Hemophilic ArthropathyNCT04297696
The Effects of Exercises on Gait in Hemophilic Individuals
A study testing Therapeutic exercises in people with Hemophilic Arthropathy, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hemophilic Arthropathy
- What is being tested?
- Therapeutic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 2 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemophilic Arthropathy
- Being tested
- Therapeutic exercises
- Keywords
- hemophilia, exercise, gait kinematic
- Medical subject headings
- Hemophilia A, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercisesOther
A program including warm-up period and neuromuscular exercises is applied progressively in two phases.
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | therapeutic exercises Receives: Other: Therapeutic exercises |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemophilia Joint Health Score
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.
Measured: Baseline, Change from baseline HJHS at 2 months, Change from baseline HJHS at 6 months
Range of Motion Analysis with Kinovea Software
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.
Measured: Baseline, Change from baseline range of motion during gait at 2 months, Change from baseline range of motion during gait at 6 months.
Secondary outcomes (2)
Haemophilia Quality of Life Questionnaire for Adults
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
Measured: Baseline, Change from baseline 6min-WT at 2 months, Change from baseline Quality of life at 6 months
Six Minutes Walking Test
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.
Measured: Baseline, Change from baseline 6min-WT at 2 months, Change from baseline 6min-WT at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Jan 2020
- Primary completion1 Jun 2020
- Study completion2 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilic ArthropathyStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Deniz, PT, Cukurova University
- Investigators
- Nevin Atalay Güzel, Prof Dr, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297696
- Sponsor's protocol ID
- 89/55
- Status last verified
- Nov 2020
- First submitted
- 29 Feb 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effectiveness of Therapeutic Exercises on Target Joint Functions and Gait in Hemophilic Arthropathic Patients.
- ClinicalTrials.gov ID
- NCT04297696
- Acronym / sponsor ID
- 89/55
- Conditions
- Hemophilic Arthropathy
- Keywords
- hemophilia, exercise, gait kinematic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Other: Therapeutic exercisestherapeutic exercises |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic exercisesA program including warm-up period and neuromuscular exercises is applied progressively in two phases. | Other | exercise group |
Primary outcome
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.
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.
2 secondary outcomes
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
Six Minutes Walking Test
Time frame: Baseline, Change from baseline 6min-WT at 2 months, Change from baseline 6min-WT at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
Related trials for Hemophilic Arthropathy
Enrolling by invitation
3D Ultrasound in Hemophilic Ankles
Hemophilia
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Identification of New Biomarkers in Haemophilic Arthropathy Through Transcriptome Analysis
Hemophilia A and B
Not yet recruiting
Multicomponent Pain Self-Management in Adults With Haemophilic Arthropathy
Hemophilic Arthropathy, Chronic Pain
Active, not recruitingPhase 2/3
Real-World Joint Outcomes After Selective Transition to Low-Dose Emicizumab in Pediatric Hemophilia A
Hemophilia A Patient
Not yet recruiting
Effectiveness of an Educational Program for Pain Management in Patients With Hemophilic Arthropathy
Hemophilia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nevin Atalay Güzel, Prof Dr study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic exercises in people with Hemophilic Arthropathy, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemophilia Joint Health Score (time frame: Baseline, Change from baseline HJHS at 2 months, Change from baseline HJHS at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.