NCT06010459

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

November 4, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

August 18, 2023

Last Update Submit

August 23, 2023

Conditions

Keywords

Upper extremity exercise testsix-minute peg board and ring testexercise tolerance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Arm length of both sides and the arm and forearm circumferences of the dominant arm

    1 day

  • Physical Activity Level

    1 day

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy people aged 20-65 years

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe Üniversitesi

Ankara, 06000, Turkey (Türkiye)

Location

Study Officials

  • Ebru Calik Kutukcu, Assoc.Prof.

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

August 18, 2023

First Posted

August 24, 2023

Study Start

November 4, 2021

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

August 24, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations