Clinical trial NCT03627624: MCID in 30 STS Test After PR in COPD Patients
Official title: Minimal Clinically Important Difference in 30 Second Sit-to-stand Test After Pulmonary Rehabilitation in Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: MCID
30 STS test
Pulmonary rehabilitation
Lead sponsor: Maugeri Foundation
Sponsor class: OTHER
Collaborators: name: University of Parma
name: Ospedale Civico, Lugano
name: Università degli Studi dell'Insubria
First posted: 2018-08-13
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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 -

Primary outcomes:
measure: 30 STS test
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tradate
country: Italy
facility: ICS Maugeri
state: Varese
city: Novaggio
country: Switzerland
facility: EOC
state: Ticino
Study officials:
affiliation: Maugeri Foundation
name: Antonio Spanevello, Prof
role: STUDY_CHAIR
References:
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citation: Skeletal muscle dysfunction in chronic obstructive pulmonary disease. A statement of the American Thoracic Society and European Respiratory Society. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 2):S1-40. doi: 10.1164/ajrccm.159.supplement_1.99titlepage. No abstract available.
citation: Spruit MA, Gosselink R, Troosters T, De Paepe K, Decramer M. Resistance versus endurance training in patients with COPD and peripheral muscle weakness. Eur Respir J. 2002 Jun;19(6):1072-8. doi: 10.1183/09031936.02.00287102.
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citation: Troosters T, Probst VS, Crul T, Pitta F, Gayan-Ramirez G, Decramer M, Gosselink R. Resistance training prevents deterioration in quadriceps muscle function during acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 May 15;181(10):1072-7. doi: 10.1164/rccm.200908-1203OC. Epub 2010 Feb 4.
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citation: Zanini A, Crisafulli E, D'Andria M, Gregorini C, Cherubino F, Zampogna E, Azzola A, Spanevello A, Schiavone N, Chetta A. Minimum Clinically Important Difference in 30-s Sit-to-Stand Test After Pulmonary Rehabilitation in Subjects With COPD. Respir Care. 2019 Oct;64(10):1261-1269. doi: 10.4187/respcare.06694. Epub 2019 Jul 3.