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OpenTrials
Completed

NCT Number: NCT03627624

MCID in 30 STS Test After PR in COPD Patients

The sit-to-stand test (STST) is a feasible alternative for measuring peripheral muscle strength of the lower limbs.

Our aim was to evaluate, in Chronic Obstructive Pulmonary Disease (COPD) patients, the minimal clinically important difference (MCID) of 30-second STST (30-STST) after pulmonary rehabilitation (PR).

Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST. The MCID was evaluated using an anchor-based method.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ICS Maugeri, Tradate, Varese, Italy

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About this study

The sit-to-stand test (STST) is a feasible alternative for measuring peripheral muscle strength of the lower limbs used as standard test at the beginning and at the end of pulmonary rehabilitation programme.

Our aim was to retrospectively evaluate, in Chronic Obstructive Pulmonary Disease (COPD) patients, the minimal clinically important difference (MCID) of 30-second STST (30-STST) after pulmonary rehabilitation (PR).

Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST. The MCID was evaluated using an anchor-based method.

Who can participate

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

Inclusion criteria

  • diagnosis for COPD according to the GOLD criteria.
  • no exacerbations over the previous four weeks
  • Page 3 of 3 -
  • completing PR program
  • smoking history ≥10 pack years
  • regular treatment with inhaled bronchodilators and inhaled steroids

Exclusion criteria

  • any unstable medical condition
  • Contraindications for participation in the PR program included musculoskeletal disorders, malignant diseases, unstable cardiac condition, and lack of adherence to the program -

Treatment and study plan

Pulmonary Rehabilitation

Other

Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST.

Primary outcomes

  1. 30 STS test

    Time frame: 21 days

    Minimally clinically important difference

Sponsors and collaborators

Lead sponsor

elisabetta zampogna

Other

Collaborators

  • Ospedale Civico, Lugano
  • University of Parma
  • Università degli Studi dell'Insubria

Registry information

Official study title

Minimal Clinically Important Difference in 30 Second Sit-to-stand Test After Pulmonary Rehabilitation in Patients With COPD

Acronym: COPD

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 13, 2018
Registry last updated
Mar 6, 2023

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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