Hip FractureNCT01667913
Reliability of 6-Minutes Walking Test in Hip Fracture Patients
A study testing 6 minutes walking test in people with Hip Fracture, run by Lolland Community, Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the relative (ICC) and absolute intertester reliability of the 6-Minutes Walking Test in hip fracture patients (N=50) in an outpatient facility. The data collection is conducted by two physiotherapists, who are blinded to each other. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- 6 minutes walking test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Aug 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years or above
- Hip fracture patients with a Intra - or Extra Capsular hip fracture
- Testing within 3 - 5 weeks postsurgery in an outpatient facility
- No weightbearing restrictions on the fractured limb
- Normal cognitive level (Mini Mental State Examination(MMSE) - score ≥20 points)
- Participants should not experiencing hip related pain more or less than moderate according to Verbal Ranking Scale when resting
- To have the ability to write and understand danish language
Who cannot join
- MMSE score ≤19 points
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relative and Absolute Reliability of 6-Minutes Walking Test in Hip Fracture Patients
The purpose of this study is to examine the relative (ICC) and absolute intertester reliability of the 6-Minutes Walking Test in hip fracture patients (N=50) in an outpatient facility. The data collection is conducted by two physiotherapists, who are blinded to each other. The physiotherapists are randomized so they each are doing an equal number of baseline tests.
- Conditions
- Hip Fracture
- Being tested
- 6 minutes walking test
- Keywords
- Hip Fracture, 6-minutes walking test, Reliability
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minutes walking testOther
| Study group | Role | What they receive |
|---|---|---|
| 6 minutes walking test | No intervention | Not described Receives: Other: 6 minutes walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 6-Minutes Walking Test
The 6-Minutes Walking Test performed according to International Guidelines, will be performed on hip fracture patients 3 to 5 weeks after surgery. The testing will be conducted on the same person by two physiotherapists with a one day pause in between test sessions.
Measured: 3 to 5 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Due to low inclusion rate we terminated this study with n=20 participants instead of n=50.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lolland Community, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, University of Southern Denmark
- Responsible party
- Principal investigator, Mr. Jan Overgaard, Lolland Community, Denmark
- Investigators
- Jan A Overgaard, Bachelor, Principal investigator, Sector of Health and Older, Department of Rehabilitation, Lolland Community, DenmarkMorten T Kristensen, Ph.d, Study director, Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667913
- Sponsor's protocol ID
- Hip Fracture study 7/7-12
- Status last verified
- Nov 2013
- First submitted
- 15 Aug 2012
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relative and Absolute Reliability of 6-Minutes Walking Test in Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT01667913
- Acronym / sponsor ID
- Hip Fracture study 7/7-12
- Conditions
- Hip Fracture
- Keywords
- Hip Fracture, 6-minutes walking test, Reliability
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low inclusion rate we terminated this study with n=20 participants instead of n=50.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lolland Community, DenmarkUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, University of Southern Denmark
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 Aug 2012 (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 purpose of this study is to examine the relative (ICC) and absolute intertester reliability of the 6-Minutes Walking Test in hip fracture patients (N=50) in an outpatient facility. The data collection is conducted by two physiotherapists, who are blinded to each other. The physiotherapists are randomized so they each are doing an equal number of baseline tests.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6 minutes walking test | No intervention | Other: 6 minutes walking test |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 60 years or above
- Hip fracture patients with a Intra - or Extra Capsular hip fracture
- Testing within 3 - 5 weeks postsurgery in an outpatient facility
- No weightbearing restrictions on the fractured limb
- Normal cognitive level (Mini Mental State Examination(MMSE) - score ≥20 points)
Key exclusion criteria (1 listed)
- MMSE score ≤19 points
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 |
|---|---|---|
| 6 minutes walking test | Other | 6 minutes walking test |
Primary outcome
The 6-Minutes Walking Test
Time frame: 3 to 5 weeks post surgery
The 6-Minutes Walking Test performed according to International Guidelines, will be performed on hip fracture patients 3 to 5 weeks after surgery. The testing will be conducted on the same person by two physiotherapists with a one day pause in between test sessions.
Results and safety
The study was stopped early (reason given: Due to low inclusion rate we terminated this study with n=20 participants instead of n=50.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
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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.
Jan A Overgaard, Bachelor principal investigator
Sector of Health and Older, Department of Rehabilitation, Lolland Community, Denmark
Morten T Kristensen, Ph.d study director
Department of Physical Therapy and Orthopedic Surgery, Copenhagen University Hospital at Hvidovre, 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 6 minutes walking test in people with Hip Fracture, run by Lolland Community, Denmark 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 7 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: stopped early, as of the sponsor's last update on 14 Nov 2013. 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 was stopped early (reason given: Due to low inclusion rate we terminated this study with n=20 participants instead of n=50.). 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?
The 6-Minutes Walking Test (time frame: 3 to 5 weeks post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2013.