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

NCT04181697 | Completed

• 1 other identifier: 2019/549
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia A Without Inhibitor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Impact of haemophilia on daily life

  9 months

• Health Related Quality of Life

  9 months

• Joint score

  9 months

• Ultrasound joint score

  9 months

Study Arms (2)

PwH A

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

Device: PA measurement with Fitbit Charge 3; Device: PA measurement with Fitbit and ActiGraph GT3X

Controls

Demographically and seasonally matched non-haemophilia controls.

Device: PA measurement with Fitbit Charge 3

Interventions

PA measurement with Fitbit Charge 3 DEVICE

Measurement of PA with Fitbit for all participants and controls.

Controls; PwH A

PA measurement with Fitbit and ActiGraph GT3X DEVICE

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

PwH A

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: male
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• current inhibitor

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian School of Sport Sciences: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor of Haematology

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 29, 2019
• Study Start: November 5, 2019
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)