NCT02455206

Brief Summary

The purpose of this study is to investigate if a physical activity counseling program during pulmonary rehabilitation increases the physical activity level in daily life in patients with Chronic Obstructive Pulmonary Disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 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

First Submitted

Initial submission to the registry

May 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

4.3 years

First QC Date

May 21, 2015

Last Update Submit

April 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of steps per day

    6 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

outpatient pulmonary Rehabilitation program

Behavioral: Usual care

Counseling

EXPERIMENTAL

outpatient pulmonary Rehabilitation program plus physical activity counseling

Behavioral: physical activity counseling

Interventions

5 face-to-face sessions a 30 minutes during 12 weeks pulmonary rehabilitation program.

Counseling
Usual careBEHAVIORAL
Usual Care

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed COPD (GOLD stages B-D) according to GOLD-guidelines

You may not qualify if:

  • Mental or physical disability (mini-mental score \<20) precluding informed consent or compliance with the protocol
  • morphine medication
  • Primary diagnosis of heart failure
  • Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
  • Severe co-morbidity (acute coronary syndrome, unstable angina terminal renal failure, concomitant pulmonary embolism, very severe pneumonia: CURB65\>3)
  • Severe untreated arterial hypertension at rest (\> 200 mm Hg systolic, \> 120 mm Hg diastolic)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital

Winterthur, Switzerland

Location

Related Publications (3)

  • Rausch Osthoff AK, Beyer S, Gisi D, Rezek S, Schwank A, Meichtry A, Sievi NA, Hess T, Wirz M. Effect of counselling during pulmonary rehabilitation on self-determined motivation to be physically active for people with chronic obstructive pulmonary disease: a pragmatic RCT. BMC Pulm Med. 2021 Oct 12;21(1):317. doi: 10.1186/s12890-021-01685-2.

  • Scheermesser M, Reicherzer L, Beyer S, Gisi D, Rezek S, Hess T, Wirz M, Rausch Osthoff AK. The Influence of Pulmonary Rehabilitation and Counselling on Perceptions of Physical Activity in Individuals with COPD - A Qualitative Study. Int J Chron Obstruct Pulmon Dis. 2021 Aug 14;16:2337-2350. doi: 10.2147/COPD.S315130. eCollection 2021.

  • Rausch-Osthoff AK, Greco N, Schwank A, Beyer S, Gisi D, Scheermesser M, Meichtry A, Sievi N, Hess T, Wirz M. Effect of counselling during pulmonary rehabilitation on self-determined motivation towards physical activity in people with chronic obstructive pulmonary disease - protocol of a mixed methods study. BMC Pulm Med. 2017 Aug 17;17(1):115. doi: 10.1186/s12890-017-0457-8.

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 Hess, Dr med

    Kantonsspital Winterthur KSW

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

May 21, 2015

First Posted

May 27, 2015

Study Start

October 1, 2015

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

April 15, 2021

Record last verified: 2021-04

Locations