Sit-to-stand and Peripheral Muscle Strength in COPD
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 25, 2015
CompletedFirst Posted
Study publicly available on registry
July 2, 2015
CompletedJuly 2, 2015
June 1, 2015
1.2 years
June 25, 2015
June 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
COPD patients -study group
EXPERIMENTALCOPD 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
COPD patients -control group
ACTIVE COMPARATORCOPD inpatients GOLD2-4, in stable conditions,hospitalized to follow a pulmonary rehabilitation programme
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Maugeri di Tradate
Tradate, VA, 21049, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 25, 2015
First Posted
July 2, 2015
Study Start
January 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
July 2, 2015
Record last verified: 2015-06