NCT04181697|Completed
HemFitBit, an Observational Study of Physical Activity in People With Moderate and Severe Haemophilia A
The HemFitBit-study: Defining Normal Physical Activity in Haemophilia A
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The HemFitBit-study: Defining Normal Physical Activity in Haemophilia A
Sponsor study identifier
observational
40
1 country
1
Study Start
November 5, 2019
Actual (reported)Primary Completion
August 27, 2020
Actual (reported)Study Completion
August 27, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 27, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 5, 2019
Actual (reported)November 25, 2019
Actual (reported)November 29, 2019
Actual (reported)August 27, 2020
Actual (reported)August 27, 2020
Actual (reported)Physical Activity (PA) volume
PA volume in different intensities
9 months
Fulfilment of PA recommendations
Fulfilment of international PA recommendations
9 months
Trend in PA over time
Trend in PA and sedentary time over the study period
9 months
Physical activity types
Self reported types of PA
9 months
Impact of haemophilia on daily life
9 months
Health Related Quality of Life
9 months
Joint score
9 months
Ultrasound joint score
9 months
People with Haemophilia (PwH) A, moderate or severe.
Demographically and seasonally matched non-haemophilia controls.
Measurement of PA with Fitbit for all participants and controls.
Measurement of PA with ActiGraph for a subgroup of 20 participants.
Young people with moderate and severe haemophilia A, without inhibitors and on continuous prophylaxis will be identified from the national registry of PwH.
Oslo University Hospital
Oslo, Norway
40 participants (actual enrollment reported by the registry).
First Submitted
November 25, 2019
First Posted
November 29, 2019
Study Start
November 5, 2019
Actual (reported)Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B Without Inhibitors
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 27, 2020
Actual (reported)Study Completion
August 27, 2020
Actual (reported)Last Updated
November 30, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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