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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06010459
Other study ID # PBRT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 4, 2021
Est. completion date November 1, 2022

Study information

Verified date August 2023
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 132
Est. completion date November 1, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Hacettepe Üniversitesi Ankara

Sponsors (2)

Lead Sponsor Collaborator
Ulas Ar Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 50 minute
Secondary Arm length of both sides and the arm and forearm circumferences of the dominant arm The measurement was done with non-stretch tape 1 day
Secondary 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) 1 day
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