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SNCTP000003509 | NCT04151771 | BASEC2019-01641

Krafttraining mit geringem Gewicht unter Blutflussreduktion bei COPD

Data source: BASEC (Imported from 26.04.2024), WHO (Imported from 25.04.2024)
Changed: Dec 23, 2023, 5:02 PM
Disease category: Respiratory diseases (non cancer)

Brief description of trial (Data source: BASEC)

Diese Studie wird als randomisierte kontrollierte Pilotstudie durchgeführt, dies bedeutet, dass alle Teilnehmenden per Zufall einer Gruppe zur Durchführung des Trainings unter Blutflussreduktion oder einer Gruppe zur Durchführung des traditionellen Krafttrainings zugeteilt werden. Alle Teilnehmenden bleiben für 12 Wochen (die Dauer des ambulanten pulmonalen Rehabilitationsprogramms) in der Studie. Es werden insgesamt 30 Personen zur Teilnahme an dieser Studie eingeschlossen.

Health conditions investigated(Data source: BASEC)

Chronisch obstruktive Lungenerkrankung (COPD)

Health conditions (Data source: WHO)

COPD;Muscle Weakness

Rare disease (Data source: BASEC)

No

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

Krafttraining mit geringem Gewicht unter Blutflussreduktion (low-load blood flow restriction training)

Interventions (Data source: WHO)

Other: Low-load blood flow restriction training;Other: Usual outpatient pulmonary rehabilitation

Criteria for participation in trial (Data source: BASEC)

diagnostizierte COPD (unabhängig vom Schweregrad), Zuweisung zur ambulanten pulmonalen Rehabilitation am Universitätsspital Zürich, mindestens 40 Jahre alt

Exclusion criteria (Data source: BASEC)

pulmonale Rehabilitation in den letzten 3 Monaten, Exazerbation der COPD in den letzten 6 Wochen, Thrombose oder Polyneuropathie in den Beinen

Inclusion/Exclusion Criteria (Data source: WHO)

Gender: All
Maximum age: N/A
Minimum age: 40 Years

Inclusion Criteria:

- Diagnosed COPD according to GOLD-guidelines

- Assigned to outpatient pulmonary rehabilitation by the treating physician

Exclusion Criteria:

- Physical or intellectual impairment precluding informed consent or protocol adherence

- Non-German speaking (precluding informed consent)

- Acute or recent (within the last 6 weeks) exacerbation of COPD

- Attending a pulmonary rehabilitation program within the last 3 months

- Pregnant patients

- History of thromboembolic event in the lower extremity

- Diagnosis of polyneuropathy

- Resting systolic blood pressure <100 mmHg

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04151771

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04151771
Further information on trial

Date trial registered

Oct 31, 2019

Recruitment status

Completed

Academic title (Data source: WHO)

Low-load Blood Flow Restriction Training in COPD

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)

Knee extensor strength

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)

Zurich

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

PD Dr. med. Christian Clarenbach
+41 44 255 17 12
christian.clarenbach@usz.ch

Contact for general information (Data source: WHO)

Christian F Clarenbach, MD
+41 44 255 17 12
christian.clarenbach@usz.ch

Contact for scientific information (Data source: WHO)

Christian F Clarenbach, MD
+41 44 255 17 12
christian.clarenbach@usz.ch

Authorisation by the ethics committee (Data source: BASEC)

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

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

28.10.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2019-01641

Secondary ID (Data source: WHO)

SNCTP000003509
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