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6-Minute Pegboard and Ring Test Unsupported Arm Function Exercise Test in Asthma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693664
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Ebru Calik Kutukcu, Hacettepe University

Brief Summary:
Exercise intolerance is one of the most problems in chronic obstructive pulmonary disease (COPD) and occurs not only in performing lower body tasks but also in performing arm activities. During arm exercise, auxiliary respiratory muscles are used for arm duty and cannot contribute to breathing. This increases the respiratory load of the diaphragm, which is mechanically disadvantageous, and results in thoracoabdominal synchronization disorder and severe dyspnea. Although the relationship between activity limitation and quality of life is clear in patients with exertional activity, the literature on physical activity is insufficient. Exercise and physical activity can also and exercise-related respiratory symptoms are known to have adverse effects on daily living activities (ADLs). There is no gold standard for objective assessment of activity limitation and exertional dyspnea in patients with asthma. Therefore, the results obtained by evaluating the validity and reliability of the 6PRT test in asthmatic patients in this study will increase the use of this test to test both arm endurance and arm exercise capacity in adult asthmatic patients, to estimate the effect on ADLs and to demonstrate the development obtained with pulmonary rehabilitation. .

Condition or disease
Asthma

Detailed Description:

Objective: The aim of the study was to evaluate the validity and reliability of the six-minute pegboard and ring test in patients with controlled and partially controlled asthma.

  • Demographic information: Name, age, diagnosis, occupation, body weight, height, The symptoms of the dominant and affected side, CV, family history, obstructive pulmonary diseases (dyspnoea, cough, incontinence frequency), clinical findings and respiratory function test parameters will be recorded.
  • Assessment of Respiratory Muscle Strength: With intraoral pressure measurement instrument will be measured.
  • Evaluation of Hand Grip Force: It will be measured by hand dynamometer.
  • Unarmed Arm Exercise Capacity and Arm Function / Endurance Evaluation: '6 minute Pegboard and Ring Test-6PRT'. During the test, the patient is asked to sit in front of a perforated panel and to carry as many rings as possible for six minutes to the two upper holes using two hands at the same time. Participants are attached to the test by installing a few rings before the test. Standardized encouragement is given every minute during the test. The number of rings carried for 6 minutes constitutes the final score. Before and after the test, pulse oximetry and heart rate and oxygen saturation, modified Borg scale, dyspnea, general fatigue and arm fatigue are questioned. For the validity of the test, the test will be repeated in the same patient under the same conditions every one week.

    -Evaluation of Maximal Arm Exercise Capacity: With arm ergometer limited exercise test with maximal symptoms will be evaluated and used as a criterion for the reliability of 6PRT test.

  • Daily life activities of dyspnea and breathlessness Evaluation of its Effect: The Modified Medical Research Council Scale will be evaluated with an objective measurement of 3 minutes breathing exercise test and London Chest Daily Living Activities Scale.
  • Evaluation of Postural Awareness: The validity of the Turkish version developed by Shields, Mallory & Simon in 1989 will be evaluated by the Body Awareness Survey (VFA).
  • Evaluation of Daily Living Activities: London Chest GYA Scale (25) and Milliken GYA Scale will be evaluated.
  • Assessment of Quality of Life: Disease-specific Asthma Quality of Life Scale and Health Assessment Questionnaire.
  • Asthma Control Assessment: Asthma Control Test will be evaluated.

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Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Validity and Reliability of the 6-Minute Pegboard and Ring Test Unsupported Arm Function Exercise Test in Controlled and Partially Controlled Asthma Patients
Actual Study Start Date : March 3, 2019
Actual Primary Completion Date : February 3, 2020
Actual Study Completion Date : February 3, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 6 minute Pegboard and Ring Test-6PRT [ Time Frame: one year ]
    Total number of rings installed within six minutes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Validity and reliability
Criteria

Inclusion Criteria:

  • To have a controlled or partially controlled asthma diagnosis, Have not experienced acute exacerbation in the last 3 months, Being between 18-80 years of age, Volunteer for research, To be able to walk and cooperate.

Exclusion Criteria:

  • To have a neurological disease or another clinical diagnosis that may affect cognitive status,
  • To have musculoskeletal and neurological disease, symptomatic heart disease, previous lung surgery and malignant disease that may affect exercise performance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693664


Locations
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Turkey
Hacettepe University
Ankara, State, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
Investigators
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Principal Investigator: Ebru Calik Kutukcu, Phd Hacettepe University Physiotherapy and Rehabilitation
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Responsible Party: Ebru Calik Kutukcu, principal investigator, Hacettepe University
ClinicalTrials.gov Identifier: NCT03693664    
Other Study ID Numbers: GO 18206/24
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ebru Calik Kutukcu, Hacettepe University:
Asthma
Daily Living Activities
6 Minute Pegboard and Ring Test
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases