NCT04579055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

October 1, 2020

Last Update Submit

July 20, 2021

Conditions

Keywords

1-minute Sit to Stand Testchair seat height

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sit to stand power index

    During pulmonary rehabilitation, approximately 14 days

Other Outcomes (6)

  • Oxygen saturation

    During pulmonary rehabilitation, approximately 14 days

  • Heart rate

    During pulmonary rehabilitation, approximately 14 days

  • Ratings of perceived exertion

    During pulmonary rehabilitation, approximately 14 days

  • +3 more other outcomes

Study Arms (2)

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.

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.

Other: 1-min STS test: standardized

Interventions

Individually adjusted chair seat height of 90° knee joint flexion

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

Standardized chair seat height of 46 cm

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosed COPD according to a forced expiratory volume in 1s (FEV1) / forced vital capacity (FVC) ratio below the lower limit of normal

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berner Reha Zentrum

Heiligenschwendi, Canton of Bern, 3625, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 28254766BACKGROUND
  • 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.

    PMID: 24620992BACKGROUND
  • 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.

    PMID: 28621019BACKGROUND
  • 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.

    PMID: 22743675BACKGROUND
  • 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.

    PMID: 20522571BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Riegler, MSc

    Berner Reha Zentrum, Heiligenschwendi

    PRINCIPAL INVESTIGATOR
  • Thomas Radtke, PD, Dr phil

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 8, 2020

Study Start

September 16, 2020

Primary Completion

March 25, 2021

Study Completion

March 30, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations