Counseling During Pulmonary Rehabilitation

NCT ID: NCT02455206

Last Updated: 2021-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-02-29

Brief Summary

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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

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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.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care

outpatient pulmonary Rehabilitation program

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Counseling

outpatient pulmonary Rehabilitation program plus physical activity counseling

Group Type EXPERIMENTAL

physical activity counseling

Intervention Type BEHAVIORAL

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

Interventions

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physical activity counseling

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

Intervention Type BEHAVIORAL

Usual care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Winterthur KSW

OTHER

Sponsor Role collaborator

Schweizer Lungenliga

UNKNOWN

Sponsor Role collaborator

Zurich University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Anne-Kathrin Rausch

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Hess, Dr med

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Winterthur KSW

Locations

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Kantonsspital

Winterthur, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 34641819 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34421298 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28818057 (View on PubMed)

Other Identifiers

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KEK-ZH-Nr. 2015-0179

Identifier Type: -

Identifier Source: org_study_id

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