HemophiliaNCT03842605
Efficacy of Strength Training in Improving Elbow Range of Motion and Function in Adults With Hemophilia
A study testing Strength training in people with Hemophilia and Elbow Joint Contracture, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a research study of adults with hemophilia that have limitations in elbow joint motion that is the result of bleeding into the joint. People with hemophilia who have bleeding into their elbow joint may have limitations in elbow joint movement and pain in the joint. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemophilia, Elbow Joint Contracture
- What is being tested?
- Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 13 Feb 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of the Oregon health and Science University Hemophilia treatment Center
- greater or equal to 18 years old
- Loss of elbow range of motion that is greater than or equal to 5 degrees
Who cannot join
- Present inhibitor
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239-3098
About this study
This is a research study of adults with hemophilia that have limitations in elbow joint motion that is the result of bleeding into the joint.
People with hemophilia who have bleeding into their elbow joint may have limitations in elbow joint movement and pain in the joint. This research is being done to determine the effect a strength training program has on the amount of movement people with hemophilia and elbow joint disease have.
- Conditions
- Hemophilia, Elbow Joint Contracture
- Being tested
- Strength training
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Experimental | Not described Receives: Other: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow range of motion
measurement of change of range of motion over time frame
Measured: measurements to be taken at 4 and 8 weeks after entering study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study startOct 2012
- Primary completionFeb 2019
- Study completion13 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Oleson, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842605
- Sponsor's protocol ID
- 09062
- Status last verified
- Feb 2019
- First submitted
- 20 Apr 2013
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Strength Training in Improving Elbow Range of Motion and Function in Adults With Hemophilia
- ClinicalTrials.gov ID
- NCT03842605
- Acronym / sponsor ID
- 09062
- Conditions
- Hemophilia, Elbow Joint Contracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2019 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 15 Feb 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.
This is a research study of adults with hemophilia that have limitations in elbow joint motion that is the result of bleeding into the joint.
People with hemophilia who have bleeding into their elbow joint may have limitations in elbow joint movement and pain in the joint. This research is being done to determine the effect a strength training program has on the amount of movement people with hemophilia and elbow joint disease have.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Strength training | Experimental | Other: Strength training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of the Oregon health and Science University Hemophilia treatment Center
- greater or equal to 18 years old
- Loss of elbow range of motion that is greater than or equal to 5 degrees
Key exclusion criteria (1 listed)
- Present inhibitor
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 |
|---|---|---|
| Strength training | Other | Strength training |
Primary outcome
Elbow range of motion
Time frame: measurements to be taken at 4 and 8 weeks after entering study
measurement of change of range of motion over time frame
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 15 Feb 2019.
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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 Strength training in people with Hemophilia and Elbow Joint Contracture, run by Oregon Health and Science University at 1 site in United States.
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 3 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 15 Feb 2019. 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 United States. 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?
Elbow range of motion (time frame: measurements to be taken at 4 and 8 weeks after entering study). 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 15 Feb 2019.