MCID in 30 STS Test After PR in COPD Patients (COPD)

March 2, 2023 updated by: elisabetta zampogna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Varese
      • Tradate, Varese, Italy, 21049
        • ICS Maugeri
  • Switzerland
    • Ticino
      • Novaggio, Ticino, Switzerland, 6986
        • EOC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We examined 96 patients with COPD who attended an inpatient PR program. All patients had a diagnosis for COPD according to the GOLD criteria.Patients who had acute exacerbation over the previous four weeks were excluded. Patients who did not complete the PR program, for intercurrent COPD exacerbation, or any unstable medical condition, were also excluded. Contraindications for participation in the PR program included musculoskeletal disorders, malignant diseases, unstable cardiac condition, and lack of adherence to the program. All patients had smoking history ≥10 pack years and received regular treatment with inhaled bronchodilators and inhaled steroids according to current guidelines for their disease stage.

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 STS test
Time Frame: 21 days
Minimally clinically important difference
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

elisabetta zampogna

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2018

Primary Completion (Actual)

March 16, 2018

Study Completion (Actual)

March 16, 2019

Study Registration Dates

First Submitted

July 6, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (Actual)

August 13, 2018

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Maugeri2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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