The Effects of Therapeutic Exercises on Kinesiophobia in Haemophilic Patients.

July 27, 2021 updated by: Volkan Deniz, PT

Do Therapeutic Exercises Improve Kinesiophobia and Health-Related Quality of Life in Adult Haemophilia Patients? A Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06560
        • Volkan Deniz

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exercises and verbal information
therapeutic exercises 3 days in a week and total 8 weeks and 60 minutes verbal information
Other: therapeutic exercises
aerobic- balance -stretching and strengthening exercises
No Intervention: verbal information
60 minutes information about effects of exercises on joint functions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tampa kinesiophobia scale
Time Frame: baseline, 8 weeks: change from baseline kinesiophobia at 8 weeks, 6 months: change from baseline kinesiophobia at 6 months
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.
baseline, 8 weeks: change from baseline kinesiophobia at 8 weeks, 6 months: change from baseline kinesiophobia at 6 months
haemophilia adult health-related quality of life scale
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
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
short form-36
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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Volkan Deniz, PT

Investigators

  • Principal Investigator: Volkan Deniz, Çukurova University

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 Start (Actual)

July 1, 2019

Primary Completion (Actual)

December 13, 2019

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (Actual)

December 19, 2019

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 89/56

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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