The Effects of Therapeutic Exercises on Kinesiophobia in Haemophilic Patients.

• Sponsor: Volkan Deniz, PT (Other)
• Overall Status: Completed
• CT.gov ID: NCT04205188
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.5
• Patients Per Site Per Month: 3.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Haemophilia	Other: therapeutic exercises	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Do Therapeutic Exercises Improve Kinesiophobia and Health-Related Quality of Life in Adult Haemophilia Patients? A Randomized Controlled Trial.
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Dec 13, 2019
• Actual Study Completion Date: Jan 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. tampa kinesiophobia scale [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.

2. haemophilia adult health-related quality of life scale [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.

Secondary Outcome Measures

1. short form-36 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Volkan Deniz	Ankara		Turkey	06560

Sponsors and Collaborators

• Volkan Deniz, PT

Investigators

• Principal Investigator: Volkan Deniz, Cukurova University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Volkan Deniz, PT, Director, Clinical Research, Cukurova University
• ClinicalTrials.gov Identifier: NCT04205188
• Other Study ID Numbers: 89/56
• First Posted: Dec 19, 2019
• Last Update Posted: Jul 28, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemophilia A

Study Results

No Results Posted as of Jul 28, 2021