The Effects of Exercises on Gait in Hemophilic Individuals

Sponsor
Cukurova University (Other)
Overall Status
Completed
CT.gov ID
NCT04297696
Collaborator
(none)
19
1
2
5
3.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Therapeutic exercises
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation of Effectiveness of Therapeutic Exercises on Target Joint Functions and Gait in Hemophilic Arthropathic Patients.
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Jun 2, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: exercise group

therapeutic exercises

Other: Therapeutic exercises
A program including warm-up period and neuromuscular exercises is applied progressively in two phases.

No Intervention: control group

Outcome Measures

Primary Outcome Measures

  1. Haemophilia Joint Health Score [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.

  2. Range of Motion Analysis with Kinovea Software [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.

Secondary Outcome Measures

  1. Haemophilia Quality of Life Questionnaire for Adults [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

  2. Six Minutes Walking Test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cukurova University Gym Adana Turkey 01100

Sponsors and Collaborators

  • Cukurova University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Volkan Deniz, PT, Director, Cukurova University
ClinicalTrials.gov Identifier:
NCT04297696
Other Study ID Numbers:
  • 89/55
First Posted:
Mar 5, 2020
Last Update Posted:
Nov 13, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Volkan Deniz, PT, Director, Cukurova University

Study Results

No Results Posted as of Nov 13, 2020