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Validation of the 1-minute Sit-to-stand Test in Patients With COPD (STAND-UP)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
1-minute sit-to-stand test
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

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

Inclusion Criteria:

  • COPD diagnosis according to GOLD criteria; post bronchodilator FEV1/FVC<70%
  • Male and female patients ≥40 years of age
  • Able to do at least 5 repetitions in the 1-min STS test at baseline assessment
  • Written informed consent by the participant

Exclusion Criteria:

  • Lower limb joint surgery in the preceding 3 months
  • Too unstable medically to perform exercise tests
  • Predominant neurological or musculoskeletal limitation to walking
  • Cognitive reading impairment and/or difficulties managing the eDiary and step-counter

Sites / Locations

  • University of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Pulmonary Rehabilitation Patients

Acute Care Hospital Patients

Arm Description

Validation of the 1-minute sit-to-stand test; for participants who consent including a extended daily assessment period of physical activity and patient-reported symptoms of exacerbations: Male and female COPD inpatients (≥40 years of age) from two pulmonary rehabilitation clinics (Klinik Barmelweid and Zürcher Höhenklinik Wald)

Validation of the 1-minute sit-to-stand test, including daily assessment of physical activity and patient-reported symptoms of exacerbations: Male and female COPD inpatients from two acute care hospitals (≥40 years of age; Stadtspital Waid and Spital Uster)

Outcomes

Primary Outcome Measures

1-minute sit-to-stand test
Number of repetitions performed in the 1-minute sit-to-stand test

Secondary Outcome Measures

5-repetition sit-to-stand test
Time taken to perform 5 sit-to-stand repetitions
6-minute walk test
Distance walked in 6 minutes
Quadriceps maximal voluntary contraction force
Chronic Respiratory Questionnaire
Hospital Anxiety and Depression Scale
COPD Assessment Test
Baseline Dyspnoea & Transition Dyspnoea Index
Feeling Thermometer
Oxygen consumption (VO2)
Carbon dioxide production (VCO2)
Respiratory exchange ratio (RER)
Minute ventilation (VE)
Heart Rate
Blood oxygen saturation
Symptoms of exacerbations
The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)
Physical activity
As measured by a pedometer
Localisation
As measured by GPS information

Full Information

First Posted
April 29, 2015
Last Updated
October 24, 2016
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02441725
Brief Title
Validation of the 1-minute Sit-to-stand Test in Patients With COPD
Acronym
STAND-UP
Official Title
1-minute Sit-to-stand Test: A Multicentre Validation Study of a Simple Exercise Capacity Test in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a study to provide an in-depth validation of the 1-minute sit-to-stand test as a measure of exercise capacity in patients with chronic obstructive pulmonary disease (COPD). Patients will perform the 1-minute sit-to-stand test and other validated exercise tests and questionnaires.
Detailed Description
Exercise capacity is a strong predictor for mortality, exacerbations and health-related quality of life (HRQL) in patients with chronic obstructive pulmonary disease (COPD). The 1-minute sit-to-stand test (1-min STS test) is a promising exercise capacity test that is simple to conduct and requires few resources. This study will provide an in-depth validation of the 1-min STS test, specifically evaluating the tests reliability, validity, responsiveness to change and minimal clinically important difference. The study will also assess the predictive properties of the 1-min STS test with regards to detecting exacerbations, as well as identify patterns of physical activity and patient-reported symptoms of exacerbations.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary Rehabilitation Patients
Arm Type
Other
Arm Description
Validation of the 1-minute sit-to-stand test; for participants who consent including a extended daily assessment period of physical activity and patient-reported symptoms of exacerbations: Male and female COPD inpatients (≥40 years of age) from two pulmonary rehabilitation clinics (Klinik Barmelweid and Zürcher Höhenklinik Wald)
Arm Title
Acute Care Hospital Patients
Arm Type
Other
Arm Description
Validation of the 1-minute sit-to-stand test, including daily assessment of physical activity and patient-reported symptoms of exacerbations: Male and female COPD inpatients from two acute care hospitals (≥40 years of age; Stadtspital Waid and Spital Uster)
Intervention Type
Other
Intervention Name(s)
1-minute sit-to-stand test
Intervention Description
Validation of the 1-minute sit-to-stand test in a COPD patient population
Primary Outcome Measure Information:
Title
1-minute sit-to-stand test
Description
Number of repetitions performed in the 1-minute sit-to-stand test
Time Frame
Change from baseline after pulmonary rehabilitation programme
Secondary Outcome Measure Information:
Title
5-repetition sit-to-stand test
Description
Time taken to perform 5 sit-to-stand repetitions
Time Frame
Change from baseline after pulmonary rehabilitation programme
Title
6-minute walk test
Description
Distance walked in 6 minutes
Time Frame
Change from baseline after pulmonary rehabilitation programme
Title
Quadriceps maximal voluntary contraction force
Time Frame
Change from baseline after pulmonary rehabilitation programme
Title
Chronic Respiratory Questionnaire
Time Frame
Change from baseline after pulmonary rehabilitation programme
Title
Hospital Anxiety and Depression Scale
Time Frame
Change from baseline after pulmonary rehabilitation programme
Title
COPD Assessment Test
Time Frame
Change from Baseline after pulmonary rehabilitation programme
Title
Baseline Dyspnoea & Transition Dyspnoea Index
Time Frame
Change from baseline after pulmonary rehabilitation programme
Title
Feeling Thermometer
Time Frame
Change from baseline after pulmonary rehabilitation programme
Title
Oxygen consumption (VO2)
Time Frame
Change from baseline (pre-exercise test) during and after test
Title
Carbon dioxide production (VCO2)
Time Frame
Change from baseline (pre-exercise test) during and after test
Title
Respiratory exchange ratio (RER)
Time Frame
Change from baseline (pre-exercise test) during and after test
Title
Minute ventilation (VE)
Time Frame
Change from baseline (pre-exercise test) during and after test
Title
Heart Rate
Time Frame
Change from baseline (pre-exercise test) during and after test
Title
Blood oxygen saturation
Time Frame
Change from baseline (pre-exercise test) during and after test
Title
Symptoms of exacerbations
Description
The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)
Time Frame
Daily course over 3 months
Title
Physical activity
Description
As measured by a pedometer
Time Frame
Daily course over 3 months
Title
Localisation
Description
As measured by GPS information
Time Frame
Daily course over 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD diagnosis according to GOLD criteria; post bronchodilator FEV1/FVC<70% Male and female patients ≥40 years of age Able to do at least 5 repetitions in the 1-min STS test at baseline assessment Written informed consent by the participant Exclusion Criteria: Lower limb joint surgery in the preceding 3 months Too unstable medically to perform exercise tests Predominant neurological or musculoskeletal limitation to walking Cognitive reading impairment and/or difficulties managing the eDiary and step-counter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anja Frei, pHd
Organizational Affiliation
University of Zurich, Epidemiology, Biostatistics and Prevention Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Zurich
City
Zurich
ZIP/Postal Code
8001
Country
Switzerland

12. IPD Sharing Statement

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Validation of the 1-minute Sit-to-stand Test in Patients With COPD

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