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

NCT ID: NCT04181697

Last Updated: 2020-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-05

Study Completion Date

2020-08-27

Brief Summary

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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

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Conditions

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Hemophilia A Without Inhibitor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PwH A

People with Haemophilia (PwH) A, moderate or severe.

PA measurement with Fitbit Charge 3

Intervention Type DEVICE

Measurement of PA with Fitbit for all participants and controls.

PA measurement with Fitbit and ActiGraph GT3X

Intervention Type DEVICE

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

Controls

Demographically and seasonally matched non-haemophilia controls.

PA measurement with Fitbit Charge 3

Intervention Type DEVICE

Measurement of PA with Fitbit for all participants and controls.

Interventions

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PA measurement with Fitbit Charge 3

Measurement of PA with Fitbit for all participants and controls.

Intervention Type DEVICE

PA measurement with Fitbit and ActiGraph GT3X

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* current inhibitor
Minimum Eligible Age

13 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Norwegian School of Sport Sciences

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pål Andre Holme

MD, PhD, Professor of Haematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2019/549

Identifier Type: -

Identifier Source: org_study_id