NCT04205188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

December 13, 2019

Last Update Submit

July 27, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    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 Outcomes (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

Study Arms (2)

exercises and verbal information

EXPERIMENTAL

therapeutic exercises 3 days in a week and total 8 weeks and 60 minutes verbal information

Other: therapeutic exercises

verbal information

NO INTERVENTION

60 minutes information about effects of exercises on joint functions

Interventions

aerobic- balance -stretching and strengthening exercises

exercises and verbal information

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals older than 18 years
  • diagnosed with hemophilia A or B
  • having at least one joint with hemophilic arthropathy
  • without cognitive problems
  • speaking turkish

You may not qualify if:

  • Individuals with another congenital coagulopathy such as Von Willebrand Syndrome,
  • unable to walk due to hemophilic arthropathy
  • developing inhibition against factor VIII-IX

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Volkan Deniz

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Volkan Deniz

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Clinical Research

Study Record Dates

First Submitted

December 13, 2019

First Posted

December 19, 2019

Study Start

July 1, 2019

Primary Completion

December 13, 2019

Study Completion

January 15, 2020

Last Updated

July 28, 2021

Record last verified: 2021-07

Locations