Hemophilia A Without InhibitorNCT04181697
HemFitBit, an Observational Study of Physical Activity in People With Moderate and Severe Haemophilia A
An observational study of Hemophilia A Without Inhibitor, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The study aims to describe physical activity (PA) levels in young people with haemophilia A in Norway compared with non-haemophilia controls, and to identify factors influencing PA. This will be conducted through an observational study measuring PA over 12 weeks. Read more about this study
- Who is it for?
- Ages 13 to 30 years, men only
- Conditions the study is for
- Hemophilia A Without Inhibitor
- What is being tested?
- PA measurement with Fitbit Charge 3 and PA measurement with Fitbit and ActiGraph GT3X
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- 5 Nov 2019to 27 Aug 2020
- Phase
- Observational
- 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 13 to 30 years
- Men only
- Child, Adult
Study population: Young people with moderate and severe haemophilia A, without inhibitors and on continuous prophylaxis will be identified from the national registry of PwH.
Who may be able to join
- moderate or severe haemophilia A
- no inhibitor
- on continuous prophylaxis
Who cannot join
- current inhibitor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The HemFitBit-study: Defining Normal Physical Activity in Haemophilia A
The study aims to describe physical activity (PA) levels in young people with haemophilia A in Norway compared with non-haemophilia controls, and to identify factors influencing PA. This will be conducted through an observational study measuring PA over 12 weeks. Forty young people with moderate and severe haemophilia A will be enrolled. PA data will be compared to demographically and seasonally matched non-haemophilia controls. PA will be measured using the activity tracker Fitbit Charge 3. A subgroup of participants will also wear the hip-worn accelerometer ActiGraph GTX+BT for seven consecutive days in order to validate the two devices against each other.
- Conditions
- Hemophilia A Without Inhibitor
- Being tested
- PA measurement with Fitbit Charge 3, PA measurement with Fitbit and ActiGraph GT3X
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA measurement with Fitbit Charge 3Device
Measurement of PA with Fitbit for all participants and controls.
PA measurement with Fitbit and ActiGraph GT3XDevice
Measurement of PA with ActiGraph for a subgroup of 20 participants.
| Study group | Role | What they receive |
|---|---|---|
| PwH A | People with Haemophilia (PwH) A, moderate or severe. Receives: Device: PA measurement with Fitbit Charge 3; Device: PA measurement with Fitbit and ActiGraph GT3X | |
| Controls | Demographically and seasonally matched non-haemophilia controls. Receives: Device: PA measurement with Fitbit Charge 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity (PA) volume
PA volume in different intensities
Measured: 9 months
Fulfilment of PA recommendations
Fulfilment of international PA recommendations
Measured: 9 months
Trend in PA over time
Trend in PA and sedentary time over the study period
Measured: 9 months
Physical activity types
Self reported types of PA
Measured: 9 months
Secondary outcomes (4)
Impact of haemophilia on daily life
Work and Classroom Productivity and Activity Impairment (WPAI+CIQ:HS)
Measured: 9 months
Health Related Quality of Life
EuroQol 5Domains 3Levels (EQ-5D-3L) Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using a three-level scale, and evaluate their overall health status using a Visual analogue scale (VAS) where the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".
Measured: 9 months
Joint score
Hemophilia Joint Health Score (HJHS 2.1) The Hemophilia Joint Health Score (HJHS) is a validated outcome tool developed for the assessment of joint health in people with hemophilia. The ordinal joint score assesses 9 items in 6 index joints (elbows, knees and ankles). It assesses swelling, duration of swelling, muscle atrophy, crepitus of motion, range of motion (extension and flexion loss), joint pain, strength, and gait. The summation of the 9 HJHS items in 6 index joints provides users with a relative indicator of joint health, with a lower HJHS representing superior joint health.
Measured: 9 months
Ultrasound joint score
Hemophilia Early Arthropathy Detection using Ultrasound (HEAD-US) The ultrasound protocal evaluates the six joints most typically affected in PwH: the elbows, knees, and ankles, in one single examination, providing information about synovium, cartilage, and subchondral bone. Scores for each joint can range between 0 and 8, with higher scores indicating more severe abnormalities.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start5 Nov 2019
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia A Without InhibitorStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Responsible party
- Principal investigator, Pål Andre Holme, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181697
- Sponsor's protocol ID
- 2019/549
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HemFitBit-study: Defining Normal Physical Activity in Haemophilia A
- ClinicalTrials.gov ID
- NCT04181697
- Acronym / sponsor ID
- 2019/549
- Conditions
- Hemophilia A Without Inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian School of Sport Sciences
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 29 Nov 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.
The study aims to describe physical activity (PA) levels in young people with haemophilia A in Norway compared with non-haemophilia controls, and to identify factors influencing PA. This will be conducted through an observational study measuring PA over 12 weeks. Forty young people with moderate and severe haemophilia A will be enrolled. PA data will be compared to demographically and seasonally matched non-haemophilia controls. PA will be measured using the activity tracker Fitbit Charge 3. A subgroup of participants will also wear the hip-worn accelerometer ActiGraph GTX+BT for seven consecutive days in order to validate the two devices against each other.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PwH A | – | Device: PA measurement with Fitbit Charge 3, Device: PA measurement with Fitbit and ActiGraph GT3XPeople with Haemophilia (PwH) A, moderate or severe. |
| Controls | – | Device: PA measurement with Fitbit Charge 3Demographically and seasonally matched non-haemophilia controls. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- Male only
- Age groups
- Child, Adult
- Study population
- Young people with moderate and severe haemophilia A, without inhibitors and on continuous prophylaxis will be identified from the national registry of PwH.
Key inclusion criteria (3 listed)
- moderate or severe haemophilia A
- no inhibitor
- on continuous prophylaxis
Key exclusion criteria (1 listed)
- current 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 |
|---|---|---|
| PA measurement with Fitbit Charge 3Measurement of PA with Fitbit for all participants and controls. | Device | Controls, PwH A |
| PA measurement with Fitbit and ActiGraph GT3XMeasurement of PA with ActiGraph for a subgroup of 20 participants. | Device | PwH A |
Primary outcome
Physical Activity (PA) volume
Time frame: 9 months
PA volume in different intensities
Fulfilment of PA recommendations
Time frame: 9 months
Fulfilment of international PA recommendations
Trend in PA over time
Time frame: 9 months
Trend in PA and sedentary time over the study period
Physical activity types
Time frame: 9 months
Self reported types of PA
4 secondary outcomes
Impact of haemophilia on daily life
Time frame: 9 months
Health Related Quality of Life
Time frame: 9 months
Joint score
Time frame: 9 months
Ultrasound joint score
Time frame: 9 months
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 30 Nov 2020.
- 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.
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?
An observational study of Hemophilia A Without Inhibitor, run by Oslo University Hospital 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 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 30 Nov 2020. 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?
Physical Activity (PA) volume (time frame: 9 months). The study lists 4 primary outcomes in all. 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 30 Nov 2020.