Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02199717
Other study ID # 1000039947
Secondary ID
Status Completed
Phase N/A
First received July 23, 2014
Last updated December 8, 2016
Start date September 2013
Est. completion date September 2016

Study information

Verified date December 2016
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

Objectives:

1. 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.

2. 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.

3. 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).


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date September 2016
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Male
Age group 5 Years to 17 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Device:
Accelerometer


Locations

Country Name City State
Canada SickKids Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
The Hospital for Sick Children Canadian Hemophilia Society

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 7 days No
Primary 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. 7 days No
See also
  Status Clinical Trial Phase
Completed NCT03834727 - Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
Completed NCT03191799 - A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors Phase 3
Completed NCT01599819 - BAX 855 Dose-Escalation Safety Study Phase 1
Terminated NCT04541628 - Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A Phase 1/Phase 2
Completed NCT02847637 - A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors Phase 3
Completed NCT04072237 - Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia Phase 1
Completed NCT04085458 - Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation) Phase 4
Completed NCT04565236 - A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A Phase 4
Recruiting NCT05987449 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A Phase 1/Phase 2
Active, not recruiting NCT04621916 - Preventing Inhibitor Recurrence Indefinitely Phase 4
Not yet recruiting NCT02888223 - Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A Phase 1
Completed NCT02528968 - National Study of a Pharmacokinetic-Focused Educational Package for Patients With Severe Haemophilia A N/A
Completed NCT02225483 - Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function N/A
Completed NCT01217255 - Comparing the Burden of Illness of Hemophilia in the Developing and the Developed World
Completed NCT00969319 - Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America N/A
Terminated NCT00995046 - Individually Tailored Prophylaxis in Patients With Severe Hemophilia A N/A
Completed NCT00868530 - Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects Phase 3
Completed NCT00839202 - Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay N/A
Completed NCT00629837 - Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980 Phase 1
Completed NCT02093741 - ADVATE 2 mL Post-Authorization Safety Surveillance (PASS)