COPDNCT04579055
Impact of Chair Seat Height on the 1-Minute Sit to Stand Test Performance in Chronic Obstructive Pulmonary Disease
A study testing 1-min STS test: adjusted and 1-min STS test: standardized in people with COPD and Chronic Obstructive Pulmonary Disease, run by Thomas Riegler at 1 site in Switzerland.
Trial summary
The 1-minute sit to stand (1-min STS) test is a standardized test which is used to examine exercise capacity in patients with chronic obstructive pulmonary disease (COPD). The chair seat height used is standardized to 46-48 cm. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- 1-min STS test: adjusted and 1-min STS test: standardized
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Sep 2020to 30 Mar 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with diagnosed COPD according to a forced expiratory volume in 1s (FEV1) / forced vital capacity (FVC) ratio below the lower limit of normal
Who cannot join
- Patients who are not able to bend their knees while sitting on a standard chair (i.e., knee flexion less than 90°)
- Patients who are not able to understand the instructions of the 1-min STS test, either of language or cognitive reasons
- Patients who are unable to perform the STS test due to functional disability (i.e., being not able to rise from a chair without hand support), previous surgery, or pain according to the judgement of the responsible physician.
- Patients who did not sign the informed consent form
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Berner Reha Zentrum
Heiligenschwendi, Canton of Bern, 3625
About this study
Official title: The Impact of Chair Seat Height on the 1-Minute Sit to Stand Test Performance in Chronic Obstructive Pulmonary Disease: a Randomized Cross-over Study
The 1-minute sit to stand (1-min STS) test is a standardized test which is used to examine exercise capacity in patients with chronic obstructive pulmonary disease (COPD). The chair seat height used is standardized to 46-48 cm. Using a standard seat height for all patients - irrespective of their body height - may lead to invalid estimates of functional exercise capacity. The objective of this study is to assess whether there is a difference in repetitions during the 1-min STS test if the seat height is adjusted to 90° knee joint angle or the standard height chair of 46 cm is used.
Read the detailed description
In a single-center, randomized crossover study, the investigators aim to elucidate whether there is a difference in repetitions during the 1-min STS test if the seat height is adjusted to 90° knee joint angle or the standard height chair of 46 cm is used.
Patients with COPD referred for pulmonary rehabilitation will be invited to perform one standardised- (chair seat height 46cm) and one individualized (chair seat height adapted to 90° knee flexion) 1-min STS test on two different days in random order.
The tests will be performed after patients are familiarised with the 1-min STS testing procedure and learning effects can be excluded.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Being tested
- 1-min STS test: adjusted, 1-min STS test: standardized
- Keywords
- 1-minute Sit to Stand Test, chair seat height
- 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.
1-min STS test: adjustedOther
Individually adjusted chair seat height of 90° knee joint flexion
1-min STS test: standardizedOther
Standardized chair seat height of 46 cm
| Study group | Role | What they receive |
|---|---|---|
| 1-min STS test: chair seat height adjusted to 90° knee flexion | Experimental | In this experimental condition, the patient performs the 1-minute sit to stand test on an individually adjusted seat height of 90° knee joint flexion. Receives: Other: 1-min STS test: adjusted |
| 1-min STS test: chair seat height standardized of 46cm | Active comparator | In this experimental condition, the patient performs the 1-minute sit to stand test on a standard height chair of 46cm. Receives: Other: 1-min STS test: standardized |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of repetitions in the 1-min STS test
difference in the amount of sit to stand repetitions in the 1-min STS test from a standard chair (46cm) or an individualized seat height chair of 90° knee joint angle
Measured: During pulmonary rehabilitation, approximately 14 days
Secondary outcomes (1)
Sit to stand power index
The sit to stand power index is used to calculate the force-generating capacity (in watt) of the knee extensor muscles and is defined as: (leg length (in m) - seat height (in m)) x body mass x acceleration of gravity x sit to stand repetitions / time (sit-stand) (in sec.)
Measured: During pulmonary rehabilitation, approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start16 Sep 2020
- Primary completion25 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Riegler
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Thomas Riegler, Berner Reha Zentrum AG
- Investigators
- Thomas Riegler, MSc, Principal investigator, Berner Reha Zentrum, HeiligenschwendiThomas Radtke, PD, Dr phil, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579055
- Sponsor's protocol ID
- 2020-01677
- Status last verified
- Jul 2021
- First submitted
- 1 Oct 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crook S, Busching G, Schultz K, Lehbert N, Jelusic D, Keusch S, Wittmann M, Schuler M, Radtke T, Frey M, Turk A, Puhan MA, Frei A. A multicentre validation of the 1-min sit-to-stand test in patients with COPD. Eur Respir J. 2017 Mar 2;49(3):1601871. doi: 10.1183/13993003.01871-2016. Print 2017 Mar.
PubMed 28254766Yoshioka S, Nagano A, Hay DC, Fukashiro S. Peak hip and knee joint moments during a sit-to-stand movement are invariant to the change of seat height within the range of low to normal seat height. Biomed Eng Online. 2014 Mar 12;13(1):27. doi: 10.1186/1475-925X-13-27.
PubMed 24620992Reychler G, Boucard E, Peran L, Pichon R, Le Ber-Moy C, Ouksel H, Liistro G, Chambellan A, Beaumont M. One minute sit-to-stand test is an alternative to 6MWT to measure functional exercise performance in COPD patients. Clin Respir J. 2018 Mar;12(3):1247-1256. doi: 10.1111/crj.12658. Epub 2017 Jun 15.
PubMed 28621019Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
PubMed 22743675Miller MR, Quanjer PH, Swanney MP, Ruppel G, Enright PL. Interpreting lung function data using 80% predicted and fixed thresholds misclassifies more than 20% of patients. Chest. 2011 Jan;139(1):52-9. doi: 10.1378/chest.10-0189. Epub 2010 Jun 3.
PubMed 20522571
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chair Seat Height on the 1-Minute Sit to Stand Test Performance in Chronic Obstructive Pulmonary Disease: a Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT04579055
- Acronym / sponsor ID
- 2020-01677
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Keywords
- 1-minute Sit to Stand Test, chair seat height
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Thomas RieglerUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 8 Oct 2020 (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 1-minute sit to stand (1-min STS) test is a standardized test which is used to examine exercise capacity in patients with chronic obstructive pulmonary disease (COPD). The chair seat height used is standardized to 46-48 cm. Using a standard seat height for all patients - irrespective of their body height - may lead to invalid estimates of functional exercise capacity. The objective of this study is to assess whether there is a difference in repetitions during the 1-min STS test if the seat height is adjusted to 90° knee joint angle or the standard height chair of 46 cm is used.
Detailed description
In a single-center, randomized crossover study, the investigators aim to elucidate whether there is a difference in repetitions during the 1-min STS test if the seat height is adjusted to 90° knee joint angle or the standard height chair of 46 cm is used.
Patients with COPD referred for pulmonary rehabilitation will be invited to perform one standardised- (chair seat height 46cm) and one individualized (chair seat height adapted to 90° knee flexion) 1-min STS test on two different days in random order.
The tests will be performed after patients are familiarised with the 1-min STS testing procedure and learning effects can be excluded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-min STS test: chair seat height adjusted to 90° knee flexion | Experimental | Other: 1-min STS test: adjustedIn this experimental condition, the patient performs the 1-minute sit to stand test on an individually adjusted seat height of 90° knee joint flexion. |
| 1-min STS test: chair seat height standardized of 46cm | Active comparator | Other: 1-min STS test: standardizedIn this experimental condition, the patient performs the 1-minute sit to stand test on a standard height chair of 46cm. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with diagnosed COPD according to a forced expiratory volume in 1s (FEV1) / forced vital capacity (FVC) ratio below the lower limit of normal
Key exclusion criteria (4 listed)
- Patients who are not able to bend their knees while sitting on a standard chair (i.e., knee flexion less than 90°)
- Patients who are not able to understand the instructions of the 1-min STS test, either of language or cognitive reasons
- Patients who are unable to perform the STS test due to functional disability (i.e., being not able to rise from a chair without hand support), previous surgery, or pain according to the judgement of the responsible physician.
- Patients who did not sign the informed consent form
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 |
|---|---|---|
| 1-min STS test: adjustedIndividually adjusted chair seat height of 90° knee joint flexion | Other | 1-min STS test: chair seat height adjusted to 90° knee flexion |
| 1-min STS test: standardizedStandardized chair seat height of 46 cm | Other | 1-min STS test: chair seat height standardized of 46cm |
Primary outcome
Number of repetitions in the 1-min STS test
Time frame: During pulmonary rehabilitation, approximately 14 days
difference in the amount of sit to stand repetitions in the 1-min STS test from a standard chair (46cm) or an individualized seat height chair of 90° knee joint angle
1 secondary outcome
Sit to stand power index
Time frame: During pulmonary rehabilitation, approximately 14 days
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 21 Jul 2021.
- Background: PubMed 28254766Crook S, Busching G, Schultz K, Lehbert N, Jelusic D, Keusch S, Wittmann M, Schuler M, Radtke T, Frey M, Turk A, Puhan MA, Frei A. A multicentre validation of the 1-min sit-to-stand test in patients with COPD. Eur Respir J. 2017 Mar 2;49(3):1601871. doi: 10.1183/13993003.01871-2016. Print 2017 Mar.
- Background: PubMed 24620992Yoshioka S, Nagano A, Hay DC, Fukashiro S. Peak hip and knee joint moments during a sit-to-stand movement are invariant to the change of seat height within the range of low to normal seat height. Biomed Eng Online. 2014 Mar 12;13(1):27. doi: 10.1186/1475-925X-13-27.
- Background: PubMed 28621019Reychler G, Boucard E, Peran L, Pichon R, Le Ber-Moy C, Ouksel H, Liistro G, Chambellan A, Beaumont M. One minute sit-to-stand test is an alternative to 6MWT to measure functional exercise performance in COPD patients. Clin Respir J. 2018 Mar;12(3):1247-1256. doi: 10.1111/crj.12658. Epub 2017 Jun 15.
- Background: PubMed 22743675Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
- Background: PubMed 20522571Miller MR, Quanjer PH, Swanney MP, Ruppel G, Enright PL. Interpreting lung function data using 80% predicted and fixed thresholds misclassifies more than 20% of patients. Chest. 2011 Jan;139(1):52-9. doi: 10.1378/chest.10-0189. Epub 2010 Jun 3.
- Individual participant dataSharing planned: No
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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.
Thomas Riegler, MSc principal investigator
Berner Reha Zentrum, Heiligenschwendi
Thomas Radtke, PD, Dr phil principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-min STS test: adjusted and 1-min STS test: standardized in people with COPD and Chronic Obstructive Pulmonary Disease, run by Thomas Riegler at 1 site in Switzerland.
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 1 inclusion and 4 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 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Number of repetitions in the 1-min STS test (time frame: During pulmonary rehabilitation, approximately 14 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 NCT04579055, which also lists 5 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 21 Jul 2021.