Hip FractureNCT02815254
Better Hips- Better Function
A study testing High intensity functional exercise and Low intensity functional exercise in people with Hip Fracture, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
The focus of this project are elderly people who have experienced hip fracture and need at least two weeks rehabilitation after discharge from hospital. The aim is to increase the evidence-based knowledge base for planning and appropriate follow-up intervention for patients with hip fracture on short-term /… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- High intensity functional exercise and Low intensity functional exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2015to Oct 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
- Fractura colli femoris, pertrochantar or subtrochantar)
- Discharged from hospital within 3 weeks since surgery.
- Need of minimum two weeks rehabilitation
- Life expectancy of more than one month
- Able to walk at least 3 m with walking aid
- Willingness to participate
- Able to follow instructions
- 65 years or older
Who cannot join
- -Other reasons for gait impairment than hip fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise in Elderly Hip Fracture Patients: a Clinical Randomised Trial
The focus of this project are elderly people who have experienced hip fracture and need at least two weeks rehabilitation after discharge from hospital. The aim is to increase the evidence-based knowledge base for planning and appropriate follow-up intervention for patients with hip fracture on short-term / rehabilitation stays. In this study the investigators want to explore whether training High Intensity Functional Exercises (HIFE) , of short duration ie a 2- 4 week program and frequent intervention ie 5 times per week has a significant positive effect on physical function, pain and quality of life. The main aim is to explore whether a high intensive strength and balance training program has better effect than a low intensive strength and balance training program on functional status measured by Short Physical Performance Battery (SPPB) in patients with hip fractures. Another aims is to explore whether this high intensive strength and balance training program has better effect than a 'low intensive strength and balance training program' on pain, endurance and quality of life measured respectively Numeric Pain Rating Scale (NPR), 6-minute walk test and SF-36. The study is a randomized controlled trial.
- Conditions
- Hip Fracture
- Being tested
- High intensity functional exercise, Low intensity functional exercise
- Keywords
- Physiotherapy, hip fracture, rehabilitation, high dose exercise, low dose exercise
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity functional exerciseOther
Low intensity functional exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Low dose exercise intervention | Active comparator | Not described Receives: Other: Low intensity functional exercise |
| High dose exercise intervention | Experimental | Not described Receives: Other: High intensity functional exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Short Physical Performance Battery
Measured: November 2015 -October 2018 (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2021
- Study completionOct 2021
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 FractureStudies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Braseth rehabilitation centre
- Responsible party
- Principal investigator, Astrid Bergland, Oslo Metropolitan University
- Investigators
- Astrid Bergland, PhD, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815254
- Sponsor's protocol ID
- 2014/1441
- Status last verified
- Oct 2022
- First submitted
- 21 Apr 2015
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- 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 36070134
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise in Elderly Hip Fracture Patients: a Clinical Randomised Trial
- ClinicalTrials.gov ID
- NCT02815254
- Acronym / sponsor ID
- 2014/1441
- Conditions
- Hip Fracture
- Keywords
- Physiotherapy, hip fracture, rehabilitation, high dose exercise, low dose exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Braseth rehabilitation centre
- Study start
- Nov 2015
- Primary completion
- Oct 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 28 Jun 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 focus of this project are elderly people who have experienced hip fracture and need at least two weeks rehabilitation after discharge from hospital. The aim is to increase the evidence-based knowledge base for planning and appropriate follow-up intervention for patients with hip fracture on short-term / rehabilitation stays. In this study the investigators want to explore whether training High Intensity Functional Exercises (HIFE) , of short duration ie a 2- 4 week program and frequent intervention ie 5 times per week has a significant positive effect on physical function, pain and quality of life. The main aim is to explore whether a high intensive strength and balance training program has better effect than a low intensive strength and balance training program on functional status measured by Short Physical Performance Battery (SPPB) in patients with hip fractures. Another aims is to explore whether this high intensive strength and balance training program has better effect than a 'low intensive strength and balance training program' on pain, endurance and quality of life measured respectively Numeric Pain Rating Scale (NPR), 6-minute walk test and SF-36. The study is a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose exercise intervention | Active comparator | Other: Low intensity functional exercise |
| High dose exercise intervention | Experimental | Other: High intensity functional exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Fractura colli femoris, pertrochantar or subtrochantar)
- Discharged from hospital within 3 weeks since surgery.
- Need of minimum two weeks rehabilitation
- Life expectancy of more than one month
- Able to walk at least 3 m with walking aid
Key exclusion criteria (1 listed)
- -Other reasons for gait impairment than hip fracture
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 |
|---|---|---|
| High intensity functional exercise | Other | High dose exercise intervention |
| Low intensity functional exercise | Other | Low dose exercise intervention |
Primary outcome
The Short Physical Performance Battery
Time frame: November 2015 -October 2018 (up to 3 years)
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 6 Oct 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.
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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.
Astrid Bergland, PhD principal investigator
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity functional exercise and Low intensity functional exercise in people with Hip Fracture, run by Oslo Metropolitan University 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 8 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: finished, as of the sponsor's last update on 6 Oct 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 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?
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?
The Short Physical Performance Battery (time frame: November 2015 -October 2018 (up to 3 years)). 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 NCT02815254, 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 6 Oct 2022.