Exercise ToleranceNCT06010459
Reference Values for the Six-minute Pegboard and Ring Test in Healthy Adults in Turkey
An observational study of Exercise Tolerance, run by Ulaş Ar at 1 site in Turkey (Türkiye).
Trial summary
Supported or unsupported arm activities are widely used in all activities of daily living. 6 PBRT is a valid, reliable, useful, practical and easy-to-apply test that evaluates unassisted arm endurance in patients with COPD, asthmatics, and healthy individuals. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Tolerance
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Nov 2021to 1 Nov 2022
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy people aged 20-65 years
Who may be able to join
- To be between the ages of 20-65 years,
- Volunteering to participate in the research
- To be cooperative
- Being between 18.5-40 kg/m2 according to body mass index value
Who cannot join
- Having a neurological disease or other clinical diagnosis that may affect cognitive status,
- Having a musculoskeletal, neurological, cardiopulmonary, neuromuscular or metabolic disease that may affect exercise performance, or having an advanced orthopedic disease (such as kyphoscoliosis),
- Recent shoulder or thoracic surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of 6 Minute Pegboard and Ring Test Exercise Test Reference Values in for the Turkish Healthy Adults
Supported or unsupported arm activities are widely used in all activities of daily living. 6 PBRT is a valid, reliable, useful, practical and easy-to-apply test that evaluates unassisted arm endurance in patients with COPD, asthmatics, and healthy individuals. Studies have recently been conducted showing reference values for 6 PBRT in various populations. 6 Normative values and reference range for PBRT are not available for various ethnicities, including the Turkish population. Therefore, this study aimed to find reference values for 6 PBRT in the Turkish young and middle-aged individuals.
Read the detailed description
Supported or unassisted arm activities are widely used for all activities of daily living. They contribute greatly to performing both simple and complex daily tasks such as brushing, shaving, combing their hair, washing dishes or putting food on shelves; meanwhile, trapezius, pectoralis minor, scalene and intercostal muscles assist arm positioning.
Many studies; It has confirmed that patients with COPD have reduced arm exercise capacity and often experience notable dyspnoea (shortness of breath) and fatigue during arm tasks important to daily living. Two mechanisms have been suggested underlying this: neuromechanical dysfunction of the respiratory muscles (diaphragm and accessory respiratory muscles) (thoracoabdominal asynchrony) and changes in lung volume during activities involving the upper extremities. During arm exercise, accessory respiratory muscles are used for arm function and cannot contribute to respiration. This increases the respiratory load of the mechanically disadvantaged diaphragm and results in thoracoabdominal synchrony and severe dyspnea. Since the muscles that move the arm and stabilize the trunk are attached to the rib cage, they increase the resistance of the chest wall and limit the ability to increase tidal volume during arm activities. These disturbances in ventilatory mechanics result in termination of arm exercise in patients with COPD at lower workloads compared to healthy subjects.
The '6 Minute Pegboard and Ring Test-6PRT' is a valid and reliable, useful, practical and easy-to-apply test that evaluates unassisted arm endurance in COPD patients, asthmatic patients and healthy individuals. For the test, patients are asked to carry as many rings as possible within 6 minutes and the number of rings carried during 6 minutes is recorded as a score.
In a study conducted in patients with mild to very severe COPD, a positive correlation was shown between the 6PRT score and the activity counts evaluated by accelerometer. In addition, it was determined that the 6PRT score showed a clear relationship with the upper extremity ADL, and it was concluded that the 6PRT test could be used as an appropriate test for estimating and demonstrating the improvement of ADL in pulmonary rehabilitation programs.
Studies have recently been published showing reference values for 6PBRT in Brazilian and Indian populations. In one of the results, a correlation was found between the score value and age, showing that younger individuals were able to move more rings than the older group. In addition, a weak correlation was found between the test score and the level of physical activity. Normative values and reference range for 6PBRT are not available for various ethnicities, including the Turkish adults. Therefore, in this study; It is aimed to find reference values for the 6PBRT test in the Turkish adults.
- Conditions
- Exercise Tolerance
- Keywords
- Upper extremity exercise test, six-minute peg board and ring test, exercise tolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
Unsupported Arm Exercise Capacity and Arm Function/Endurance
It will be evaluated with the '6 minute Pegboard and Ring Test-6PRT'. During the test, the patient is asked to sit in front of a pegboard and move as many rings as possible from the two lower holes to the two upper holes, using both hands simultaneously, for 6 minutes. Before the test, participants get used to the test by wearing a few rings. Standardized encouragement is given every minute during the test. The number of rings carried during 6 minutes constitutes the final score. Before and after the test, heart rate and oxygen saturation with pulse oximetry, dyspnea, general fatigue and arm fatigue perception with modified Borg scale are questioned. For the validity of the test, the test will be repeated in the same patient with one week intervals under the same conditions.
Measured: 50 minute
Secondary outcomes (2)
Arm length of both sides and the arm and forearm circumferences of the dominant arm
The measurement was done with non-stretch tape
Measured: 1 day
Physical Activity Level
It was evaluated with the Human Activity Profile.The level of physical activity of individuals is classifi ed by calculating the adjusted activity score (AAS), resulting in their being classifi ed as inactive or debilitated (AAS < 53 points), moderately active (AAS between 53 and 74 points), or active (AAS > 74 points)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start4 Nov 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise ToleranceStudies 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
- Cross-sectional
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulaş Ar
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Sponsor-investigator, Ulaş Ar, Ankara City Hospital Bilkent
- Investigators
- Ebru Calik Kutukcu, Assoc.Prof., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010459
- Sponsor's protocol ID
- PBRT
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of 6 Minute Pegboard and Ring Test Exercise Test Reference Values in for the Turkish Healthy Adults
- ClinicalTrials.gov ID
- NCT06010459
- Acronym / sponsor ID
- PBRT
- Conditions
- Exercise Tolerance
- Keywords
- Upper extremity exercise test, six-minute peg board and ring test, exercise tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Ulaş ArUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 24 Aug 2023 (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.
Supported or unsupported arm activities are widely used in all activities of daily living. 6 PBRT is a valid, reliable, useful, practical and easy-to-apply test that evaluates unassisted arm endurance in patients with COPD, asthmatics, and healthy individuals. Studies have recently been conducted showing reference values for 6 PBRT in various populations. 6 Normative values and reference range for PBRT are not available for various ethnicities, including the Turkish population. Therefore, this study aimed to find reference values for 6 PBRT in the Turkish young and middle-aged individuals.
Detailed description
Supported or unassisted arm activities are widely used for all activities of daily living. They contribute greatly to performing both simple and complex daily tasks such as brushing, shaving, combing their hair, washing dishes or putting food on shelves; meanwhile, trapezius, pectoralis minor, scalene and intercostal muscles assist arm positioning.
Many studies; It has confirmed that patients with COPD have reduced arm exercise capacity and often experience notable dyspnoea (shortness of breath) and fatigue during arm tasks important to daily living. Two mechanisms have been suggested underlying this: neuromechanical dysfunction of the respiratory muscles (diaphragm and accessory respiratory muscles) (thoracoabdominal asynchrony) and changes in lung volume during activities involving the upper extremities. During arm exercise, accessory respiratory muscles are used for arm function and cannot contribute to respiration. This increases the respiratory load of the mechanically disadvantaged diaphragm and results in thoracoabdominal synchrony and severe dyspnea. Since the muscles that move the arm and stabilize the trunk are attached to the rib cage, they increase the resistance of the chest wall and limit the ability to increase tidal volume during arm activities. These disturbances in ventilatory mechanics result in termination of arm exercise in patients with COPD at lower workloads compared to healthy subjects.
The '6 Minute Pegboard and Ring Test-6PRT' is a valid and reliable, useful, practical and easy-to-apply test that evaluates unassisted arm endurance in COPD patients, asthmatic patients and healthy individuals. For the test, patients are asked to carry as many rings as possible within 6 minutes and the number of rings carried during 6 minutes is recorded as a score.
In a study conducted in patients with mild to very severe COPD, a positive correlation was shown between the 6PRT score and the activity counts evaluated by accelerometer. In addition, it was determined that the 6PRT score showed a clear relationship with the upper extremity ADL, and it was concluded that the 6PRT test could be used as an appropriate test for estimating and demonstrating the improvement of ADL in pulmonary rehabilitation programs.
Studies have recently been published showing reference values for 6PBRT in Brazilian and Indian populations. In one of the results, a correlation was found between the score value and age, showing that younger individuals were able to move more rings than the older group. In addition, a weak correlation was found between the test score and the level of physical activity. Normative values and reference range for 6PBRT are not available for various ethnicities, including the Turkish adults. Therefore, in this study; It is aimed to find reference values for the 6PBRT test in the Turkish adults.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy people aged 20-65 years
Key inclusion criteria (4 listed)
- To be between the ages of 20-65 years,
- Volunteering to participate in the research
- To be cooperative
- Being between 18.5-40 kg/m2 according to body mass index value
Key exclusion criteria (3 listed)
- Having a neurological disease or other clinical diagnosis that may affect cognitive status,
- Having a musculoskeletal, neurological, cardiopulmonary, neuromuscular or metabolic disease that may affect exercise performance, or having an advanced orthopedic disease (such as kyphoscoliosis),
- Recent shoulder or thoracic surgery.
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
Unsupported Arm Exercise Capacity and Arm Function/Endurance
Time frame: 50 minute
It will be evaluated with the '6 minute Pegboard and Ring Test-6PRT'. During the test, the patient is asked to sit in front of a pegboard and move as many rings as possible from the two lower holes to the two upper holes, using both hands simultaneously, for 6 minutes. Before the test, participants get used to the test by wearing a few rings. Standardized encouragement is given every minute during the test. The number of rings carried during 6 minutes constitutes the final score. Before and after the test, heart rate and oxygen saturation with pulse oximetry, dyspnea, general fatigue and arm fatigue perception with modified Borg scale are questioned. For the validity of the test, the test will be repeated in the same patient with one week intervals under the same conditions.
2 secondary outcomes
Arm length of both sides and the arm and forearm circumferences of the dominant arm
Time frame: 1 day
Physical Activity Level
Time frame: 1 day
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 24 Aug 2023.
- Individual participant dataSharing planned: No
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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, Assoc.Prof. principal investigator
Hacettepe University
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 Exercise Tolerance, run by Ulaş Ar 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 4 inclusion and 3 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 24 Aug 2023. 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?
Unsupported Arm Exercise Capacity and Arm Function/Endurance (time frame: 50 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2023.