NCT03509311

Brief Summary

The primary aim of the study is to evaluate the physical activity level in patients with asthma. The secondary aims of the study are assesment of maximal and functional exercise capacity, respiratory functions, respiratory muscle strength and endurance, peripheral muscle strength, depression and anxiety levels, disease specific and respiratory quality of life, sleep and coughing associated quality of life, asthma self-management knowledge level and fatigue severity in patients with asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 17, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

April 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

10 months

First QC Date

April 17, 2018

Last Update Submit

May 29, 2021

Conditions

Keywords

AsthmaPhysical activityCardiorespiratory fitnessQuality of life

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Level

    Multi sensor activity monitor

    First Day

Secondary Outcomes (14)

  • Pulmonary Functions

    First Day

  • Respiratory Muscle Strength

    First Day

  • Respiratory Muscle Endurance

    First day

  • Peripheral Muscle Strength

    First Day

  • Disease Spesific Quality of Life

    First Day

  • +9 more secondary outcomes

Study Arms (2)

Asthma Group

That group consists from patients who had diagnosed as asthma by doctors from Chest Diseases Department of Gazi University Hospital. Physical activity level assesment, maximal and submaximal exercise capacity assesment, respiratory function assesment, respiratory muscle strength assesment, respiratory muscle endurance assesment, peripheral muscle strength assesment, quality of life assesment about disease specific, respiratory, sleep and cough associated, fatigue severity assesment, depression and anxiety level assesment and asthma management knowledge assesment apply to this group.

Healthy Group

That group consists from participants who do not have any diagnosed disease. Physical activity level assesment, maximal and submaximal exercise capacity assesment, respiratory function assesment, respiratory muscle strength assesment, respiratory muscle endurance assesment, peripheral muscle strength assesment, quality of life assesment about disease specific, respiratory, sleep and cough associated, fatigue severity assesment and depression and anxiety level assesment apply to this group.

Eligibility Criteria

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

For Asthma Group: Thirty six patients with asthma will be included in this group For Healthy Group: Thirty six healthy volunteer will be included in this group.

You may qualify if:

  • Between 18-65 years
  • Diagnosed with asthma
  • Receiving standard medical treatment
  • Asthma Control Test score ≥ 20 point
  • No smoker or ex-smoker (if ex-smoker, smoke exposure below 10 packyears)
  • Willing to participate in the study

You may not qualify if:

  • Have cooperation difficulty
  • Have pulmonary disease (except asthma for asthma group)
  • Have any cardiac, neurological or orthopedic disease that affects functional capacity
  • Have pneumonia or acute infection (at last one month)
  • Have been used oral corticosteroids at last one year
  • Have any psychiatric diseases
  • Refusing to participate
  • Received or are receiving non-standard medical treatment will be excluded from study.
  • Between 18-65 years without any diagnosed disease
  • No smoker or ex-smoker (if ex-smoker, smoke exposure below 10 packyears)
  • Willing to participate in the study will be included in healthy group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Clinic

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (7)

  • Bruno A, Uasuf CG, Insalaco G, Barazzoni R, Ballacchino A, Gjomarkaj M, Pace E. Nutritional status and physical inactivity in moderated asthmatics: A pilot study. Medicine (Baltimore). 2016 Aug;95(31):e4485. doi: 10.1097/MD.0000000000004485.

    PMID: 27495092BACKGROUND
  • Shei RJ, Paris HL, Wilhite DP, Chapman RF, Mickleborough TD. The role of inspiratory muscle training in the management of asthma and exercise-induced bronchoconstriction. Phys Sportsmed. 2016 Nov;44(4):327-334. doi: 10.1080/00913847.2016.1176546. Epub 2016 Apr 26.

    PMID: 27094568BACKGROUND
  • Ramos E, de Oliveira LV, Silva AB, Costa IP, Correa JC, Costa D, Alves VL, Donner CF, Stirbulov R, Arena R, Sampaio LM. Peripheral muscle strength and functional capacity in patients with moderate to severe asthma. Multidiscip Respir Med. 2015 Jan 21;10(1):3. doi: 10.1186/2049-6958-10-3. eCollection 2015.

    PMID: 25973197BACKGROUND
  • Vargas Becerra MH. [Physiopathology of asthma]. Rev Alerg Mex. 2009;56 Suppl 1:S24-8. Spanish.

    PMID: 20873050BACKGROUND
  • Fitting JW. [Fatigue of the respiratory muscles]. Schweiz Med Wochenschr. 1992 Feb 29;122(9):302-6. French.

    PMID: 1546280BACKGROUND
  • Cluley S, Cochrane GM. Psychological disorder in asthma is associated with poor control and poor adherence to inhaled steroids. Respir Med. 2001 Jan;95(1):37-9. doi: 10.1053/rmed.2000.0968.

    PMID: 11207015BACKGROUND
  • Stucky BD, Sherbourne CD, Edelen MO, Eberhart NK. Understanding asthma-specific quality of life: moving beyond asthma symptoms and severity. Eur Respir J. 2015 Sep;46(3):680-7. doi: 10.1183/09031936.00225014. Epub 2015 Apr 16.

    PMID: 25882804BACKGROUND

MeSH Terms

Conditions

AsthmaMotor Activity

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBehavior

Study Officials

  • Furkan Ozdemir, PT

    Gazi University

    STUDY CHAIR
  • Meral Bosnak Guclu, Assoc. Prof

    Gazi University

    STUDY DIRECTOR
  • Hanim Eda Goktas, PhD

    Gazi University

    PRINCIPAL INVESTIGATOR
  • I. Kivilcim Oguzulgen, MD

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 26, 2018

Study Start

April 20, 2018

Primary Completion

January 30, 2019

Study Completion

July 30, 2019

Last Updated

June 2, 2021

Record last verified: 2021-05

Locations