The Effects of Exercises on Gait in Hemophilic Individuals

November 11, 2020 updated by: Volkan Deniz, PT, Cukurova University

Investigation of Effectiveness of Therapeutic Exercises on Target Joint Functions and Gait in Hemophilic Arthropathic Patients.

Arthropathy characterized by synovitis, cartilage degeneration, subchondral and interosseous cysts occur due to hemorrhage in hemophilia. This situation causes to chronic pain, decreasing in range of motion, muscle strength, proprioception. Disorders in these parameters are the main causes of gait dysfunction. The aim of this study is to investigate the effects of therapeutic exercises on target joint functions and gait kinematics, and to determine possible complications related to exercise in hemophilic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

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
      • Adana, Turkey, 01100
        • Cukurova University Gym

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • To be diagnosed as Hemophilia A or Hemophilia B
  • To be over 18 years old
  • To have hemophilic arthropathy in at least one joint
  • Undergoing prophylaxis or factor VIII-IX replacement therapy

Exclusion Criteria:

  • Having another congenital coagulopathy, such as Von Willebrand syndrome
  • To be unable to walk due to hemophilic arthropathy
  • Having another musculoskeletal problem
  • Individuals with inhibitors 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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control group
EXPERIMENTAL: exercise group
therapeutic exercises
Other: Therapeutic exercises
A program including warm-up period and neuromuscular exercises is applied progressively in two phases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemophilia Joint Health Score
Time Frame: Baseline, Change from baseline HJHS at 2 months, Change from baseline HJHS at 6 months
Haemophilia Joint Health Score (HJHS) will be applied to evaluate the joint functions of hemophilic individuals. HJHS is a sensitive and valid test used to determine the severity of clinical symptoms that result from hemarthrosis. This comprises an assessment of joints with regards to swelling, muscle atrophy, crepitus, range of motion, joint pain, strength, and global gait. The score for each joint is summed to obtain a total score ranging from 0 to 124, where no joint damage is indicated by a score of 0.
Baseline, Change from baseline HJHS at 2 months, Change from baseline HJHS at 6 months
Range of Motion Analysis with Kinovea Software
Time Frame: Baseline, Change from baseline range of motion during gait at 2 months, Change from baseline range of motion during gait at 6 months.
Range of motion (ROM) analysis during gait will be done by analyzing video images with computer software "Kinovea". Kinovea is a free software used by sports and healthcare professionals to analyze video images during physical activity. Furthermore, it is a sensitive method that can be used to evaluate the range of motion of the lower limb joints during gait. ROM analysis of the ankle and knee joints will be done with Kinovea in the heel strike-midstance-toe off and mid-swing phases.
Baseline, Change from baseline range of motion during gait at 2 months, Change from baseline range of motion during gait at 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemophilia Quality of Life Questionnaire for Adults
Time Frame: Baseline, Change from baseline 6min-WT at 2 months, Change from baseline Quality of life at 6 months
The Haem-A-QoL questionnaire including 10 sections and 46 questions was used to evaluate the changes in the Quality of life of PwH; low scores indicate high QoL
Baseline, Change from baseline 6min-WT at 2 months, Change from baseline Quality of life at 6 months
Six Minutes Walking Test
Time Frame: Baseline, Change from baseline 6min-WT at 2 months, Change from baseline 6min-WT at 6 months
Six-Minutes Walking Test (6min-WT) will be applied to determine the effects of therapeutic exercises on the aerobic capacity of hemophilic individuals. This test is a valid and reliable method for determining aerobic capacity in patients with neuromuscular problems. High walking distance indicates high aerobic capacity.
Baseline, Change from baseline 6min-WT at 2 months, Change from baseline 6min-WT at 6 months

Collaborators and Investigators

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

Sponsor

Cukurova University

Investigators

  • Study Director: Nevin Atalay Güzel, Prof Dr, Gazi 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)

January 1, 2020

Primary Completion (ACTUAL)

June 1, 2020

Study Completion (ACTUAL)

June 2, 2020

Study Registration Dates

First Submitted

February 29, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (ACTUAL)

March 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 89/55

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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