跳至主要内容
临床试验/NCT06588959
NCT06588959尚未招募不适用

"Validity and Reliability of the 6-minute Pegboard Ring Test in Patients with Scleroderma

Yasemin GEDIKLI · Selcuk University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
6-Minute Pegboard and Ring Test

研究概览

简要总结

The aim of this observational study was to evaluate the reliability and validity of the 6-minute pegboard and ring test (6PBRT) in patients with systemic sclerosis. The main question it aims to answer is:

  • Is 6PBRT a valid and reliable method to assess upper extremity functional capacity in patients with systemic sclerosis? Participants will repeat the 6PBRT 2 times 1 hour apart. In addition, respiratory muscle strength (MIP-MEP), upper extremity muscle strength (hand dynanometer and hand-held dynanometer), muscle oxygen saturation (Moxy Monitor Device) will be evaluated.

详细描述

Upper extremity functions are of great importance, especially activities of daily living. There are opinions that the impairment of the upper extremity in scleroderma is greater than that of the lower extremity and affects the functional status of individuals more. This activity limitation is related to many activities of daily living, including unsupported upper limb movements that lead to dyspnea and fatigue in patients with cardiopulmonary disease. Therefore, determining the strength, endurance and exercise capacity of the upper extremities is an important issue in scleroderma management. One of the tests that serves this purpose is the 6PBRT, which has been found to be valid and reliable in patients with chronic obstructive pulmonary disease and asthma.

It was planned as a non-interventional reliability study. The study will investigate the validity and reliability of 6PBRT in patients with scleroderma. In this context, a 1-hour rest break will be given after the first test. Dyspnea and fatigue will be assessed using the Borg scale and muscle oxygenation, heart rate and blood pressure will be recorded before and after 6PBRT. After the 1-hour rest period, the second trial of 6PBRT will be performed. The level of dyspnea and fatigue and initial values of heart rate will be checked before the second trial to ensure that patients are stable. All assessments will be performed by the same physiotherapist. In addition, participants will be assessed for respiratory muscle strength, upper limb muscle strength and muscle oxidation during the performance test.

The smallest sample size of the study was 40 subjects with a correlation coefficient of 0.95 between the two tests and 90% power at 95% confidence interval. 50 subjects are aimed to be recruited against a 20% drop-out risk. Shapiro-Wilk test and histogram plots will be used to check the normality of the data. Demographic and clinical characteristics of the participants will be reported using descriptive statistics. Two-way random effects and absolute agreement methods and intraclass correlation coefficient (ICC) will be used to assess test-retest reliability. Reliability strength will be interpreted as excellent for an ICC value >0.90. The 95% Confidence Interval (95% CI) will be calculated to investigate measurement variability.

研究设计

研究类型
观察性
观察模型
其他
时间视角
横断面

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • Being between the ages of 18-75
  • 2013 To be diagnosed with systemic sclerosis according to ACR/EULAR classification criteria
  • Being clinically stable
  • Ability to adapt to tests (visual, cognitive, cooperative)

排除标准

  • Those with neurological and/or musculoskeletal problems that may affect the work
  • Presence of severe joint contracture or painful ulcers that may affect muscle strength measurement and walking
  • Presence of severe infection or sepsis
  • Being diagnosed with a known additional rheumatologic disease
  • Any stage of cancer
  • Pregnant or breastfeeding

结局指标

主要结局

6-Minute Pegboard and Ring Test

时间窗: baseline

It is used to assess upper extremity exercise capacity.The 6PBRT will be performed using a pegboard with two upper and lower pegs placed at and above the participants\' shoulder level (20 cm). During the test, participants will use both hands simultaneously to move 10 lightweight wooden rings from the lower pegs to the upper pegs. Then, they will move the rings from the top pegs back to the bottom pegs. This activity will continue for six minutes. The aim is to move as many rings as possible during the six minutes. The score will be reported as the number of rings moved simultaneously. Every minute participants will be given standardized verbal encouragement. Heart rate, blood pressure, respiratory frequency, dyspnea and fatigue will be evaluated according to the Modified Borg Scale before and after the test.

次要结局

  • Demographic and Clinical Data(baseline)
  • Extremity Muscle Strength Measurement(baseline)
  • Respiratory muscle strength measurement(baseline)
  • Muscle Oxygen Saturation(baseline)

研究者

发起方
Yasemin GEDIKLISelcuk University
申办方类型
其他
责任方
申办者-研究者
主要研究者

Yasemin GEDIKLI

Faculty of Health Sciences Physiotherapy and Rehabilitation- Research assistant

Selcuk University

研究点 (1)

Loading locations...

标识符

NCT 编号
NCT06588959
其他研究编号
SelcukU-FTR-YG-01

日期

首次提交
(2年前)
首次发布
(2年前)
主要完成日期
(去年)
研究完成日期
(11个月前)
最近核实
最近更新
(2年前)

监管与共享

FDA 监管药物
否
个体参与者数据共享计划
否
是否有结果
否

相似试验