NCT04051060

Brief Summary

The aim of this study was to evaluate exercise capacity and activity role adequacy in patients with adult bronchial asthma.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

April 21, 2019

Last Update Submit

August 8, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Evaluation of Exercise Capacity

    Exercise capacity will be evaluated with a six-minute walk test (6MWT). The patients will be asked to walk as fast as they can in their own walking tempo for six minutes in a 28-meter straight corridor.6DYT distance value has normal values according to age and sex. These values will be taken as reference in the interpretation of the measurements.

    Day 1

  • Evaluation of Activity-Role Adequacy

    Activity-role adequacy in asthma patients will be assessed using the "Activity Self-Assessment" questionnaire. The Activity Self-Assessment questionnaire is a person-centered assessment tool designed to determine how illness and disability affect individuals' activities and roles. The Activity Self-Assessment Questionnaire is a person-centered assessment questionnaire consisting of 21 items and importance related to activity-role competence. The Activity Self-Assessment questionnaire asks the individual to score each item and value on two separate 4-point scales for activity adequacy. The points obtained are summed up to obtain two separate total points, namely competence and importance. These scores are converted to scores between 0-100 with the method in the application guide of the scale. As the total score increases, activity self-efficacy and importance increases.

    Day 1

Secondary Outcomes (7)

  • Assessment of Respiratory Functions

    Day 1

  • Evaluation of Functional Capacity

    Day 1

  • Evaluation of Daily Living Activities

    Day 1

  • Evaluation of Quality of Life

    Day 1

  • Assessment of Quality of Life in Asthmatic Patients

    Day 1

  • +2 more secondary outcomes

Study Arms (2)

Patients with Bronchial Asthma

Healthy individuals

Eligibility Criteria

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

Individuals who will participate in the study will have stable bronchial asthma who is diagnosed in Kocaeli University Faculty of Medicine, Department of Chest Diseases or has a clinical condition that comes to routine control of Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.

You may qualify if:

  • Be diagnosed with bronchial asthma by a chest physician
  • Being between the ages of 18-65
  • Being in a stable period
  • Work in the last 12 months

You may not qualify if:

  • Severe chronic disease other than bronchial asthma (cancer, chronic obstructive pulmonary disease, chronic heart failure, neurological disease, etc.).
  • Any physical disability that prevents walking
  • Unable to comply with tests
  • lack of reading, speaking and writing in Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melda Sağlam

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AsthmaKinesiophobia

Condition Hierarchy (Ancestors)

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

Study Officials

  • MELDA SAĞLAM, PhD

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

April 21, 2019

First Posted

August 9, 2019

Study Start

February 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

August 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Locations