Trial Outcomes & Findings for An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia (NCT NCT02199717)

NCT ID: NCT02199717

Last Updated: 2016-12-14

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

66 participants

Primary outcome timeframe

7 days

Results posted on

2016-12-14

Participant Flow

Participant milestones

Participant milestones
Measure	Boys With Hemophilia Use of accelerometer for 1 week
Overall Study STARTED	66
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BMI was grouped by hemophilia severity.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Boys With Hemophilia n=66 Participants
Age, Customized <=18 years	66 participants n=66 Participants
Age, Customized Between 18 and 65 years	0 participants n=66 Participants
Age, Customized >=65 years	0 participants n=66 Participants
Sex/Gender, Customized Female	0 Participants n=66 Participants
Sex/Gender, Customized Male	66 Participants n=66 Participants
Region of Enrollment Canada	66 participants n=66 Participants
BMI Severe Hemophilia	20.05 kg/m2 STANDARD_DEVIATION 5.82 • n=42 Participants • BMI was grouped by hemophilia severity.
BMI Mild/Moderate Hemophilia	21.93 kg/m2 STANDARD_DEVIATION 5.34 • n=24 Participants • BMI was grouped by hemophilia severity.
On demand or Prophylaxis Regimen Severe Hemophilia · On prophylaxis	42 Participants n=42 Participants • Grouped by hemophilia severity.
On demand or Prophylaxis Regimen Severe Hemophilia · On demand	0 Participants n=42 Participants • Grouped by hemophilia severity.
On demand or Prophylaxis Regimen Mild/Moderate Hemophilia · On prophylaxis	5 Participants n=24 Participants • Grouped by hemophilia severity.
On demand or Prophylaxis Regimen Mild/Moderate Hemophilia · On demand	19 Participants n=24 Participants • Grouped by hemophilia severity.
Severity of Hemophilia Severe	42 Participants n=66 Participants
Severity of Hemophilia Mild/Moderate	24 Participants n=66 Participants

PRIMARY outcome

Timeframe: 7 days

Population: 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.

Outcome measures

Outcome measures
Measure	Severe Hemophilia n=42 Participants Severe Hemophilia	Mild/Moderate Hemophilia n=24 Participants Mild/Moderate Hemophilia
MVPA	48 minutes per day Standard Deviation 20	55 minutes per day Standard Deviation 18

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Severe Hemophilia n=42 Participants Severe Hemophilia	Mild/Moderate Hemophilia n=24 Participants Mild/Moderate Hemophilia
Sedentary Time	633.4 minutes per day Standard Deviation 121.3	327 minutes per day Standard Deviation 78.73

Adverse Events

Severe Hemophilia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vanessa Bouskill NP

Hospital for Sick Children

Phone: 4168135871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place