The Influence of "Karate" on Bleeding in Hemophilic Patients.
Primary Purpose
Hemophilia A
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"Karate" exercises and strengthening exercises
Sponsored by
About this trial
This is an interventional prevention trial for Hemophilia A
Eligibility Criteria
Inclusion Criteria: Severe Hemophilia. Exclusion Criteria: No Inhibitors.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00281333
Brief Title
The Influence of "Karate" on Bleeding in Hemophilic Patients.
Official Title
The Influence of "Karate" on Bleeding in Hemophilic Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
logistics
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hemophilia patients tend to lower their physical activity level due to the fear of increasing bleeding episodes. Although recent literature has shown that with routine muscle strengthening and physical activity, the frequency and duration of bleeds was reduced. Our study has built a routine of strength training exercises and karate training. The study is built in two stages, each stage being three months. The participants fill out a bleeding diary that includes information from the previous six months. It includes place of bleed, duration, pain level, spontaneous or traumatic bleed, factor replacement and joint limitation. Before the exercise, the participants are tested for muscle strength and endurance. The bleeding diary will be filled out following the first three months and the second phase as will the muscle strength and endurance. We are hoping to see a drastic reduction of bleeding episodes occurring especially from spontaneous bleeds.
Detailed Description
none - Hemophilia patients tend to lower their physical activity level due to the fear of increasing bleeding episodes. Although recent literature has shown that with routine muscle strengthening and physical activity, the frequency and duration of bleeds was reduced. Our study has built a routine of strength training exercises and karate training. The study is built in two stages, each stage being three months. The participants fill out a bleeding diary that includes information from the previous six months. It includes place of bleed, duration, pain level, spontaneous or traumatic bleed, factor replacement and joint limitation. Before the exercise, the participants are tested for muscle strength and endurance. The bleeding diary will be filled out following the first three months and the second phase as will the muscle strength and endurance. We are hoping to see a drastic reduction of bleeding episodes occurring especially from spontaneous bleeds.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
"Karate" exercises and strengthening exercises
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe Hemophilia.
Exclusion Criteria:
No Inhibitors.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uri Martinowitz, M.D.
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Influence of "Karate" on Bleeding in Hemophilic Patients.
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