Clinical trial NCT02455206: Counseling During Pulmonary Rehabilitation
Official title: Effect of Counseling During Pulmonary Rehabilitation on Self-determined Motivation Towards Physical Activity in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Kantonsspital Winterthur KSW
name: Schweizer Lungenliga
First posted: 2015-05-27
Enrollment: 43
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Participants performed a 12 weeks outpatient pulmonary rehab (PR) according to guidelines. Participants allocated to intervention received PR plus physical activity (PA) counselling. PA counselling was performed using "motivational interviewing" techniques and was provided by two experiences physiotherapists independant to the rehab team. After PR and three months follow-up was evaluated if PA counselling during PR increases PA elvel (primary outcome: steps per day) in daily life.

Furthermore, individual, semi-structured interviews were performed in a subgroup of participants in order to gain more detailed information about barriers and enablers of participation in daily-life activities. Participants were invited to two interviews, one right after PR the other after 3 months follow up. A content analysis was performed.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: number of steps per day
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Thomas Hess, Dr med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.