MCID in 30 STS Test After PR in COPD Patients

NCT ID: NCT03627624

Last Updated: 2023-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-16

Study Completion Date

2019-03-16

Brief Summary

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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

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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.

Conditions

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COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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 -
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Parma

OTHER

Sponsor Role collaborator

Ospedale Civico, Lugano

OTHER_GOV

Sponsor Role collaborator

Università degli Studi dell'Insubria

OTHER

Sponsor Role collaborator

elisabetta zampogna

OTHER

Sponsor Role lead

Responsible Party

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elisabetta zampogna

sub-investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Antonio Spanevello, Prof

Role: STUDY_CHAIR

Maugeri Foundation

Locations

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ICS Maugeri

Tradate, Varese, Italy

Site Status

EOC

Novaggio, Canton Ticino, Switzerland

Site Status

Countries

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Italy Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 11719314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10194189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12108859 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12204863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20133927 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1549826 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31270178 (View on PubMed)

Other Identifiers

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Maugeri2

Identifier Type: -

Identifier Source: org_study_id

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