COPDCOPDNCT03627624
MCID in 30 STS Test After PR in COPD Patients
An observational study of COPD, run by elisabetta zampogna at 2 sites in 2 countries.
Trial summary
The sit-to-stand test (STST) is a feasible alternative for measuring peripheral muscle strength of the lower limbs. Our aim was to evaluate, in Chronic Obstructive Pulmonary Disease (COPD) patients, the minimal clinically important difference (MCID) of 30-second STST (30-STST) after pulmonary rehabilitation (PR). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- Pulmonary rehabilitation
- How many people
- 96 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Mar 2018to 16 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Adult, Older adult
Study population: We examined 96 patients with COPD who attended an inpatient PR program. All patients had a diagnosis for COPD according to the GOLD criteria.Patients who had acute exacerbation over the previous four weeks were excluded. Patients who did not complete the PR program, for intercurrent COPD exacerbation, or any unstable medical condition, were also excluded. Contraindications for participation in the PR program included musculoskeletal disorders, malignant diseases, unstable cardiac condition, and lack of adherence to the program. All patients had smoking history ≥10 pack years and received regular treatment with inhaled bronchodilators and inhaled steroids according to current guidelines for their disease stage.
Who may be able to join
- diagnosis for COPD according to the GOLD criteria.
- no exacerbations over the previous four weeks
- Page 3 of 3 -
- completing PR program
- smoking history ≥10 pack years
- regular treatment with inhaled bronchodilators and inhaled steroids
Who cannot join
- 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 -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Minimal Clinically Important Difference in 30 Second Sit-to-stand Test After Pulmonary Rehabilitation in Patients With COPD
The sit-to-stand test (STST) is a feasible alternative for measuring peripheral muscle strength of the lower limbs.
Our aim was to evaluate, in Chronic Obstructive Pulmonary Disease (COPD) patients, the minimal clinically important difference (MCID) of 30-second STST (30-STST) after pulmonary rehabilitation (PR).
Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST. The MCID was evaluated using an anchor-based method.
Read the detailed description
The sit-to-stand test (STST) is a feasible alternative for measuring peripheral muscle strength of the lower limbs used as standard test at the beginning and at the end of pulmonary rehabilitation programme.
Our aim was to retrospectively evaluate, in Chronic Obstructive Pulmonary Disease (COPD) patients, the minimal clinically important difference (MCID) of 30-second STST (30-STST) after pulmonary rehabilitation (PR).
Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST. The MCID was evaluated using an anchor-based method.
- Conditions
- COPD
- Being tested
- Pulmonary rehabilitation
- Keywords
- MCID, 30 STS test, Pulmonary rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitationOther
Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST.
What is being measured
The primary outcome is the main question the study is designed to answer.
30 STS test
Minimally clinically important difference
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start16 Mar 2018
- Primary completion16 Mar 2018
- Study completion16 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- elisabetta zampogna
- Sponsor type
- University, hospital or other
- Collaborators
- University of Parma, Ospedale Civico, Lugano, Università degli Studi dell'Insubria
- Responsible party
- Sponsor-investigator, elisabetta zampogna, Maugeri Foundation
- Investigators
- Antonio Spanevello, Prof, Study chair, Maugeri Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627624
- Sponsor's protocol ID
- Maugeri2
- Acronym
- COPD
- Status last verified
- Mar 2023
- First submitted
- 6 Jul 2018
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Debigare R, Cote CH, Maltais F. Peripheral muscle wasting in chronic obstructive pulmonary disease. Clinical relevance and mechanisms. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1712-7. doi: 10.1164/ajrccm.164.9.2104035. No abstract available.
PubMed 11719314Skeletal muscle dysfunction in chronic obstructive pulmonary disease. A statement of the American Thoracic Society and European Respiratory Society. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 2):S1-40. doi: 10.1164/ajrccm.159.supplement_1.99titlepage. No abstract available.
PubMed 10194189Spruit MA, Gosselink R, Troosters T, De Paepe K, Decramer M. Resistance versus endurance training in patients with COPD and peripheral muscle weakness. Eur Respir J. 2002 Jun;19(6):1072-8. doi: 10.1183/09031936.02.00287102.
PubMed 12108859Ortega F, Toral J, Cejudo P, Villagomez R, Sanchez H, Castillo J, Montemayor T. Comparison of effects of strength and endurance training in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2002 Sep 1;166(5):669-74. doi: 10.1164/rccm.2107081.
PubMed 12204863Troosters T, Probst VS, Crul T, Pitta F, Gayan-Ramirez G, Decramer M, Gosselink R. Resistance training prevents deterioration in quadriceps muscle function during acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 May 15;181(10):1072-7. doi: 10.1164/rccm.200908-1203OC. Epub 2010 Feb 4.
PubMed 20133927Simpson K, Killian K, McCartney N, Stubbing DG, Jones NL. Randomised controlled trial of weightlifting exercise in patients with chronic airflow limitation. Thorax. 1992 Feb;47(2):70-5. doi: 10.1136/thx.47.2.70.
PubMed 1549826Zanini A, Crisafulli E, D'Andria M, Gregorini C, Cherubino F, Zampogna E, Azzola A, Spanevello A, Schiavone N, Chetta A. Minimum Clinically Important Difference in 30-s Sit-to-Stand Test After Pulmonary Rehabilitation in Subjects With COPD. Respir Care. 2019 Oct;64(10):1261-1269. doi: 10.4187/respcare.06694. Epub 2019 Jul 3.
PubMed 31270178
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Clinically Important Difference in 30 Second Sit-to-stand Test After Pulmonary Rehabilitation in Patients With COPD
- ClinicalTrials.gov ID
- NCT03627624
- Acronym / sponsor ID
- COPD / Maugeri2
- Conditions
- COPD
- Keywords
- MCID, 30 STS test, Pulmonary rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- elisabetta zampognaUniversity, hospital or other
- Collaborators
- University of Parma, Ospedale Civico, Lugano, Università degli Studi dell'Insubria
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- 16 Mar 2019 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The sit-to-stand test (STST) is a feasible alternative for measuring peripheral muscle strength of the lower limbs.
Our aim was to evaluate, in Chronic Obstructive Pulmonary Disease (COPD) patients, the minimal clinically important difference (MCID) of 30-second STST (30-STST) after pulmonary rehabilitation (PR).
Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST. The MCID was evaluated using an anchor-based method.
Detailed description
The sit-to-stand test (STST) is a feasible alternative for measuring peripheral muscle strength of the lower limbs used as standard test at the beginning and at the end of pulmonary rehabilitation programme.
Our aim was to retrospectively evaluate, in Chronic Obstructive Pulmonary Disease (COPD) patients, the minimal clinically important difference (MCID) of 30-second STST (30-STST) after pulmonary rehabilitation (PR).
Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST. The MCID was evaluated using an anchor-based method.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- We examined 96 patients with COPD who attended an inpatient PR program. All patients had a diagnosis for COPD according to the GOLD criteria.Patients who had acute exacerbation over the previous four weeks were excluded. Patients who did not complete the PR program, for intercurrent COPD exacerbation, or any unstable medical condition, were also excluded. Contraindications for participation in the PR program included musculoskeletal disorders, malignant diseases, unstable cardiac condition, and lack of adherence to the program. All patients had smoking history ≥10 pack years and received regular treatment with inhaled bronchodilators and inhaled steroids according to current guidelines for their disease stage.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitationStable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST. | Other | – |
Primary outcome
30 STS test
Time frame: 21 days
Minimally clinically important difference
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 11719314Debigare R, Cote CH, Maltais F. Peripheral muscle wasting in chronic obstructive pulmonary disease. Clinical relevance and mechanisms. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1712-7. doi: 10.1164/ajrccm.164.9.2104035. No abstract available.
- Background: PubMed 10194189Skeletal muscle dysfunction in chronic obstructive pulmonary disease. A statement of the American Thoracic Society and European Respiratory Society. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 2):S1-40. doi: 10.1164/ajrccm.159.supplement_1.99titlepage. No abstract available.
- Background: PubMed 12108859Spruit MA, Gosselink R, Troosters T, De Paepe K, Decramer M. Resistance versus endurance training in patients with COPD and peripheral muscle weakness. Eur Respir J. 2002 Jun;19(6):1072-8. doi: 10.1183/09031936.02.00287102.
- Background: PubMed 12204863Ortega F, Toral J, Cejudo P, Villagomez R, Sanchez H, Castillo J, Montemayor T. Comparison of effects of strength and endurance training in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2002 Sep 1;166(5):669-74. doi: 10.1164/rccm.2107081.
- Background: PubMed 20133927Troosters T, Probst VS, Crul T, Pitta F, Gayan-Ramirez G, Decramer M, Gosselink R. Resistance training prevents deterioration in quadriceps muscle function during acute exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 May 15;181(10):1072-7. doi: 10.1164/rccm.200908-1203OC. Epub 2010 Feb 4.
- Background: PubMed 1549826Simpson K, Killian K, McCartney N, Stubbing DG, Jones NL. Randomised controlled trial of weightlifting exercise in patients with chronic airflow limitation. Thorax. 1992 Feb;47(2):70-5. doi: 10.1136/thx.47.2.70.
- Derived from this study: PubMed 31270178Zanini A, Crisafulli E, D'Andria M, Gregorini C, Cherubino F, Zampogna E, Azzola A, Spanevello A, Schiavone N, Chetta A. Minimum Clinically Important Difference in 30-s Sit-to-Stand Test After Pulmonary Rehabilitation in Subjects With COPD. Respir Care. 2019 Oct;64(10):1261-1269. doi: 10.4187/respcare.06694. Epub 2019 Jul 3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Spanevello, Prof study chair
Maugeri Foundation
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by elisabetta zampogna at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 STS test (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03627624, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.