HemFitBit, an Observational Study of Physical Activity in People With Moderate and Severe Haemophilia A

Study Overview
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Brief Summary
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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.

Official Title
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The HemFitBit-study: Defining Normal Physical Activity in Haemophilia A

Conditions
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Hemophilia A Without Inhibitor

Intervention / Treatment
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* Device: PA measurement with Fitbit Charge 3
* Device: PA measurement with Fitbit and ActiGraph GT3X


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate or severe haemophilia A no inhibitor on continuous prophylaxis Exclusion Criteria: current inhibitor

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PwH A<br>People with Haemophilia (PwH) A, moderate or severe. | Device: PA measurement with Fitbit Charge 3<br>* Measurement of PA with Fitbit for all participants and controls.<br>Device: PA measurement with Fitbit and ActiGraph GT3X<br>* Measurement of PA with ActiGraph for a subgroup of 20 participants.<br>|
| Controls<br>Demographically and seasonally matched non-haemophilia controls. | Device: PA measurement with Fitbit Charge 3<br>* Measurement of PA with Fitbit for all participants and controls.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of haemophilia on daily life | Work and Classroom Productivity and Activity Impairment (WPAI+CIQ:HS) | 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. | 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. | 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. | 9 months |