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Completed

NCT Number: NCT04181697

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

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Key information

Age range

13 year–30 year

Sex eligibility

Male

Study type

Observational

Primary location

Oslo University Hospital

Oslo, Norway

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • current inhibitor

Treatment and study plan

PA measurement with Fitbit Charge 3

Device

Measurement of PA with Fitbit for all participants and controls.

PA measurement with Fitbit and ActiGraph GT3X

Device

Measurement of PA with ActiGraph for a subgroup of 20 participants.

Primary outcomes

  1. Physical Activity (PA) volume

    Time frame: 9 months

    PA volume in different intensities

  2. Fulfilment of PA recommendations

    Time frame: 9 months

    Fulfilment of international PA recommendations

  3. Trend in PA over time

    Time frame: 9 months

    Trend in PA and sedentary time over the study period

  4. Physical activity types

    Time frame: 9 months

    Self reported types of PA

Secondary outcomes

  1. Impact of haemophilia on daily life

    Time frame: 9 months

    Work and Classroom Productivity and Activity Impairment (WPAI+CIQ:HS)

  2. Health Related Quality of Life

    Time frame: 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".

  3. Joint score

    Time frame: 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.

  4. Ultrasound joint score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian School of Sport Sciences

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2019
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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