Hemophilia AHEPSNCT02199717

An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia

An observational study of Hemophilia A and Hemophilia B, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 17 years, men only
Conditions the study is for: Hemophilia A, Hemophilia B, Factor VIII Deficiency
What is being tested?: Accelerometer
Type of treatment: Medical device
How many people: 66 participants
Where: 1 siteCanada
Study dates: Sep 2013to Sep 2016
How long will I take part?: 7 Days
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 17 years
Men only
No healthy volunteers
Child

Study population: Patients will be 5 to 18 years of age with a diagnosis of hemophilia with no history of inhibitors or pre-existing co-morbidity (e.g. cerebral palsy, chronic respiratory conditions, congenital heart defects) that can affect activity participation.

Who may be able to join

5-17 years of age, has a diagnosis of Hemophilia A or B.

Who cannot join

Muscle or joint bleed within 4 weeks of study.
Pre-existing co-morbidities that would affect physical activity participation.
Unable to cooperate with study protocol.
Unable to speak, read, or understand English.

Trial locations and contacts

1 site in 1 country.

Canada1 site

SickKids
Toronto, Ontario, M5G1X8

Other trials in Canada

About this study

This pilot project was developed to investigate subjective and objective data related to the patterns of physical activity participation among hemophilia patients (FVIII or FIX) between the ages of 5 and 18 years. Physical activity participation among different levels of disease severity will be compared using accelerometers to calculate the amount of time spent in moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA; additionally, data will be collected from two validated questionnaires (PedHAL and 3 day physical activity recall). Current literature that relates level of physical activity to disease severity in the pediatric hemophilia population is limited. The information gained about the type and quantity of physical activity participation in children with varying levels of hemophilia will assist in the development of education and interventions to promote good physical activity and potentially examine the role of tailored prophylaxis.

Read the detailed description

Objectives:

To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.
To determine if recorded physical activities and intensity of activities from self-report questionnaires (PedHAL and 3 day physical activity recall - 3DPAR) differ according to the severity of hemophilia.
To determine if, among patients with hemophilia, there is a relationship between physical activity level and patient age, weight, and body mass index (BMI).

Specific Aims:

•Aim # 1: The primary aim of the study is to determine if there are differences in the amount of time spent in MVPA by level of disease severity of children with hemophilia.

Secondary Aims:

Aim # 2: To determine if there are meaningful differences in the accumulation of MVPA (bouts of exercise) by disease severity of children with hemophilia.
Aim # 3: The compare the findings from Aim #1 and #2 to the NHANES (National Health and Nutrition Examination Survey) data, recognizing that this survey provides a comparative healthy normal cohort.
Aim # 4: To investigate MVPA with these data collected from the PedHAL (11) and the 3DPAR (12) by disease severity of children with hemophilia.
Aim # 5: The review and determine the relationship between physical activity participation and timing of prophylaxis factor replacement and whether participation is limited to days of factor infusion.
Aim #6: To investigate the amount of physical activity and how it relates to age, weight, and patient body mass index (BMI).

Conditions: Hemophilia A, Hemophilia B, Factor VIII Deficiency, Factor IX Deficiency
Being tested: Accelerometer
Keywords: Physical Activity, Accelerometer, Exercise, Obesity, BMI
Medical subject headings: Hemophilia A, Hemophilia B, Motor Activity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AccelerometerDevice
Also called ActiLife, Kinesoft

Study groups in NCT02199717
Study group	Role	What they receive
Boys with Hemophilia		Accelerometer use for 1 week. Receives: Device: Accelerometer

What is being measured

The primary outcome is the main question the study is designed to answer.

MVPA
To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.
Measured: 7 days
Sedentary Time
To determine if the amount of time spent in sedentary time on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Sep 2016

First posted24 Jul 2014 (estimated)
Study startSep 2013
Primary completionJul 2014
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hemophilia AStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 66 participants (actual)
Target duration: 7 Days

IDs, dates and publications

ClinicalTrials.gov ID: NCT02199717
Sponsor's protocol ID: 1000039947
Acronym: HEPS
Status last verified: Dec 2016
First submitted: 23 Jul 2014
Last updated: 14 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
A Study to Describe Patient REal-world FitusiRan ExpeRience
Hemophilia A or B
RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
RecruitingObservational study
An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
Hemophilia A
RecruitingPhase 3
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
Hemophilia A
Active, not recruitingPhase 4
A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis
Severe Hemophilia A, Moderate Hemophilia A

All Hemophilia A trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia
ClinicalTrials.gov ID: NCT02199717
Acronym / sponsor ID: HEPS / 1000039947
Conditions: Hemophilia A, Hemophilia B, Factor VIII Deficiency, Factor IX Deficiency
Keywords: Physical Activity, Accelerometer, Exercise, Obesity, BMI
Study type: Observational
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: The Hospital for Sick ChildrenUniversity, hospital or other
Collaborators: Canadian Hemophilia Society
Study start: Sep 2013
Primary completion: Jul 2014 (actual)
Study completion: Sep 2016 (actual)
First posted: 24 Jul 2014 (estimated)
Results: Posted 14 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objectives:

To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.
To determine if recorded physical activities and intensity of activities from self-report questionnaires (PedHAL and 3 day physical activity recall - 3DPAR) differ according to the severity of hemophilia.
To determine if, among patients with hemophilia, there is a relationship between physical activity level and patient age, weight, and body mass index (BMI).

Specific Aims:

•Aim # 1: The primary aim of the study is to determine if there are differences in the amount of time spent in MVPA by level of disease severity of children with hemophilia.

Secondary Aims:

Aim # 2: To determine if there are meaningful differences in the accumulation of MVPA (bouts of exercise) by disease severity of children with hemophilia.
Aim # 3: The compare the findings from Aim #1 and #2 to the NHANES (National Health and Nutrition Examination Survey) data, recognizing that this survey provides a comparative healthy normal cohort.
Aim # 4: To investigate MVPA with these data collected from the PedHAL (11) and the 3DPAR (12) by disease severity of children with hemophilia.
Aim # 5: The review and determine the relationship between physical activity participation and timing of prophylaxis factor replacement and whether participation is limited to days of factor infusion.
Aim #6: To investigate the amount of physical activity and how it relates to age, weight, and patient body mass index (BMI).

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 7 Days
Number of arms: 1

Arm	Type	Receives
Boys with Hemophilia	–	Device: AccelerometerAccelerometer use for 1 week.

Who may qualify

Ages: 5 to 17 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child
Study population: Patients will be 5 to 18 years of age with a diagnosis of hemophilia with no history of inhibitors or pre-existing co-morbidity (e.g. cerebral palsy, chronic respiratory conditions, congenital heart defects) that can affect activity participation.

Key inclusion criteria (1 listed)

5-17 years of age, has a diagnosis of Hemophilia A or B.

Key exclusion criteria (4 listed)

Muscle or joint bleed within 4 weeks of study.
Pre-existing co-morbidities that would affect physical activity participation.
Unable to cooperate with study protocol.
Unable to speak, read, or understand English.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AccelerometerAlso: ActiLife, Kinesoft	Device	Boys with Hemophilia

Primary outcome

MVPA
Time frame: 7 days
To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.
Sedentary Time
Time frame: 7 days
To determine if the amount of time spent in sedentary time on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.

Results and safety

Results posted to the registry on 14 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Boys With Hemophilia	66	66

Primary outcome: MVPA

Time frame: 7 days. Mean (Standard Deviation). Unit: minutes per day

Measure	Severe Hemophilia n = 42	Mild/Moderate Hemophilia n = 24
Value	48 (20)	55 (18)

Severe Hemophilia: p = 0.32, Wilcoxon (Mann-Whitney)

Population analysed: All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.

Primary outcome: Sedentary Time

Time frame: 7 days. Mean (Standard Deviation). Unit: minutes per day

Measure	Severe Hemophilia n = 42	Mild/Moderate Hemophilia n = 24
Value	633.4 (121.3)	327 (78.73)

Severe Hemophilia vs Mild/Moderate Hemophilia: Mean Difference (Final Values): 306.4 (95% CI 254.8 to 358), p <0.01, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: Adverse events were documented for the duration of study for each participant (duration being 1 week).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Severe Hemophilia	0 of 66 (0%)	0 of 66 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hemophilia A

Not yet recruitingObservational study
A Study to Describe Patient REal-world FitusiRan ExpeRience
Hemophilia A or B
RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
RecruitingObservational study
An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
Hemophilia A
RecruitingPhase 3
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
Hemophilia A
Active, not recruitingPhase 4
A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis
Severe Hemophilia A, Moderate Hemophilia A

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vanessa Bouskill, NP, MN principal investigator

The Hospital for Sick Children

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hemophilia A and Hemophilia B, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MVPA (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02199717.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.