The Acute Cardiorespiratory Response to Blood-flow Restricted Versus Traditional Exercise Training Regimens (CaRe BFR)

NCT ID: NCT05163600

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2025-12-31

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.

Detailed Description

The investigatorscarry out a monocentric project with 4 randomized crossover studies.

CaRe-BFR Healthy and COPD:

Strength training is performed bilaterally on a Leg Press machine (Leg Press VR2, Cybex International Inc. Medway, MA, USA) using the three set methodology, which is proven to be most effective in enhancing muscle strength.16 Each set is performed to muscular failure, which should be reached within 8-12 repetitions. Training rhythm is set at 1-0-1-0 (i.e. one second for the concentric phase, no pause, one second for the eccentric phase, no pause) and externally paced by a metronome. The training load is 80% of the 1RM. Rest in between sets is 1 minute and participants remain

Strength training BFR is performed bilaterally on a Leg Press machine (Leg Press VR2, Cybex International Inc. Medway, MA, USA) in accordance with evidence-based application guidelines to apply the most effective methodology to enhance muscle strength.17 The exercise consists of a total of 75 repetitions during 4 sets. Training rhythm is set at 1-0-1-0 (i.e. one second for the concentric phase, no pause, one second for the eccentric phase, no pause) and externally paced by a metronome. Set 1 covers 30 repetitions, and the subsequent sets 15 repetitions each. The training load is 30% of the 1RM. Cuffs are mounted bilaterally at the most proximal part of the thigh and inflated to 70% of the individual AOP. Rest in between sets is 1 minute and participants remain seated with the cuffs inflated.

-Endurance is performed bilaterally on a stationary bicycle ergometer (kardiomed 521, proxomed Medizintechnik GmbH, Alzenau, Germany) in an interval setting with loading phases of 1 set with 3 intervals lasting for 2 minutes each; training load is 65% of the peak work rate (PWR). In between the intervals, breaks are standardised to 1 minute. Before the exercise bout, warm-up cycling at 30% PWR for 5 minutes is done to reach a steady state in HR and RER.

Endurance BFR is performed bilaterally on a stationary bicycle ergometer (kardiomed 521, proxomed Medizintechnik GmbH, Alzenau, Germany) in an interval setting with loading phases of 1 set with 3 intervals lasting for 2 minutes and 18 seconds each (matching the overall work performed in EN); training load is 50% of the PWR while limb blood flow is restricted to 50% of the AOP. In between the intervals, breaks are standardised to 1 minute (cuff inflated). Before the exercise bout, warm-up cycling (without BFR) at 30% PWR for 5 minutes is done to reach a steady state in HR and RER.

Measurements:

During exercise, the investigators collect breath-by-breath data (Ergostik, Geratherm Respiratory GmbH, Bad Kissingen, Germany). In addition, continuous SpO2 and HR data via an earlobe probe, and BP response immediately after exercise sets are collected

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COPD

Diagnosed COPD according to GOLD-guidelines

Group Type: EXPERIMENTAL

Blod flow restriction training

Intervention Type: OTHER

includes one strength and one endurance training

Healthy

Age ≥ 18 years Clinically healthy

Group Type: EXPERIMENTAL

Blod flow restriction training

Intervention Type: OTHER

includes one strength and one endurance training

Interventions

Blod flow restriction training

includes one strength and one endurance training

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Clinically healthy

• Age ≥ 18 years
• Diagnosed COPD according to GOLD-guidelines12

Exclusion Criteria

• 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

Inclusion and exclusion for the COPD participants are defined by the following 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
• Pain during exercise of any origin
• Pregnancy
• History of thromboembolic event in the lower extremity
• Resting systolic blood pressure <100 mmHg

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Christian Clarenbach

PD Dr. med Head of Pneumology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Clarenbach, Dr. med

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zürich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Christan Clarenbach, Dr. med

Role: CONTACT

Christian.clarenbach@usz.ch

044 255 22 21

Manuel Kuhn, PhD Student

Role: CONTACT

manuel.kuhn@usz.ch

0798526722

Facility Contacts

Manuel Kuhn, MSc

Role: primary

manuel.kuhn@usz.ch

0432532681

Alexandra Arvaji

Role: backup

alexandra.arvaji@usz.ch

0432530131

References

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.

Reference Type: DERIVED

PMID: 39148127 (View on PubMed)

Other Identifiers

2021-02038

Identifier Type: -

Identifier Source: org_study_id