LymphedemaNCT05105594
Causes of Kinesiophobia in Lymphedema
A study testing survey application in people with Lymphedema, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In this study, the reason for the fear of movement in patients with lymphedema will be investigated and recommendations will be given to the patients to eliminate it. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphedema
- What is being tested?
- survey application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 15 Dec 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those between the ages of 18-65
- To be diagnosed with lymphedema in the unilateral lower extremity
- Volunteering to work
- Not having orthopedic disorders in the lower extremities
Who cannot join
- Not volunteering to participate in the research
- Having bilateral lower extremity lymphedema
- Having an active infection
- Having a mental cognitive disorder
- Being unable to communicate and cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Causes of Kinesiophobia, Fatigue and Quality of Life in Patients With Lower Extremity Lymphedema
In this study, the reason for the fear of movement in patients with lymphedema will be investigated and recommendations will be given to the patients to eliminate it.
- Conditions
- Lymphedema
- Being tested
- survey application
- Keywords
- lymphedema, Kinesiophobia
- Medical subject headings
- Lymphedema, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey applicationOther
Also called Lymphedema Group
Fear of movement will be evaluated with the Kinesiophopia Causes Scale. It is a 20-question survey in which the causes of fear of movement are investigated. Functional Evaluation of Treatment of Fatigue Chronic Disease will be assessed by the Fatigue Questionnaire. It consists of 13 questions assessing the level of fatigue during daily activities in the last 7 days. Quality of Life will be assessed by the Lymphedema Quality of Life Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Active comparator | People who have lymphedema Receives: Other: survey application |
| control group | Active comparator | healty people Receives: Other: survey application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinesiophopia Causes Scale
It is a 20 question survey. A higher score on the questionnaire indicates that they have more fear of movement.
Measured: 10 minutes
functional assessment of chronic illness therapy
It consists of 13 questions assessing the level of fatigue during daily activities in the last 7 days.
Measured: 10 minutes
Lymphedema Quality of Life Questionnaire
It is a survey consisting of 21 questions. High scores indicate lower quality of life.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start15 Nov 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Sahbaz Pirincci, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105594
- Sponsor's protocol ID
- CSP1
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Causes of Kinesiophobia, Fatigue and Quality of Life in Patients With Lower Extremity Lymphedema
- ClinicalTrials.gov ID
- NCT05105594
- Acronym / sponsor ID
- CSP1
- Conditions
- Lymphedema
- Keywords
- lymphedema, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Nov 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 3 Nov 2021 (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.
In this study, the reason for the fear of movement in patients with lymphedema will be investigated and recommendations will be given to the patients to eliminate it.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Active comparator | Other: survey applicationPeople who have lymphedema |
| control group | Active comparator | Other: survey applicationhealty people |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Those between the ages of 18-65
- To be diagnosed with lymphedema in the unilateral lower extremity
- Volunteering to work
- Not having orthopedic disorders in the lower extremities
Key exclusion criteria (5 listed)
- Not volunteering to participate in the research
- Having bilateral lower extremity lymphedema
- Having an active infection
- Having a mental cognitive disorder
- Being unable to communicate and cooperate
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 |
|---|---|---|
| survey applicationAlso: Lymphedema GroupFear of movement will be evaluated with the Kinesiophopia Causes Scale. It is a 20-question survey in which the causes of fear of movement are investigated. Functional Evaluation of Treatment of Fatigue Chronic Disease will be assessed by the Fatigue Questionnaire. It consists of 13 questions assessing the level of fatigue during daily activities in the last 7 days. Quality of Life will be assessed by the Lymphedema Quality of Life Questionnaire. | Other | Study Group, control group |
Primary outcome
Kinesiophopia Causes Scale
Time frame: 10 minutes
It is a 20 question survey. A higher score on the questionnaire indicates that they have more fear of movement.
functional assessment of chronic illness therapy
Time frame: 10 minutes
It consists of 13 questions assessing the level of fatigue during daily activities in the last 7 days.
Lymphedema Quality of Life Questionnaire
Time frame: 10 minutes
It is a survey consisting of 21 questions. High scores indicate lower quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing survey application in people with Lymphedema, run by Ankara City Hospital Bilkent 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 5 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: status not confirmed, as of the sponsor's last update on 9 Nov 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?
Results are not available in the source record.
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?
Kinesiophopia Causes Scale (time frame: 10 minutes). The study lists 3 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 9 Nov 2021.