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Impact of Chair Seat Height on the 1-Minute Sit to Stand Test Performance in Chronic Obstructive Pulmonary Disease

Primary Purpose

COPD, Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

1-min STS test: adjusted

1-min STS test: standardized

About this trial

This is an interventional other trial for COPD focused on measuring 1-minute Sit to Stand Test, chair seat height

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Berner Reha Zentrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1-min STS test: chair seat height adjusted to 90° knee flexion

1-min STS test: chair seat height standardized of 46cm

Arm Description

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.

In this experimental condition, the patient performs the 1-minute sit to stand test on a standard height chair of 46cm.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.)

Full Information

NCT ID

NCT04579055

First Posted

October 1, 2020

Last Updated

July 20, 2021

Sponsor

Thomas Riegler

Collaborators

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT04579055

Brief Title

Impact of Chair Seat Height on the 1-Minute Sit to Stand Test Performance in Chronic Obstructive Pulmonary Disease

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

September 16, 2020 (Actual)

Primary Completion Date

March 25, 2021 (Actual)

Study Completion Date

March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Thomas Riegler

Collaborators

University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Chronic Obstructive Pulmonary Disease

Keywords

1-minute Sit to Stand Test, chair seat height

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1-min STS test: chair seat height adjusted to 90° knee flexion

Arm Type

Experimental

Arm Description

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.

Arm Title

1-min STS test: chair seat height standardized of 46cm

Arm Type

Active Comparator

Arm Description

In this experimental condition, the patient performs the 1-minute sit to stand test on a standard height chair of 46cm.

Intervention Type

Other

Intervention Name(s)

1-min STS test: adjusted

Intervention Description

Individually adjusted chair seat height of 90° knee joint flexion

Intervention Type

Other

Intervention Name(s)

1-min STS test: standardized

Intervention Description

Standardized chair seat height of 46 cm

Primary Outcome Measure Information:

Title

Number of repetitions in the 1-min STS test

Description

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

Time Frame

During pulmonary rehabilitation, approximately 14 days

Secondary Outcome Measure Information:

Title

Sit to stand power index

Description

Time Frame

During pulmonary rehabilitation, approximately 14 days

Other Pre-specified Outcome Measures:

Title

Oxygen saturation

Description

Difference in oxygen saturation profiles between the two experimental conditions

Time Frame

During pulmonary rehabilitation, approximately 14 days

Title

Heart rate

Description

Difference in heart rate profiles between the two experimental conditions

Time Frame

During pulmonary rehabilitation, approximately 14 days

Title

Ratings of perceived exertion

Description

Difference in perceived exertion profiles between the two experimental conditions measured with the category ratio - 10 Borg scale (0-10)

Time Frame

During pulmonary rehabilitation, approximately 14 days

Title

Ratings of perceived breathlessness

Description

Difference in perceived breathlessness profiles between the two experimental conditions measured with the category ratio - 10 Borg scale (0-10)

Time Frame

During pulmonary rehabilitation, approximately 14 days

Title

Incorrectly performed repetitions during the 1-min STS test

Description

The number of incorrectly performed repetitions during th 1-min STS test

Time Frame

During pulmonary rehabilitation, approximately 14 days

Title

Questionnaire about the patient's preferences during the 1-min sit to stand test

Description

Multiple choice questions about patient reported perception concerning sitting position, chair height, perceived difficulties during the 1-min sit to stand test.

Time Frame

During pulmonary rehabilitation, approximately 14 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Riegler, MSc

Organizational Affiliation

Berner Reha Zentrum, Heiligenschwendi

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thomas Radtke, PD, Dr phil

Organizational Affiliation

University of Zurich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Berner Reha Zentrum

City

Heiligenschwendi

State/Province

Bern

ZIP/Postal Code

3625

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28254766

Citation

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.

Results Reference

background

PubMed Identifier

24620992

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.

Results Reference

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PubMed Identifier

28621019

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.

Results Reference

background

PubMed Identifier

22743675

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.

Results Reference

background

PubMed Identifier

20522571

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.

Results Reference

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Impact of Chair Seat Height on the 1-Minute Sit to Stand Test Performance in Chronic Obstructive Pulmonary Disease

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