MCID in 30 STS Test After PR in COPD Patients

NCT03627624 | Completed DMC

• 1 other identifier: Maugeri2
• Study Type: observational
• Target: 96
• Locations: 2 countries
• Sites: 2

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.

Conditions

COPD

Keywords

MCID; 30 STS test; Pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• 30 STS test

  Minimally clinically important difference

  21 days

Interventions

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.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• elisabetta zampogna: lead
• University of Parma: collaborator
• Ospedale Civico, Lugano: collaborator
• Università degli Studi dell'Insubria: collaborator

Study Sites (2)

ICS Maugeri

Tradate, Varese, 21049, Italy

Location

EOC

Novaggio, Canton Ticino, 6986, Switzerland

Location

Related Publications (7)

• Debigare R, Cote CH, Maltais F. Peripheral muscle wasting in chronic obstructive pulmonary disease. Clinical relevance and mechanisms. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1712-7. doi: 10.1164/ajrccm.164.9.2104035. No abstract available.

  PMID: 11719314 BACKGROUND

• 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.

  PMID: 10194189 BACKGROUND

• 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.

  PMID: 12108859 BACKGROUND

• Ortega F, Toral J, Cejudo P, Villagomez R, Sanchez H, Castillo J, Montemayor T. Comparison of effects of strength and endurance training in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2002 Sep 1;166(5):669-74. doi: 10.1164/rccm.2107081.

  PMID: 12204863 BACKGROUND

• 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.

  PMID: 20133927 BACKGROUND

• Simpson K, Killian K, McCartney N, Stubbing DG, Jones NL. Randomised controlled trial of weightlifting exercise in patients with chronic airflow limitation. Thorax. 1992 Feb;47(2):70-5. doi: 10.1136/thx.47.2.70.

  PMID: 1549826 BACKGROUND

• 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.

  PMID: 31270178 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Antonio Spanevello, Prof

  Maugeri Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: sub-investigator

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: August 13, 2018
• Study Start: March 16, 2018
• Primary Completion: March 16, 2018
• Study Completion: March 16, 2019
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

IT (1); CH (1)