AsthmaNCT03693664
6-Minute Pegboard and Ring Test Unsupported Arm Function Exercise Test in Asthma Patients
An observational study of Asthma, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2019to 3 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Validity and reliability
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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. .
Read the 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.
- Conditions
- Asthma
- Keywords
- Asthma, Daily Living Activities, 6 Minute Pegboard and Ring Test
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute Pegboard and Ring Test-6PRT
Total number of rings installed within six minutes
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start3 Mar 2019
- Primary completion3 Feb 2020
- Study completion3 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Ebru Calik Kutukcu, Phd, Principal investigator, Hacettepe University Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693664
- Sponsor's protocol ID
- GO 18206/24
- Status last verified
- May 2020
- First submitted
- 1 Oct 2018
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Calik-Kutukcu E, Tekerlek H, Bozdemir-Ozel C, Karaduz BN, Cakmak A, Inal-Ince D, Saglam M, Vardar-Yagli N, Sonbahar-Ulu H, Firat M, Arikan H, Kaya SB, Karakaya G. Validity and reliability of 6-minute pegboard and ring test in patients with asthma. J Asthma. 2022 Jul;59(7):1387-1395. doi: 10.1080/02770903.2021.1930040. Epub 2021 May 31.
PubMed 33985406
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03693664
- Acronym / sponsor ID
- GO 18206/24
- Conditions
- Asthma
- Keywords
- Asthma, Daily Living Activities, 6 Minute Pegboard and Ring Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Validity and reliability
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6 minute Pegboard and Ring Test-6PRT
Time frame: one year
Total number of rings installed within six minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Derived from this study: PubMed 33985406Calik-Kutukcu E, Tekerlek H, Bozdemir-Ozel C, Karaduz BN, Cakmak A, Inal-Ince D, Saglam M, Vardar-Yagli N, Sonbahar-Ulu H, Firat M, Arikan H, Kaya SB, Karakaya G. Validity and reliability of 6-minute pegboard and ring test in patients with asthma. J Asthma. 2022 Jul;59(7):1387-1395. doi: 10.1080/02770903.2021.1930040. Epub 2021 May 31.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Calik Kutukcu, Phd principal investigator
Hacettepe University Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute Pegboard and Ring Test-6PRT (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03693664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.