Sit-to-stand and Peripheral Muscle Strength in COPD

NCT ID: NCT02487875

Last Updated: 2015-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-04-30

Brief 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.

Detailed 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.

Conditions

COPD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COPD patients -study group

COPD inpatients GOLD2-4, in stable conditions,hospitalized to follow a pulmonary rehabilitation programme. The study group performs in addition to the standard programme, also a peripheric muscle strength training

Group Type: EXPERIMENTAL

rehabilitation

Intervention Type: OTHER

COPD patients -control group

COPD inpatients GOLD2-4, in stable conditions,hospitalized to follow a pulmonary rehabilitation programme

Group Type: ACTIVE_COMPARATOR

rehabilitation

Intervention Type: OTHER

Interventions

rehabilitation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 87 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maugeri Foundation

OTHER

Sponsor Role: lead

Responsible Party

Andrea Zanini

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Maugeri di Tradate

Tradate, VA, Italy

Countries

Italy

Other Identifiers

Maugeri1

Identifier Type: -

Identifier Source: org_study_id