Sit-to-stand and Peripheral Muscle Strength in COPD

COPD Clinical Trial

Official title:

The One Repetition Maximum Test and the Sit-to-stand Test in the Assessment of a Specific Pulmonary Rehabilitation Program on Peripheral Muscle Strength in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487875
• Other study ID #: Maugeri1
• Status: Completed
• Phase: N/A
• First received: June 25, 2015
• Last updated: June 29, 2015
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Maugeri Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy:Fondazione Maugeri IEC
• Study type: Interventional

Clinical Trial Summary

Background: Individuals with COPD may present reduced peripheral muscle strength, which leads to impaired mobility. Comprehensive pulmonary rehabilitation (PR) should include strength training, in particular to lower limbs. Furthermore, simple tools for the assessment of lower extremity muscles' performance are required. Objectives: To assess the muscle strength of COPD patients by the sit-to-stand test (STST) as compared to the one-repetition maximum (1-RM), considered as the gold standard in non-laboratory situations, and to evaluate the responsiveness of STST to a PR program with specific strength training (SPR), compared to usual PR program (UPR). Methods: 60 moderate-to-severe COPD inpatients were randomly included into either the SPR or into the UPR. 30-sec STST, 1-min STST, 1-RM and 6MWT were assessed before and after PRs.

Description:

Background: Individuals with COPD may present reduced peripheral muscle strength, which leads to impaired mobility. Comprehensive pulmonary rehabilitation (PR) should include strength training, in particular to lower limbs. Furthermore, simple tools for the assessment of lower extremity muscles' performance are required. Objectives: To assess the muscle strength of COPD patients by the sit-to-stand test (STST) as compared to the one-repetition maximum (1-RM), considered as the gold standard in non-laboratory situations, and to evaluate the responsiveness of STST to a PR program with specific strength training (SPR), compared to usual PR program (UPR). Methods: 60 moderate-to-severe COPD inpatients were randomly included into either the SPR or into the UPR. 30-sec STST, 1-min STST, 1-RM and 6MWT were assessed before and after PRs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 87 Years

Eligibility

Inclusion Criteria:

• diagnosis for COPD according to the GOLD criteria.

• no exacerbations over the previous four weeks

• 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• rehabilitation

Locations

Country	Name	City	State
Italy	Fondazione Maugeri di Tradate	Tradate	VA

Sponsors (1)

Lead Sponsor	Collaborator
Maugeri Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the lower limbs' muscle strength by two STSTs (30-sec and 1-min), as compared to the 1-RM in patients with clinically stable COPD, both at baseline and after a PR with specific lower limbs' muscle strength training (SPR).		1 month	Yes