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Den akutte kardiorespiratoriske reaktion på blodgennemstrømningsbegrænset versus traditionelle træningsregimer (CaRe BFR) (CaRe-BFR)

3. juli 2026 opdateret af: Christian Clarenbach, University of Zurich

Den akutte kardiorespiratoriske reaktion på blodgennemstrømningsbegrænset versus traditionelle træningsregimer (CaRe BFR): 4 randomiserede crossover-undersøgelser

Efterforskerne antager, at BFR træningsregimer resulterer i et andet akut kardiorespiratorisk responsmønster sammenlignet med traditionelle træningsregimer. Endvidere antager efterforskerne, at disse mønstre adskiller sig mellem raske deltagere og deltagere med KOL.

Med hensyn til sekundært mål antager efterforskerne, at BFR resulterer i lavere blodtryksreaktioner sammenlignet med traditionel træningstræning hos både raske og KOL-deltagere.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Efterforskerne udfører et monocentrisk projekt med 4 randomiserede krydsningsstudier.

CaRe-BFR Sund og KOL:

Styrketræning udføres bilateralt på en Leg Press-maskine (Leg Press VR2, Cybex International Inc. Medway, MA, USA) ved hjælp af de tre sæt-metoder, som har vist sig at være mest effektiv til at øge muskelstyrken.16 Hvert sæt udføres til muskelsvigt, som bør nås inden for 8-12 gentagelser. Træningsrytmen er indstillet til 1-0-1-0 (dvs. et sekund for den koncentriske fase, ingen pause, et sekund for den excentriske fase, ingen pause) og eksternt paceret af en metronom. Træningsbelastningen er 80% af 1RM. Hvile mellem sæt er 1 minut og deltagere forbliver

Styrketræning BFR udføres bilateralt på en Leg Press maskine (Leg Press VR2, Cybex International Inc. Medway, MA, USA) i overensstemmelse med evidensbaserede retningslinjer for anvendelse for at anvende den mest effektive metode til at øge muskelstyrken.17 Øvelsen består af i alt 75 gentagelser fordelt på 4 sæt. Træningsrytmen er indstillet til 1-0-1-0 (dvs. et sekund for den koncentriske fase, ingen pause, et sekund for den excentriske fase, ingen pause) og eksternt paceret af en metronom. Sæt 1 dækker 30 gentagelser, og de efterfølgende sæt 15 gentagelser hver. Træningsbelastningen er 30% af 1RM. Manchetter monteres bilateralt i den mest proksimale del af låret og pustes op til 70 % af den individuelle AOP. Hvile mellem sæt er 1 minut, og deltagerne bliver siddende med manchetterne oppustede.

-Udholdenhed udføres bilateralt på et stationært cykelergometer (kardiomed 521, proxomed Medizintechnik GmbH, Alzenau, Tyskland) i en intervalindstilling med belastningsfaser på 1 sæt med 3 intervaller af hver 2 minutter; træningsbelastning er 65 % af peak work rate (PWR). I mellem intervallerne er pauserne standardiseret til 1 minut. Før træningskampen udføres opvarmningscykling ved 30 % PWR i 5 minutter for at nå en stabil tilstand i HR og RER.

Endurance BFR udføres bilateralt på et stationært cykelergometer (kardiomed 521, proxomed Medizintechnik GmbH, Alzenau, Tyskland) i en intervalindstilling med belastningsfaser på 1 sæt med 3 intervaller af 2 minutter og 18 sekunder hver (svarende til det samlede arbejde udført i DA); træningsbelastningen er 50 % af PWR, mens lemmerblodstrømmen er begrænset til 50 % af AOP. I mellem intervallerne er pauserne standardiseret til 1 minut (manchetten oppustet). Før træningskampen udføres opvarmningscykling (uden BFR) ved 30 % PWR i 5 minutter for at nå en stabil tilstand i HR og RER.

Mål:

Under træning indsamler efterforskerne vejrtrækningsdata (Ergostik, Geratherm Respiratory GmbH, Bad Kissingen, Tyskland). Derudover indsamles kontinuerlige SpO2- og HR-data via en øreflip-sonde og BP-respons umiddelbart efter træningssæt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Schweiz
    • Canton of Zurich
      • Zurich, Canton of Zurich, Schweiz, 8091

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusion og eksklusion for de raske deltagere er defineret af følgende kriterier.

Inklusionskriterier:

  • Alder ≥ 18 år
  • Klinisk sund

Ekskluderingskriterier:

  • Fysisk eller intellektuel svækkelse, der udelukker informeret samtykke eller protokoloverholdelse
  • Ikke-tysktalende (udelukker informeret samtykke)
  • Smerter under træning af enhver oprindelse
  • Graviditet
  • Anamnese med tromboembolisk hændelse i underekstremiteten
  • Hvilesystolisk blodtryk <100 mmHg

Inklusion og eksklusion for KOL-deltagere er defineret af følgende kriterier.

Inklusionskriterier:

  • Alder ≥ 18 år
  • Diagnosticeret KOL efter GULD-vejledning12

Ekskluderingskriterier:

  • Fysisk eller intellektuel svækkelse, der udelukker informeret samtykke eller protokoloverholdelse
  • Ikke-tysktalende (udelukker informeret samtykke)
  • Akut eller nylig (inden for de sidste 6 uger) eksacerbation af KOL
  • Smerter under træning af enhver oprindelse
  • Graviditet
  • Anamnese med tromboembolisk hændelse i underekstremiteten
  • Hvilesystolisk blodtryk <100 mmHg

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Endurance Exercise - COPD and Healthy Participants (Fixed-Duration Protocol)

Both COPD patients and healthy participants will complete two endurance exercise conditions in a randomized, crossover design:

  • Blood Flow Restriction Cycling (BFR-CYC)
  • Non-BFR Control Cycling

BFR-CYC: Three intervals of 2 minutes at 50% PWR, separated by 1-minute recovery periods, with bilateral thigh cuffs inflated to 50% LOP during exercise intervals.

Control: Time- and structure-matched protocol (3 × 2 minutes) without blood flow restriction at 65% PWR, with identical recovery periods.
Andet: BFR-CYC 3x2min
BFR-CYC: Three intervals of 2 minutes at 50% PWR, separated by 1-minute recovery periods, with bilateral thigh cuffs inflated to 50% LOP during exercise intervals.
Eksperimentel: Resistance Exercise - COPD and Healthy Participants (BFR vs Control, Fixed Protocol)

Both COPD patients and healthy participants will complete two resistance exercise conditions in a randomized, crossover design:

  • Blood Flow Restriction Resistance Exercise (BFR-RE)
  • Non-BFR Control Resistance Exercise BFR-RE: Unilateral right-leg press at 40% of one-repetition maximum (1RM) with cuffs inflated to 80% LOP. Protocol: 4 sets (30-15-15-15 repetitions).

Control: Bilateral leg press at 40% 1RM, 3 sets of 15 repetitions, without blood flow restriction.
Andet: BFR Resistance 80% LOP
BFR-RE: Unilateral right-leg press at 40% of one-repetition maximum (1RM) with cuffs inflated to 80% LOP. Protocol: 4 sets (30-15-15-15 repetitions).
Eksperimentel: Endurance Exercise - COPD Participants (Exhaustive Protocol)

Patients with COPD will complete three cycling exercise conditions in a randomized, crossover design:

  • Blood Flow Restriction Cycling (BFR-CYC)
  • Continuous Cycling (CONT-CYC)
  • Interval Cycling (INT-CYC)
Andet: BFR-CYC 50% peak / 50% AOP (exhaustive)
BFR-CYC: Continuous cycling at 50% peak work rate (PWR) with bilateral thigh cuffs inflated to 50% limb occlusion pressure (LOP). A maximum duration of 30 minutes is applied as a safety limit.
Eksperimentel: Resistance Exercise - Healthy Participants (LOP Comparison Arm)

Healthy participants will complete two BFR resistance exercise conditions in a randomized, crossover design:

  • BFR at 40% LOP
  • BFR at 80% LOP Participants will perform unilateral right-leg press exercise at 40% 1RM using a standardized protocol of 4 sets (30-15-15-15 repetitions) with fixed rest intervals. The protocol will be completed as prescribed (not to volitional exhaustion) unless predefined safety criteria require early termination.
Andet: BFR REsistance 48% vs. 80% LOP
  • BFR at 40% LOP
  • BFR at 80% LOP All sessions will be conducted on a leg press device under standardized laboratory conditions. Pneumatic cuffs will be applied to the proximal thigh of the right leg.

Participants will perform unilateral right-leg press exercise at 40% 1RM using a standardized protocol of 4 sets (30-15-15-15 repetitions) with fixed rest intervals. The protocol will be completed as prescribed (not to volitional exhaustion) unless predefined safety criteria require early termination.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Endurance Exercise:(Fixed-Duration Protocol):
Tidsramme: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
Minute ventilation (VE) will be continuously assessed during cycling exercise across all conditions to evaluate ventilatory demand.
Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
Resistance Exercise - Healthy Participants (LOP Comparison Arm): Within-subject difference change in Maximal Voluntary Contraction (MVC)
Tidsramme: Pre-exercise and immediately post-exercise (within minutes after completion of the exercise protocol)
Maximal voluntary contraction (MVC) of the knee extensors will be assessed before and immediately after unilateral leg press exercise performed with blood flow restriction at 40% and 80% limb occlusion pressure (LOP). MVC will be measured using an isometric setup, and voluntary activation will be evaluated using the twitch interpolation technique with supramaximal electrical stimulation. The primary outcome is the change in MVC from pre- to post-exercise, reflecting exercise-induced neuromuscular fatigue.
Pre-exercise and immediately post-exercise (within minutes after completion of the exercise protocol)
Endurance Exercise - COPD Participants (Exhaustive Protocol): Within-subject difference in maximal minute ventilation (VE) between BFR and traditional exercise regimens
Tidsramme: Continuously during exercise, at end of exercise (peak value), and within 4 minutes post-exercise
Minute ventilation (VE) will be continuously assessed during cycling exercise across all conditions to evaluate ventilatory demand and response.
Continuously during exercise, at end of exercise (peak value), and within 4 minutes post-exercise
Resistance Exercise:(Healthy and COPD): Ventilatory Response (Ventilation, VE)
Tidsramme: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
Minute ventilation (VE) will be continuously assessed during cycling exercise across all conditions to evaluate ventilatory demand.
Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Resistance Exercise - Healthy Participants (LOP Comparison Arm): Muscle Oxygenation (NIRS)
Tidsramme: Continuously during exercise and immediately post-exercise
Muscle oxygenation of the knee extensors will be continuously assessed using near-infrared spectroscopy (NIRS) during unilateral leg press exercise performed with blood flow restriction at 40% and 80% limb occlusion pressure (LOP). Parameters such as tissue oxygen saturation will be analyzed to evaluate local muscular oxygenation responses.
Continuously during exercise and immediately post-exercise
Resistance Exercise - Healthy Participants (LOP Comparison Arm): Perceived Exertion / Dyspnea (Borg Scale)
Tidsramme: At baseline (pre-exercise), after each set, immediately post-exercise, and at 2 and 4 minutes post-exercise

Perceived exertion will be assessed using the Borg rating of perceived exertion (RPE) scale during cycling exercise.

Perceived breathlessness will be assessed using the Borg dyspnea scale during exercise.
At baseline (pre-exercise), after each set, immediately post-exercise, and at 2 and 4 minutes post-exercise
Endurance Exercise - COPD Participants (Exhaustive Protocol): Cardiorespiratory Response (Vo2 , VCO2)
Tidsramme: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise

Oxygen uptake (VO₂) will be continuously measured during cycling exercise performed under three conditions (BFR-CYC, CONT-CYC, INT-CYC) to symptom limitation. The primary outcome will be the peak VO₂ achieved at end of exercise, reflecting maximal cardiorespiratory response.

Carbon dioxide production (VCO₂) will be continuously measured during exercise to assess metabolic and ventilatory responses.
Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
Endurance Exercise - COPD Participants (Exhaustive Protocol):NIRS
Tidsramme: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
Muscle oxygenation will be assessed using near-infrared spectroscopy (NIRS) during cycling exercise to evaluate local muscular oxygenation under BFR and non-BFR conditions.
Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
Endurance Exercise - COPD Participants (Exhaustive Protocol): Blood Lactate Concentration
Tidsramme: At baseline (pre-exercise) at peak and 3 min wpost-exercise
Capillary blood lactate concentration will be measured to assess metabolic stress induced by the different exercise conditions.
At baseline (pre-exercise) at peak and 3 min wpost-exercise
Endurance Exercise - COPD Participants (Exhaustive Protocol): Perceived Exertion and Dyspnea (Borg Scale)
Tidsramme: At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise

Perceived exertion will be assessed using the Borg rating of perceived exertion (RPE) scale during cycling exercise.

Perceived breathlessness will be assessed using the Borg dyspnea scale during exercise.
At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise
Endurance Exercise - COPD Participants (Exhaustive Protocol): Exercise Tolerance (Time to Exhaustion)
Tidsramme: During exercise (recorded at end of exercise)
Exercise tolerance will be defined as the time from the start of exercise to symptom limitation (volitional exhaustion).
During exercise (recorded at end of exercise)
Endurance Exercise:(Fixed-Duration Protocol): Cardiorespiratory Response (Vo2 , VCO2)
Tidsramme: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
Carbon dioxide production (VCO₂) will be continuously measured during exercise to assess metabolic and ventilatory responses Oxygen uptake (VO₂) will be continuously measured during cycling exercise performed under two conditions. The primary outcome will be the peak VO₂ achieved at end of exercise, reflecting maximal cardiorespiratory response.
Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
Endurance Exercise:(Fixed-Duration Protocol): Borg Scale (Dyspnea/Perceived Exertion)
Tidsramme: At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise

Perceived exertion will be assessed using the Borg rating of perceived exertion (RPE) scale during cycling exercise.

Perceived breathlessness will be assessed using the Borg dyspnea scale during exercise.
At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise
Resistance Exercise:(Healthy and COPD): Cardiorespiratory Response
Tidsramme: Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise

Oxygen uptake (VO₂) will be continuously measured during cycling exercise performed under two conditions.

Carbon dioxide production (VCO₂) will be continuously measured during exercise to assess metabolic and ventilatory responses.
Continuously during exercise and at end of exercise, with recovery measurements obtained within 4 minutes post-exercise
Resistance Exercise:(Healthy and COPD): Dyspnea (Borg Scale/ Perceived Exertion )
Tidsramme: At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise

Perceived exertion will be assessed using the Borg rating of perceived exertion (RPE) scale during cycling exercise.

Perceived breathlessness will be assessed using the Borg dyspnea scale during exercise.
At baseline (pre-exercise), during exercise (at regular intervals), at end of exercise, and within 4 minutes post-exercise

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Zurich

Efterforskere

  • Ledende efterforsker: Christian Clarenbach, Dr. med, University of Zurich

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. maj 2022

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

3. december 2021

Først indsendt, der opfyldte QC-kriterier

17. december 2021

Først opslået (Faktiske)

20. december 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021-02038

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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