Sit-to-stand and Peripheral Muscle Strength in COPD

June 29, 2015 updated by: Andrea Zanini, Maugeri Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • VA
      • Tradate, VA, Italy, 21049
        • Fondazione Maugeri di Tradate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: rehabilitation
Active Comparator: COPD patients -control group
COPD inpatients GOLD2-4, in stable conditions,hospitalized to follow a pulmonary rehabilitation programme
Other: rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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).
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maugeri Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

July 2, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Maugeri1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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