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

Hemophilia A Without Inhibitor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04181697
• Other study ID #: 2019/549
• Status: Completed
• Start date: November 5, 2019
• Est. completion date: August 27, 2020

Study information

• Verified date: November 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 27, 2020
• Est. primary completion date: August 27, 2020
• Gender: Male
• Age group: 13 Years to 30 Years

Eligibility

Inclusion Criteria:

• moderate or severe haemophilia A
• no inhibitor
• on continuous prophylaxis

Exclusion Criteria:

• current inhibitor

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia A Without Inhibitor

Intervention

Device:
• PA measurement with Fitbit Charge 3
Measurement of PA with Fitbit for all participants and controls.
• PA measurement with Fitbit and ActiGraph GT3X
Measurement of PA with ActiGraph for a subgroup of 20 participants.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian School of Sport Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity (PA) volume	PA volume in different intensities	9 months
Primary	Fulfilment of PA recommendations	Fulfilment of international PA recommendations	9 months
Primary	Trend in PA over time	Trend in PA and sedentary time over the study period	9 months
Primary	Physical activity types	Self reported types of PA	9 months
Secondary	Impact of haemophilia on daily life	Work and Classroom Productivity and Activity Impairment (WPAI+CIQ:HS)	9 months
Secondary	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
Secondary	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
Secondary	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