HaemophiliaNCT04205188
The Effects of Therapeutic Exercises on Kinesiophobia in Haemophilic Patients.
A study testing therapeutic exercises in people with Haemophilia, run by Volkan Deniz, PT at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Haemophilia
- What is being tested?
- therapeutic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 15 Jan 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals older than 18 years
- diagnosed with hemophilia A or B
- having at least one joint with hemophilic arthropathy
- without cognitive problems
- speaking turkish
Who cannot join
- Individuals with another congenital coagulopathy such as Von Willebrand Syndrome,
- unable to walk due to hemophilic arthropathy
- developing inhibition against factor VIII-IX
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Therapeutic Exercises Improve Kinesiophobia and Health-Related Quality of Life in Adult Haemophilia Patients? A Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Haemophilia
- Being tested
- therapeutic exercises
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic exercisesOther
aerobic- balance -stretching and strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| exercises and verbal information | Experimental | therapeutic exercises 3 days in a week and total 8 weeks and 60 minutes verbal information Receives: Other: therapeutic exercises |
| verbal information | No intervention | 60 minutes information about effects of exercises on joint functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Jul 2019
- Primary completion13 Dec 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemophiliaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volkan Deniz, PT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Volkan Deniz, PT, Cukurova University
- Investigators
- Volkan Deniz, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205188
- Sponsor's protocol ID
- 89/56
- Status last verified
- Jul 2021
- First submitted
- 13 Dec 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Therapeutic Exercises Improve Kinesiophobia and Health-Related Quality of Life in Adult Haemophilia Patients? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04205188
- Acronym / sponsor ID
- 89/56
- Conditions
- Haemophilia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Volkan Deniz, PTUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 19 Dec 2019 (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.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercises and verbal information | Experimental | Other: therapeutic exercisestherapeutic exercises 3 days in a week and total 8 weeks and 60 minutes verbal information |
| verbal information | No intervention | –60 minutes information about effects of exercises on joint functions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals older than 18 years
- diagnosed with hemophilia A or B
- having at least one joint with hemophilic arthropathy
- without cognitive problems
- speaking turkish
Key exclusion criteria (3 listed)
- Individuals with another congenital coagulopathy such as Von Willebrand Syndrome,
- unable to walk due to hemophilic arthropathy
- developing inhibition 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 exercisesaerobic- balance -stretching and strengthening exercises | Other | exercises and verbal information |
Primary outcome
tampa kinesiophobia scale
Time frame: 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.
haemophilia adult health-related quality of life scale
Time frame: 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.
1 secondary outcome
short form-36
Time frame: 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
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 28 Jul 2021.
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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.
Volkan Deniz principal investigator
Cukurova 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 Haemophilia, run by Volkan Deniz, PT 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 5 inclusion and 3 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 28 Jul 2021. 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?
tampa kinesiophobia scale (time frame: baseline, 8 weeks: change from baseline kinesiophobia at 8 weeks, 6 months: change from baseline kinesiophobia 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 28 Jul 2021.