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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04181697
Recruitment Status : Completed
First Posted : November 29, 2019
Last Update Posted : November 30, 2020
Sponsor:
Collaborator:
Norwegian School of Sport Sciences
Information provided by (Responsible Party):
Pål Andre Holme, Oslo University Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Hemophilia A Without Inhibitor Device: PA measurement with Fitbit Charge 3 Device: PA measurement with Fitbit and ActiGraph GT3X

Study Design
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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The HemFitBit-study: Defining Normal Physical Activity in Haemophilia A
Actual Study Start Date : November 5, 2019
Actual Primary Completion Date : August 27, 2020
Actual Study Completion Date : August 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 30 Years   (Child, Adult)
Sexes 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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • current inhibitor
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04181697


Locations
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Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Norwegian School of Sport Sciences
More Information
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Responsible Party: Pål Andre Holme, MD, PhD, Professor of Haematology, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04181697    
Other Study ID Numbers: 2019/549
First Posted: November 29, 2019    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn