MCID in 30 STS Test After PR in COPD Patients

Completed

• Conditions: COPD

• Registration Number: NCT03627624
• Lead Sponsor: elisabetta zampogna

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.

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 Timeline

• Study Start: 2018-03-16
• Primary Completion: 2018-03-16
• Study First Submitted: 2018-07-06
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-13
• Study Completion: 2019-03-16
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30 STS test	21 days	Minimally clinically important difference

Trial Locations

Locations (2)

ICS Maugeri; 🇮🇹 Tradate, Varese, Italy

EOC; 🇨🇭 Novaggio, Ticino, Switzerland