Chronic Obstructive Pulmonary Disease Clinical Trial
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
Verified date | July 2021 |
Source | Berner Reha Zentrum AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 55 |
Est. completion date | March 30, 2021 |
Est. primary completion date | March 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients with diagnosed COPD according to a forced expiratory volume in 1s (FEV1) / forced vital capacity (FVC) ratio below the lower limit of normal Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Berner Reha Zentrum | Heiligenschwendi | Bern |
Lead Sponsor | Collaborator |
---|---|
Thomas Riegler | University of Zurich |
Switzerland,
Crook S, Büsching 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). pii: 1601871. doi: 10.1183/13993003.01871-2016. Print 2017 Mar. — View Citation
Miller 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. Erratum in: Chest. 2011 Mar;139(3):733. — View Citation
Quanjer 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. — View Citation
Reychler 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. — View Citation
Yoshioka 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Oxygen saturation | Difference in oxygen saturation profiles between the two experimental conditions | During pulmonary rehabilitation, approximately 14 days | |
Other | Heart rate | Difference in heart rate profiles between the two experimental conditions | During pulmonary rehabilitation, approximately 14 days | |
Other | Ratings of perceived exertion | Difference in perceived exertion profiles between the two experimental conditions measured with the category ratio - 10 Borg scale (0-10) | During pulmonary rehabilitation, approximately 14 days | |
Other | Ratings of perceived breathlessness | Difference in perceived breathlessness profiles between the two experimental conditions measured with the category ratio - 10 Borg scale (0-10) | During pulmonary rehabilitation, approximately 14 days | |
Other | Incorrectly performed repetitions during the 1-min STS test | The number of incorrectly performed repetitions during th 1-min STS test | During pulmonary rehabilitation, approximately 14 days | |
Other | Questionnaire about the patient's preferences during the 1-min sit to stand test | Multiple choice questions about patient reported perception concerning sitting position, chair height, perceived difficulties during the 1-min sit to stand test. | During pulmonary rehabilitation, approximately 14 days | |
Primary | 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 | During pulmonary rehabilitation, approximately 14 days | |
Secondary | 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.) | During pulmonary rehabilitation, approximately 14 days |
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