 3 months, change 5 days - 12 months after surgery
Fall efficacy scale (FES)
Questionnaire
Measured: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study start30 May 2016
- Primary completion31 Mar 2020
- Study completion1 Jun 2021 (estimated)
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 Femoral Neck 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Kristi E Heiberg, PhD, Study chair, Bærum Hospital Vestre Viken HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780076
- Sponsor's protocol ID
- 2015/2147
- Acronym
- HIPFRAC
- Status last verified
- Apr 2021
- First submitted
- 4 May 2016
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beckmann M, Bruun-Olsen V, Pripp AH, Bergland A, Smith T, Heiberg KE. Effect of an additional health-professional-led exercise programme on clinical health outcomes after hip fracture. Physiother Res Int. 2021 Apr;26(2):e1896. doi: 10.1002/pri.1896. Epub 2021 Jan 28.
PubMed 33506973Heiberg KE, Bruun-Olsen V, Bergland A. The effects of habitual functional training on physical functioning in patients after hip fracture: the protocol of the HIPFRAC study. BMC Geriatr. 2017 Jan 17;17(1):23. doi: 10.1186/s12877-016-0398-8.
PubMed 28095787
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Physical Functioning, Activity Level, and Quality of Life After Hip Fracture in the Fragile Elderly
- ClinicalTrials.gov ID
- NCT02780076
- Acronym / sponsor ID
- HIPFRAC / 2015/2147
- Conditions
- Femoral Neck Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo Metropolitan University
- Study start
- 30 May 2016 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 23 May 2016 (estimated)
- 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.
The survivors after hip fracture often report severe pain and loss of physical functioning. The poor outcomes cause negative impact on the person's physical functioning and quality of life and put a financial burden on society. It is important to continue and progress the functional training that already started at the hospital, while the patients are transferred to short-term stays in a nursing home before they are returning to home. The aim presently is to examine the effects of a functional training program by a RCT design, initiated by the physiotherapist and performed by the nurses, on physical functioning while the patients are at short term stays in primary health care.
Detailed description
Functional training, such as walking and transfers, ought to be an important part of the rehabilitation after hip fracture. We have an assumption that it is of utmost importance to continue and progress the functional training that started in the acute phase at the hospital, also during the sub-acute phase while the patients are at short-term stays in nursing homes. However, there are indications of lack of resources in the nursing homes and that the nurses may be less concerned with their role and participation in the patients' rehabilitation process. Possibly, this creates a discontinuity in the rehabilitation efforts during short-term stays that may have a negative impact on the patients' recovery of physical functioning.
In this study the aim is to continue and progress the functional training started during hospital stay, such as training in walking and further on repetitive sit-to-stands, as part of the daily habitual routine during short-term stays in the nursing homes. This type of functional training may be motivational and easily recognizable to the patients, and it can also be carried out by the nursing staff with only initial guiding from a physiotherapist. There is lack of knowledge on the effect of additional functional training, incorporated as part of the habitual daily routine during short-term stays, on the patients' immediate and long term recovery of physical functioning and activity level after hip fracture, compared to usual care alone.
The study is designed as a single-blind randomized controlled trial (RCT), comparing the effects of additional functional training (functional training group)to usual care alone (control group) during short-term stays in nursing homes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional training group | Experimental | Other: Functional training programParticipation in a functional training program in addition to usual care. The functional training program is initiated by the nurses and consists of walking, sit-to-stands, balance training, weight transfer training, knee squats. The program is performed 4 times a day for 3 weeks while at short-term stays. |
| Control group | No intervention | –Usual care only. No participation in the functional training program while at short-term stays. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients with an acute low-energy hip fracture (intracapsular, trochanteric or subtrochanteric) and treated surgically, ≥ 65 years of age, living in their own homes prior to the fracture, and able to give an informed consent.
Key exclusion criteria (1 listed)
- Patients unable to walk 10 meters with or without a walking aid prior to the fracture, have a score of less than 15 points on Minimal Mental Status Evaluation (MMS-E) in the acute phase, have a pathological fracture, life expectancies of less than three months, medical contraindications for training, or are incapable of understanding and speaking the Norwegian language.
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 |
|---|---|---|
| Functional training programPatients treated for hip fracture participate in a functional training program during their short-term stays at nursing homes. The program is initiated by the nurses 4 times a day for 3 weeks as part of the habitual routine. | Other | Functional training group |
Primary outcome
Change in the performance-based Short physical performance battery (SPPB)
Time frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Measurement of physical functioning
9 secondary outcomes
Change in the performance-based measure Timed Up & Go (TUG)
Time frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Change in the performance-based measure Hand grip strength
Time frame: Change 5 days - 12 months
Descriptive performance-based measurement of physical activity, an accelerometer (activPAL)
Time frame: Descriptive from day 5 to 19 after surgery
Pain in rest and while walking
Time frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
EuroQol (European quality of life) health status measure
Time frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
University of California Los Angeles (UCLA) activity scale
Time frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months
New Mobility Scale (NMS)
Time frame: Change 5 days - 12 months after surgery
Walking Habits
Time frame: Change 5 days - 3 months, change 5 days - 12 months after surgery
Fall efficacy scale (FES)
Time frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 33506973Beckmann M, Bruun-Olsen V, Pripp AH, Bergland A, Smith T, Heiberg KE. Effect of an additional health-professional-led exercise programme on clinical health outcomes after hip fracture. Physiother Res Int. 2021 Apr;26(2):e1896. doi: 10.1002/pri.1896. Epub 2021 Jan 28.
- Derived from this study: PubMed 28095787Heiberg KE, Bruun-Olsen V, Bergland A. The effects of habitual functional training on physical functioning in patients after hip fracture: the protocol of the HIPFRAC study. BMC Geriatr. 2017 Jan 17;17(1):23. doi: 10.1186/s12877-016-0398-8.
- 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.
Kristi E Heiberg, PhD study chair
Bærum Hospital Vestre Viken HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional training program in people with Femoral Neck Fractures, run by Vestre Viken Hospital Trust at 1 site in Norway.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Apr 2021. 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 Norway. 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?
Results are not available in the source record.
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?
Change in the performance-based Short physical performance battery (SPPB) (time frame: Change 5 days - 3 weeks, change 5 days - 3 months, change 5 days - 12 months after surgery). 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 NCT02780076, 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 19 Apr 2021.