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

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 Overview

• Status: Completed
• Conditions: Hemophilia A Without Inhibitor
• Intervention / Treatment: Device: PA measurement with Fitbit Charge 3; Device: PA measurement with Fitbit and ActiGraph GT3X

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• current inhibitor

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Norwegian School of Sport Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): August 27, 2020
• Study Completion (Actual): August 27, 2020

Study Registration Dates

• First Submitted: November 25, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID Numbers: 2019/549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No