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

• ClinicalTrials.gov Identifier: NCT04181697
• Recruitment Status: Completed
• First Posted: November 29, 2019
• Last Update Posted: November 30, 2020
• Sponsor: Oslo University Hospital
• Collaborator: Norwegian School of Sport Sciences
• Information provided by (Responsible Party): Pål Andre Holme, Oslo University Hospital

Tracking Information

• First Submitted Date: November 25, 2019
• First Posted Date: November 29, 2019
• Last Update Posted Date: November 30, 2020
• Actual Study Start Date: November 5, 2019
• Actual Primary Completion Date: August 27, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 1, 2020)

• Physical Activity (PA) volume [ Time Frame: 9 months ]
  PA volume in different intensities
• Fulfilment of PA recommendations [ Time Frame: 9 months ]
  Fulfilment of international PA recommendations
• Trend in PA over time [ Time Frame: 9 months ]
  Trend in PA and sedentary time over the study period
• Physical activity types [ Time Frame: 9 months ]
  Self reported types of PA

Original Primary Outcome Measures (submitted: November 26, 2019)

• Physical activity volume [ Time Frame: 9 months ]
  PA volume in different intensities
• Fulfilment of PA recommendations [ Time Frame: 9 months ]
  Fulfilment of international PA recommendations
• Trend in PA over time [ Time Frame: 9 months ]
  Trend in PA and sedentary time over the study period
• Physical activity types [ Time Frame: 9 months ]
  Self reported types of PA

Current Secondary Outcome Measures (submitted: April 1, 2020)

• Impact of haemophilia on daily life [ Time Frame: 9 months ]
  Work and Classroom Productivity and Activity Impairment (WPAI+CIQ:HS)
• 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".
• 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.
• 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.

Original Secondary Outcome Measures (submitted: November 26, 2019)

• Impact of haemophilia on daily life [ Time Frame: 9 months ]
  Work and Classroom Productivity and Activity Impairment (WPAI+CIQ:HS)
• Health Related Quality of Life [ Time Frame: 9 months ]
  EQ-5D-3L
• Joint score [ Time Frame: 9 months ]
  HJHS 2.1
• Ultrasound joint score [ Time Frame: 9 months ]
  HEAD-US

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HemFitBit, an Observational Study of Physical Activity in People With Moderate and Severe Haemophilia A
• Official Title: The HemFitBit-study: Defining Normal Physical Activity in Haemophilia A
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Hemophilia A Without Inhibitor

Intervention

• 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.

Study Groups/Cohorts

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

  • Device: PA measurement with Fitbit Charge 3
  • Device: PA measurement with Fitbit and ActiGraph GT3X
• Controls
  Demographically and seasonally matched non-haemophilia controls.
  Intervention: Device: PA measurement with Fitbit Charge 3

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 26, 2019): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 27, 2020
• Actual Primary Completion Date: August 27, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• current inhibitor

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 13 Years to 30 Years (Child, Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT04181697
• Other Study ID Numbers: 2019/549
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Pål Andre Holme, Oslo University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Oslo University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Norwegian School of Sport Sciences
• Investigators: Not Provided
• PRS Account: Oslo University Hospital
• Verification Date: November 2020