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

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ClinicalTrials.gov Identifier: NCT03627624
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Collaborators:
University of Parma
Ospedale Civico, Lugano
Università degli Studi dell'Insubria
Information provided by (Responsible Party):
elisabetta zampogna, Maugeri Foundation

Brief Summary:

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.


Condition or disease Intervention/treatment
COPD Other: Pulmonary rehabilitation

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.


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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Minimal Clinically Important Difference in 30 Second Sit-to-stand Test After Pulmonary Rehabilitation in Patients With COPD
Actual Study Start Date : March 16, 2018
Actual Primary Completion Date : March 16, 2018
Actual Study Completion Date : March 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation


Intervention Details:
  • Other: Pulmonary rehabilitation
    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 Outcome Measures :
  1. 30 STS test [ Time Frame: 21 days ]
    Minimally clinically important difference



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes 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.
Criteria

Inclusion Criteria:

  • diagnosis for COPD according to the GOLD criteria.
  • no exacerbations over the previous four weeks

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  • 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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627624


Locations
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Italy
ICS Maugeri
Tradate, Varese, Italy, 21049
Switzerland
EOC
Novaggio, Ticino, Switzerland, 6986
Sponsors and Collaborators
elisabetta zampogna
University of Parma
Ospedale Civico, Lugano
Università degli Studi dell'Insubria
Investigators
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Study Chair: Antonio Spanevello, Prof Maugeri Foundation

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: elisabetta zampogna, sub-investigator, Maugeri Foundation
ClinicalTrials.gov Identifier: NCT03627624     History of Changes
Other Study ID Numbers: Maugeri2
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by elisabetta zampogna, Maugeri Foundation:
MCID
30 STS test
Pulmonary rehabilitation