NCT02441725

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.

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 Apr 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.1 years

First QC Date

April 29, 2015

Last Update Submit

October 24, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1-minute sit-to-stand test

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

    Change from baseline after pulmonary rehabilitation programme

Secondary Outcomes (17)

  • 5-repetition sit-to-stand test

    Change from baseline after pulmonary rehabilitation programme

  • 6-minute walk test

    Change from baseline after pulmonary rehabilitation programme

  • Quadriceps maximal voluntary contraction force

    Change from baseline after pulmonary rehabilitation programme

  • Chronic Respiratory Questionnaire

    Change from baseline after pulmonary rehabilitation programme

  • Hospital Anxiety and Depression Scale

    Change from baseline after pulmonary rehabilitation programme

  • +12 more secondary outcomes

Study Arms (2)

Pulmonary Rehabilitation Patients

OTHER

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)

Other: 1-minute sit-to-stand test

Acute Care Hospital Patients

OTHER

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)

Other: 1-minute sit-to-stand test

Interventions

Validation of the 1-minute sit-to-stand test in a COPD patient population

Acute Care Hospital PatientsPulmonary Rehabilitation Patients

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich

Zurich, 8001, Switzerland

Location

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

  • Anja Frei, pHd

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 12, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations