We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04579055
Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : July 21, 2021
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Thomas Riegler, Berner Reha Zentrum AG

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.

Condition or disease Intervention/treatment Phase
COPD Chronic Obstructive Pulmonary Disease Other: 1-min STS test: adjusted Other: 1-min STS test: standardized Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
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
Actual Study Start Date : September 16, 2020
Actual Primary Completion Date : March 25, 2021
Actual Study Completion Date : March 30, 2021


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.
Other: 1-min STS test: adjusted
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.
Other: 1-min STS test: standardized
Standardized chair seat height of 46 cm




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.)


Other Outcome Measures:
  1. Oxygen saturation [ Time Frame: During pulmonary rehabilitation, approximately 14 days ]
    Difference in oxygen saturation profiles between the two experimental conditions

  2. Heart rate [ Time Frame: During pulmonary rehabilitation, approximately 14 days ]
    Difference in heart rate profiles between the two experimental conditions

  3. 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)

  4. 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)

  5. 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

  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579055


Locations
Layout table for location information
Switzerland
Berner Reha Zentrum
Heiligenschwendi, Bern, Switzerland, 3625
Sponsors and Collaborators
Thomas Riegler
University of Zurich
Investigators
Layout table for investigator information
Principal Investigator: Thomas Riegler, MSc Berner Reha Zentrum, Heiligenschwendi
Principal Investigator: Thomas Radtke, PD, Dr phil University of Zurich
Publications:

Layout table for additonal information
Responsible Party: Thomas Riegler, Principal Investigator, Berner Reha Zentrum AG
ClinicalTrials.gov Identifier: NCT04579055    
Other Study ID Numbers: 2020-01677
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Riegler, Berner Reha Zentrum AG:
1-minute Sit to Stand Test
chair seat height
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases