NCT05163600

Brief Summary

The investigators hypothesize that BFR exercise regimens result in a different acute cardiorespiratory response pattern compared to traditional exercise regimens. Furthermore, the investigators hypothesize that these patterns differ between healthy participants and participants with COPD. Regarding secondary objective, the investigators hypothesize that BFR results in lower blood pressure responses compared to traditional exercise training in both healthy and COPD participants.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

3.6 years

First QC Date

December 3, 2021

Last Update Submit

May 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Within-subject difference in maximal minute ventilation (VE) between BFR and traditional exercise regimens

    investigators will examine VE during strength training and endurance training with and without BFR. Each training sessions will last approximately 20 minutes including baseline CPET. There will be no measurements between the trainings. There will be a minimum wait of 48 hours (wash out timne) until training 2 is performed.

    basline (CPET) 20 min, V1 Training (endurance or strengthwith) with or without BFR 20 min; V2 Training (endurance or strengthwith) with or without BFR 20 min

Study Arms (2)

COPD

EXPERIMENTAL

Diagnosed COPD according to GOLD-guidelines

Other: Blod flow restriction training

Healthy

EXPERIMENTAL

Age ≥ 18 years Clinically healthy

Other: Blod flow restriction training

Interventions

includes one strength and one endurance training

COPDHealthy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Clinically healthy

You may not qualify if:

  • Physical or intellectual impairment precluding informed consent or protocol adherence
  • Non-German speaking (precluding informed consent)
  • Pain during exercise of any origin
  • Pregnancy
  • History of thromboembolic event in the lower extremity
  • Resting systolic blood pressure \<100 mmHg
  • Age ≥ 18 years
  • Diagnosed COPD according to GOLD-guidelines12
  • 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
  • Pain during exercise of any origin
  • Pregnancy
  • History of thromboembolic event in the lower extremity
  • Resting systolic blood pressure \<100 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zürich

Zurich, 8091, Switzerland

RECRUITING

Related Publications (1)

  • Kuhn M, Clarenbach CF, Klay A, Kohler M, Mayer LC, Luchinger M, Andrist B, Radtke T, Haile SR, Sievi NA, Kohlbrenner D. Exploring immediate cardiorespiratory responses: low-intensity blood flow restricted cycling vs. moderate-intensity traditional exercise in a randomized crossover trial. BMC Sports Sci Med Rehabil. 2024 Aug 15;16(1):172. doi: 10.1186/s13102-024-00951-0.

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

  • Christian Clarenbach, Dr. med

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christan Clarenbach, Dr. med

CONTACT

Manuel Kuhn, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: monocenter
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med Head of Pneumology

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 20, 2021

Study Start

May 20, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations