HemFitBit, an Observational Study of Physical Activity in People With Moderate and Severe Haemophilia A
- Conditions
- Hemophilia A Without Inhibitor
- Interventions
- Device: PA measurement with Fitbit Charge 3Device: PA measurement with Fitbit and ActiGraph GT3X
- Registration Number
- NCT04181697
- Lead Sponsor
- Oslo University Hospital
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
- moderate or severe haemophilia A
- no inhibitor
- on continuous prophylaxis
- current inhibitor
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Controls PA measurement with Fitbit Charge 3 Demographically and seasonally matched non-haemophilia controls. PwH A PA measurement with Fitbit and ActiGraph GT3X People with Haemophilia (PwH) A, moderate or severe. PwH A PA measurement with Fitbit Charge 3 People with Haemophilia (PwH) A, moderate or severe.
- Primary Outcome Measures
Name Time Method Physical Activity (PA) volume 9 months PA volume in different intensities
Physical activity types 9 months Self reported types of PA
Fulfilment of PA recommendations 9 months Fulfilment of international PA recommendations
Trend in PA over time 9 months Trend in PA and sedentary time over the study period
- Secondary Outcome Measures
Name Time Method Impact of haemophilia on daily life 9 months Work and Classroom Productivity and Activity Impairment (WPAI+CIQ:HS)
Health Related Quality of Life 9 months 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".
Joint score 9 months 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.
Ultrasound joint score 9 months 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.
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway