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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04579055
Other study ID # 2020-01677
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2020
Est. completion date March 30, 2021

Study information

Verified date July 2021
Source Berner Reha Zentrum AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
1-min STS test: adjusted
Individually adjusted chair seat height of 90° knee joint flexion
1-min STS test: standardized
Standardized chair seat height of 46 cm

Locations

Country Name City State
Switzerland Berner Reha Zentrum Heiligenschwendi Bern

Sponsors (2)

Lead Sponsor Collaborator
Thomas Riegler University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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

Outcome

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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