- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04579055
Impact of Chair Seat Height on the 1-Minute Sit to Stand Test Performance in Chronic Obstructive Pulmonary Disease
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bern
-
Heiligenschwendi, Bern, Switzerland, 3625
- Berner Reha Zentrum
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1-min STS test: chair seat height adjusted to 90° knee flexion
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.
|
Individually adjusted chair seat height of 90° knee joint flexion
|
|
Active Comparator: 1-min STS test: chair seat height standardized of 46cm
In this experimental condition, the patient performs the 1-minute sit to stand test on a standard height chair of 46cm.
|
Standardized chair seat height of 46 cm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
During pulmonary rehabilitation, approximately 14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sit to stand power index
Time Frame: During pulmonary rehabilitation, approximately 14 days
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen saturation
Time Frame: During pulmonary rehabilitation, approximately 14 days
|
Difference in oxygen saturation profiles between the two experimental conditions
|
During pulmonary rehabilitation, approximately 14 days
|
|
Heart rate
Time Frame: During pulmonary rehabilitation, approximately 14 days
|
Difference in heart rate profiles between the two experimental conditions
|
During pulmonary rehabilitation, approximately 14 days
|
|
Ratings of perceived exertion
Time Frame: During pulmonary rehabilitation, approximately 14 days
|
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
|
|
Ratings of perceived breathlessness
Time Frame: During pulmonary rehabilitation, approximately 14 days
|
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
|
|
Incorrectly performed repetitions during the 1-min STS test
Time Frame: During pulmonary rehabilitation, approximately 14 days
|
The number of incorrectly performed repetitions during th 1-min STS test
|
During pulmonary rehabilitation, approximately 14 days
|
|
Questionnaire about the patient's preferences during the 1-min sit to stand test
Time Frame: During pulmonary rehabilitation, approximately 14 days
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Riegler, MSc, Berner Reha Zentrum, Heiligenschwendi
- Principal Investigator: Thomas Radtke, PD, Dr phil, University of Zurich
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-01677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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