NCT05105594

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

16 days

First QC Date

October 26, 2021

Last Update Submit

November 8, 2021

Conditions

Keywords

lymphedema, Kinesiophobia

Outcome Measures

Primary Outcomes (3)

  • Kinesiophopia Causes Scale

    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

    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

    It is a survey consisting of 21 questions. High scores indicate lower quality of life.

    10 minutes

Study Arms (2)

Study Group

ACTIVE COMPARATOR

People who have lymphedema

Other: survey application

control group

ACTIVE COMPARATOR

healty people

Other: survey application

Interventions

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.

Also known as: Lymphedema Group
Study Groupcontrol group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

LymphedemaKinesiophobia

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesPhobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 3, 2021

Study Start

November 15, 2021

Primary Completion

December 1, 2021

Study Completion

December 15, 2021

Last Updated

November 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations