MCID in 30 STS Test After PR in COPD Patients

COPD Clinical Trial

— COPD  

Official title:

Minimal Clinically Important Difference in 30 Second Sit-to-stand Test After Pulmonary Rehabilitation in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627624
• Other study ID #: Maugeri2
• Status: Completed
• Start date: March 16, 2018
• Est. completion date: March 16, 2019

Study information

• Verified date: March 2023
• Source: Maugeri Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 16, 2019
• Est. primary completion date: March 16, 2018
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• diagnosis for COPD according to the GOLD criteria.

• no exacerbations over the previous four weeks

• Page 3 of 3 -

• 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 -

Related Conditions & MeSH terms

• COPD

Intervention

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 (?) evaluation of 30-STST.

Locations

Country	Name	City	State
Italy	ICS Maugeri	Tradate	Varese
Switzerland	EOC	Novaggio	Ticino

Sponsors (4)

Lead Sponsor	Collaborator
elisabetta zampogna	Ospedale Civico, Lugano, Università degli Studi dell'Insubria, University of Parma

Countries where clinical trial is conducted

Italy,  Switzerland, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 STS test	Minimally clinically important difference	21 days