NCT04181905

Brief Summary

Asthma is a heterogeneous disease characterized by chronic airway inflammation characterized by time-varying respiratory symptoms such as wheezing, shortness of breath, chest tightness and cough, with limitation of expiratory airflow. These variations are often triggered by exercise, exposure to allergens or an irritation, weather changes or viral respiratory diseases (Karakış, 2018). Increased respiratory distress decreases the patient's activity, decreases the condition and makes the individual dependent in daily life. In the studies conducted in asthma patients, the cases stated that they perceived their illness as an obstacle against physical activity and thus they were pushed to immobility (Kırtay \& Oğuz, 2011). In the literature, no study on the variable of kinesiophobia in asthma was found. The aim of this study was to investigate the relationship between kinesiophobia and physical activity level and quality of life in asthma patients.

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
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

September 11, 2020

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

November 27, 2019

Last Update Submit

September 10, 2020

Conditions

Keywords

Asthma, Kinesiophobia, Physical Activity, Quality of Life

Outcome Measures

Primary Outcomes (3)

  • Tampa Kinesiophobia Scale (TSK)

    The Tampa Scale of Kinesiophobia (TSK) that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain. The TSK consists of 17 questions.A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement.

    7 days

  • International Physical Activity Questionnaire Short Form (IPAQ-SF)

    The International Physical Activity Questionnaire short-form (IPAQ-SF) is one of the most widely used self-report questionnaires to assess PA. IPAQ-SF is a self-report questionnaire that assesses PA in the last 7 days \[9-10\]. Using the IPAQ-SF scoring system, the total number of days and minutes of PA were calculated for each participant as recommended in the IPAQ website \[32\]. The IPAQ-SF records the activity in four intensity levels: sitting, walking, moderate intensity (e.g., leisure cycling), and vigorous intensity (e.g, running or aerobics). MET method was used to determine the level of physical activity. Standard values for these activities were established. The generated values are expressed as follows; Severe Physical Activity = 8.0 MET, Moderate Severe Physical Activity = 4.0 MET, Walking = 3.3 MET, Sitting = 1.5 MET. Using these values, daily and weekly physical activity levels are calculated.

    7 days

  • Asthma Quality of Life Questionnaire (AQLQ)

    The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma. Participants were asked to score the importance of each of the positively identified problems (0= not important - 4 = very important). The highest scoring problems were the same for both men and women, for patients with a wide range of asthma severity (no medication to oral steroids) and in different age groups.

    14 days

Interventions

Firstly, demographic information (name-surname, date of birth, gender, age, height, body weight, dominant hand, family structure, social security, educational status, occupation, smoking, alcohol use, assistive device drug use, resume, surname, complaints). Data collection tools will then be applied to patients by face to face interview technique. Evaluation of kinesiophobia Assessment of quality of life in asthma patients with TAMPA questionnaire Assessment of physical activity level with Asthma Quality of Life Questionnaire (AQLQ) Assessment of physical activity level with International Physical Activity Questionnaire-Short Form (IPAQ) is planned.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The population of the study was the patients diagnosed with asthma. The sample is planned to be composed of 40 people who meet the criteria of reading, read the information form and signed the informed consent form.

You may qualify if:

  • Being 18-65 years old T
  • Turkish reading, writing, understanding
  • Volunteering to participate in the research

You may not qualify if:

  • Having communication problems, not being cooperative, having a psychiatric diagnosis or using medication
  • Severe comorbid diseases (heart, respiratory, gastrointestinal, neurological diseases) that may cause movement limitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Marmara University

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

Seda Karaca

Istanbul, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

AsthmaKinesiophobiaMotor Activity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPhobic DisordersAnxiety DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Aysel Yildiz Ozer

    Marmara University, Department of Physiotherapy and Rehabilitation

    STUDY CHAIR
  • Seda Karaca

    Marmara University, Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 2, 2019

Study Start

April 21, 2019

Primary Completion

December 18, 2020

Study Completion

February 1, 2021

Last Updated

September 11, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations