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SNCTP000001426 | NCT02455206

Aktiv im Alltag trotz chronisch obstruktiver Lungenerkrankung

Data source: BASEC (Imported from 20.10.2020), WHO (Imported from 18.10.2020)
Changed: 02.11.2018
Disease category: Respiratory diseases (non cancer)

Brief description of trial (Data source: BASEC)

Das übergeordnete Ziel dieser Studie ist es zu untersuchen ob individuell zugeschnittene Beratung im Rahmen der pulmonalen Rehabilitation einen Effekt auf die physische Aktivitiät im Alltag beim Patienten mit chronisch obstruktiver Lungenerkrankung hat.

Health conditions investigated (Data source: BASEC)

Chronic Obstructive Pulmonary Disease

Health conditions (Data source: WHO)

COPD

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Physical Activity Counselling

Interventions (Data source: WHO)

Behavioral: physical activity counseling;Behavioral: Usual care

Criteria for participation in trial (Data source: BASEC)

• Chronisch Obstruktive Lungenerkrankung (Stadium B-D)
• 40-90 Jahre
• deutschsprachig in Wort und Schrift
• Teilnahme an "Pneumofit" (Pulmonale Rehabilitation des Kantonspital Winterthur)
• Unterzeichnete Einverständniserklärung

Exclusion criteria (Data source: BASEC)

• schwere Nebenerkrankungen (z.B. Angina, Embolie, Pneumonie)
• psychische Erkrankungen, mentale oder physische Be-hinderung (Mini-Mental Score < 20)
• Schwerer arterieller Bluthochdruck in Ruhe (> 200mm Hg systolisch, >120mmHg diastolisch)
• Morphine Medikation

Inclusion/Exclusion Criteria (Data source: WHO)


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)

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02455206

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02455206

Further information on trial

Date trial registered

21.05.2015

Incorporation of the first participant

01.10.2015

Recruitment status

Recruiting

Academic title (Data source: WHO)

Effect of Counseling During Pulmonary Rehabilitation on Self-determined Motivation Towards Physical Activity in Patients With Chronic Obstructive Pulmonary Disease

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

number of steps per day

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Winterthur

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Rausch Anne-Kathrin
058 9346965
rauh@zhaw.ch

Contact for general information (Data source: WHO)

Thomas Hess, Dr med;Anne-Kathrin Rausch, MSc;Hess Thomas
Kantonsspital Winterthur KSW
0041 58 934 69 65;0522662332
rauh@zhaw.ch

Contact for scientific information (Data source: WHO)

Thomas Hess, Dr med;Anne-Kathrin Rausch, MSc;Hess Thomas
Kantonsspital Winterthur KSW
0041 58 934 69 65;0522662332
rauh@zhaw.ch

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Zurich University of Applied Sciences

Additional sponsors (Data source: WHO)

Kantonsspital Winterthur KSW;Schweizer Lungenliga

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Further trial identification numbers

Secondary ID (Data source: WHO)

KEK-ZH-Nr. 2015-0179