- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00281333
The Influence of "Karate" on Bleeding in Hemophilic Patients.
August 28, 2011 updated by: Sheba Medical Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Severe Hemophilia.
Exclusion Criteria:
- No Inhibitors.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Uri Martinowitz, M.D., Sheba Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
January 23, 2006
First Submitted That Met QC Criteria
January 23, 2006
First Posted (Estimate)
January 24, 2006
Study Record Updates
Last Update Posted (Estimate)
August 30, 2011
Last Update Submitted That Met QC Criteria
August 28, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-02-2708-UM-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.