Causes of Kinesiophobia in Lymphedema

November 8, 2021 updated by: Cansu Sahbaz Pirincci, Ankara City Hospital Bilkent

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

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
    • Çankaya
      • Ankara, Çankaya, Turkey, 06800
        • Ankara City Hospital

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Study Group
People who have lymphedema
Other: survey application
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.
Other Names:
  • Lymphedema Group
ACTIVE_COMPARATOR: control group
healty people
Other: survey application
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.
Other Names:
  • Lymphedema Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes
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.
10 minutes
Lymphedema Quality of Life Questionnaire
Time Frame: 10 minutes
It is a survey consisting of 21 questions. High scores indicate lower quality of life.
10 minutes

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

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 (ANTICIPATED)

November 15, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 15, 2021

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

October 26, 2021

First Posted (ACTUAL)

November 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 8, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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