NCT02487875

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
Last Updated

July 2, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

June 25, 2015

Last Update Submit

June 29, 2015

Conditions

Keywords

Sit-to-stand testMuscle strengthPulmonary rehabilitation

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

EXPERIMENTAL

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

COPD patients -control group

ACTIVE COMPARATOR

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

Other: rehabilitation

Interventions

COPD patients -control groupCOPD patients -study group

Eligibility Criteria

Age18 Years - 87 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

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

Locations