Back to resultsThe Effects of Therapeutic Exercises on Kinesiophobia in Haemophilic Patients.
Primary Purpose
Haemophilia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
therapeutic exercises
Sponsored by
About this trial
This is an interventional treatment trial for Haemophilia
Eligibility Criteria
Inclusion Criteria:
- Individuals older than 18 years
- diagnosed with hemophilia A or B
- having at least one joint with hemophilic arthropathy
- without cognitive problems
- speaking turkish
Exclusion Criteria:
- Individuals with another congenital coagulopathy such as Von Willebrand Syndrome,
- unable to walk due to hemophilic arthropathy
- developing inhibition against factor VIII-IX
Sites / Locations
- Volkan Deniz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
exercises and verbal information
verbal information
Arm Description
therapeutic exercises 3 days in a week and total 8 weeks and 60 minutes verbal information
60 minutes information about effects of exercises on joint functions
Outcomes
Primary Outcome Measures
tampa kinesiophobia scale
This is a questionnaire consisting of a total of 17 questions evaluating fears related to pain or previous injury. participants can receive a maximum of 68 and minimum of 17 points in this questionnaire. there is a negative correlation between the score and kinesiophobia.
haemophilia adult health-related quality of life scale
this questionnaire evaluates health-related quality of life in adult haemophilic individuals and consisting of ten sections -46 questions. participants can receive a maximum of 100 and a minimum of 0 points in this questionnaire. there is a negative correlation between the score and quality of life.
Secondary Outcome Measures
short form-36
short form-36 is a quality of life questionnaire consisting of 8 sections and 36 questions. participants can receive a maximum of 100 and a minimum of 0 points in this questionnaire. there is a positive correlation between the score and quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04205188
Brief Title
The Effects of Therapeutic Exercises on Kinesiophobia in Haemophilic Patients.
Official Title
Do Therapeutic Exercises Improve Kinesiophobia and Health-Related Quality of Life in Adult Haemophilia Patients? A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 13, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Volkan Deniz, PT
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
this study evaluates the effects of therapeutic exercises on kinesiophobia and health-related quality of life in adult haemophilia patients. half of participants will receive therapeutic exercises and verbal information about the positive effects of therapeutic exercises on physical pathologies due to hemophilic arthropathy while the other half will receive only verbal information.
Detailed Description
in haemophilia patients recurrent musculoskeletal hemorrhage cause to arthropathy characterized by severe degeneration of joint cartilage and bones. arthropathy leads to decrease in the patient's health related quality of life. furthermore pain, risk of injury and lack of motivation lead to decreased physical activity and development of kinesiophobia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercises and verbal information
Arm Type
Experimental
Arm Description
therapeutic exercises 3 days in a week and total 8 weeks and 60 minutes verbal information
Arm Title
verbal information
Arm Type
No Intervention
Arm Description
60 minutes information about effects of exercises on joint functions
Intervention Type
Other
Intervention Name(s)
therapeutic exercises
Intervention Description
aerobic- balance -stretching and strengthening exercises
Primary Outcome Measure Information:
Title
tampa kinesiophobia scale
Description
This is a questionnaire consisting of a total of 17 questions evaluating fears related to pain or previous injury. participants can receive a maximum of 68 and minimum of 17 points in this questionnaire. there is a negative correlation between the score and kinesiophobia.
Time Frame
baseline, 8 weeks: change from baseline kinesiophobia at 8 weeks, 6 months: change from baseline kinesiophobia at 6 months
Title
haemophilia adult health-related quality of life scale
Description
this questionnaire evaluates health-related quality of life in adult haemophilic individuals and consisting of ten sections -46 questions. participants can receive a maximum of 100 and a minimum of 0 points in this questionnaire. there is a negative correlation between the score and quality of life.
Time Frame
baseline, 8 weeks: change from baseline health-related quality of life at 8 weeks, 6 months: change from baseline health-related quality of life at 6 months
Secondary Outcome Measure Information:
Title
short form-36
Description
short form-36 is a quality of life questionnaire consisting of 8 sections and 36 questions. participants can receive a maximum of 100 and a minimum of 0 points in this questionnaire. there is a positive correlation between the score and quality of life.
Time Frame
baseline, 8 weeks: change from baseline health-related quality of life at 8 weeks, 6 months: change from baseline health-related quality of life at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals older than 18 years
diagnosed with hemophilia A or B
having at least one joint with hemophilic arthropathy
without cognitive problems
speaking turkish
Exclusion Criteria:
Individuals with another congenital coagulopathy such as Von Willebrand Syndrome,
unable to walk due to hemophilic arthropathy
developing inhibition against factor VIII-IX
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volkan Deniz
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Volkan Deniz
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effects of Therapeutic Exercises on Kinesiophobia in Haemophilic Patients.
We'll reach out to this number within 24 hrs