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Active, Not Recruiting

NCT Number: NCT07122141

Validity and Reliability of the 6-Minute Pegboard and Ring Test in Interstitial Lung Disease

The aim of this study is to investigate the validity and reliability of the 6 Minutes Pegboard and Ring Test (6PBRT) in patients with Interstitial Lung Disease (ILD).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

Our study was conducted in the Chest Diseases Clinic of Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital. Our study was approved by the Marmara University Faculty of Health Sciences Non-Interventional Clinical Research Ethics Committee and was conducted in accordance with the Declaration of Helsinki. Signed informed consent was obtained from the participants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • who were diagnosed with ILD according to the ATS/ERS/JRS/ALAT guidelines,
  • were over 18 years of age,
  • had not changed their treatment for the last 3 months,
  • had a stable clinical status for the last 3 months.

Exclusion criteria

  • Neurological comorbidity,
  • Orthopedic comorbidity that impairs upper extremity function,
  • Kyphoscoliosis and/or severe postural abnormalities,
  • Uncontrolled cardiac problems,
  • Uncontrolled diagnosis of Diabetes Mellitus,
  • Ischemic heart disease,
  • Newly diagnosed history of cancer,
  • Diagnosis of obstructive pulmonary disease,
  • Cognitive impairments such as Alzheimer's or dementia,
  • Use of immunosuppressive medications (excluding corticosteroids),
  • History of recent surgery,
  • Refusal to answer questions,
  • Refusal to participate voluntarily.

Treatment and study plan

Primary outcomes

  1. 6 Minutes Pegboard and Ring Test (6PBRT)

    Time frame: Day 1

    The 6-Minute Pegboard and Ring Test (6PBRT) is designed to assess upper extremity functional capacity using unsupported arm movements. The setup includes four horizontally aligned bars: two at shoulder height and two positioned 20 cm above. Participants, seated with back support, sequentially transfer rings between the bars for six minutes, and the total number of rings moved serves as the performance score.

  2. 6 Minutes Walking Tests (6MWT)

    Time frame: Day 1

    Total distance walked (in meters) during the 6MWT will be recorded. Higher distance reflects improved functional capacity.

  3. Unsupported Upper-Limb Exercise Test (UULEX)

    Time frame: Day 1

    Patients will be instructed to lift five bars consecutively and rhythmically until the onset of fatigue. The bars will have incremental weights of 200 g, 500 g, 1 kg, and 2 kg, respectively. The duration of the activity will be recorded to assess the patients' endurance levels.

Secondary outcomes

  1. 1 Minute Sit to Stand Test (1MSTST)

    Time frame: Day 1

    The 1-Minute Sit-to-Stand Test (1MSTST) is a simple, inexpensive, and practical assessment used to evaluate functional capacity in a small space. During the test, participants are asked to repeatedly sit down and stand up from a fixed chair as quickly as possible for one minute, without using their arms for support.

  2. Spirometric measurements (Forced vital capacity - FVC)

    Time frame: Day 1

    It is used to assess respiratory function and is measured using a spirometer. Forced Vital Capacity (FVC) refers to the maximum volume of air that can be forcefully exhaled from the lungs after a full inhalation. This value can be expressed in liters or as a percentage.

  3. Spirometric measurements (First second forced expiratory volume - FEV1)

    Time frame: Day 1

    It is employed to assess respiratory functions and is measured using a spirometer. Forced Expiratory Volume in the first second (FEV₁) represents the volume of air that can be forcefully exhaled within the first second of a maximal exhalation. This parameter can be expressed either in liters or as a percentage.

  4. Spirometric measurements (FEV1/FVC ratio)

    Time frame: Day 1

    It is employed to assess respiratory function and is measured with a spirometer. The value is obtained by dividing FEV₁ by FVC, and the result is expressed as a percentage.

  5. Carbon monoxide diffusion capacity

    Time frame: Day 1

    Carbon monoxide diffusion capacity (DLCO) is the measurement of the passage of carbon monoxide gas in inspired air into the lung capillary blood. Diffusion test is performed in the pulmonary function test laboratory.

  6. Gender-Age-Physiology (GAP) Index

    Time frame: Day 1

    The Gender-Age-Physiology (GAP) index is a multidimensional assessment index developed and validated to predict mortality in ILD. The ILD-GAP index is divided into stages 0-1, 2-3, 4-5, and >5, which predict the risk of death in the 1st, 2nd, and 3rd years. The GAP index will be calculated based on gender (0-1 points), age (0-2 points), %FVC (0-2 points), and %DLCO (0-3 points). It is classified into Stage I (0-3 points), Stage II (4-5 points), and Stage III (6-8 points), with prognosis worsening as it progresses from Stage I to Stage III.

  7. Modified Medical Research Council Dyspnea Score

    Time frame: Day 1

    The Modified Medical Research Council (mMRC) Dyspnea Scale assesses the sensation of breathlessness as perceived by the individual. The severity of dyspnea is scored on a scale ranging from 0 to 4, where 0 indicates no perception of dyspnea and 4 represents severe breathlessness.

  8. Handgrip Strength

    Time frame: Day 1

    A manual hydraulic dynamometer will be used for the hand grip strength test, taking into account the recommendations of the American Association of Occupational Therapists (AAOT). During the test, measurements will be taken while the patient is seated with back support, shoulder in adduction and neutral position, elbow at 90° flexion, and forearm in neutral position.

  9. Fatigue severity scale

    Time frame: Day 1

    he fatigue levels of individuals will be evaluated using the Fatigue Severity Scale. This scale comprises nine items rated on a 7-point Likert scale, reflecting the individual's perception of fatigue, which may indicate the need for medical intervention. The total score is 63. Higher scores indicate more severe fatigue.

  10. London Chest Daily Activities of Living Scale

    Time frame: Day 1

    The feeling of breathlessness experienced during daily living activities was assessed using the London Chest Daily Activities of Living Scale (LCADL). The scale consists of a total of 15 items divided into four sections: personal care (4 items), housework (6 items), physical activity (2 items), and leisure activities (3 items). Each item is scored on a scale of 0-5. The total score for the scale is 75. A high score indicates an increased perception of shortness of breath during daily living activities.

  11. Saint George Quality of life questionnaire

    Time frame: Day 1

    The St. George's Respiratory Questionnaire is designed to assess health-related quality of life in individuals with respiratory conditions. It provides four separate scores: Symptoms, Activity, Impacts, and an overall Total score. The scale ranges from 0 to 100, where 0 represents no impairment in quality of life and 100 indicates the most severe impairment.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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