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Akutt kardiorespiratorisk respons på blodstrømsbegrenset versus tradisjonelle treningsregimer (CaRe BFR) (CaRe-BFR)

3. juli 2026 oppdatert av: Christian Clarenbach, University of Zurich

Akutt kardiorespiratorisk respons på blodstrømsbegrenset versus tradisjonelle treningstreningsregimer (CaRe BFR):4 randomiserte crossover-studier

Etterforskerne antar at BFR-treningsregimer resulterer i et annet akutt kardiorespiratorisk responsmønster sammenlignet med tradisjonelle treningsregimer. Videre antar etterforskerne at disse mønstrene er forskjellige mellom friske deltakere og deltakere med KOLS.

Når det gjelder sekundært mål, antar etterforskerne at BFR resulterer i lavere blodtrykksrespons sammenlignet med tradisjonell treningstrening hos både friske og KOLS-deltakere.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Etterforskerne gjennomfører et monosentrisk prosjekt med 4 randomiserte crossover-studier.

CaRe-BFR Sunn og KOLS:

Styrketrening utføres bilateralt på en Leg Press-maskin (Leg Press VR2, Cybex International Inc. Medway, MA, USA) ved bruk av tre sett-metodikken, som har vist seg å være mest effektiv for å øke muskelstyrken.16 Hvert sett utføres til muskelsvikt, som bør nås innen 8-12 repetisjoner. Treningsrytmen er satt til 1-0-1-0 (dvs. ett sekund for den konsentriske fasen, ingen pause, ett sekund for den eksentriske fasen, ingen pause) og eksternt tempoet av en metronom. Treningsbelastningen er 80 % av 1RM. Hvile mellom settene er 1 minutt og deltakerne gjenstår

Styrketrening BFR utføres bilateralt på en Leg Press-maskin (Leg Press VR2, Cybex International Inc. Medway, MA, USA) i samsvar med evidensbaserte retningslinjer for bruk for å anvende den mest effektive metodikken for å forbedre muskelstyrken.17 Øvelsen består av totalt 75 repetisjoner i løpet av 4 sett. Treningsrytmen er satt til 1-0-1-0 (dvs. ett sekund for den konsentriske fasen, ingen pause, ett sekund for den eksentriske fasen, ingen pause) og eksternt tempoet av en metronom. Sett 1 dekker 30 repetisjoner, og de påfølgende settene 15 repetisjoner hver. Treningsbelastningen er 30 % av 1RM. Mansjetter monteres bilateralt på den mest proksimale delen av låret og blåses opp til 70 % av den individuelle AOP. Hvile mellom settene er 1 minutt og deltakerne blir sittende med mansjettene oppblåste.

-Utholdenhet utføres bilateralt på et stasjonært sykkelergometer (kardiomed 521, proxomed Medizintechnik GmbH, Alzenau, Tyskland) i en intervallsetting med belastningsfaser på 1 sett med 3 intervaller som varer i 2 minutter hver; treningsbelastning er 65 % av peak work rate (PWR). Mellom intervallene er pausene standardisert til 1 minutt. Før treningskampen utføres oppvarmingssykling ved 30 % PWR i 5 minutter for å nå en stabil tilstand i HR og RER.

Endurance BFR utføres bilateralt på et stasjonært sykkelergometer (kardiomed 521, proxomed Medizintechnik GmbH, Alzenau, Tyskland) i en intervallinnstilling med belastningsfaser på 1 sett med 3 intervaller som varer i 2 minutter og 18 sekunder hver (tilsvarer det totale arbeidet utført i NO); treningsbelastningen er 50 % av PWR mens blodstrømmen er begrenset til 50 % av AOP. Mellom intervallene er pausene standardisert til 1 minutt (mansjetten oppblåst). Før treningskampen utføres oppvarmingssykling (uten BFR) ved 30 % PWR i 5 minutter for å nå en stabil tilstand i HR og RER.

Målinger:

Under trening samler etterforskerne inn pust-for-pust-data (Ergostik, Geratherm Respiratory GmbH, Bad Kissingen, Tyskland). I tillegg samles kontinuerlig SpO2- og HR-data via en øreflippprobe og BP-respons umiddelbart etter treningssett.

Studietype

Intervensjonell

Registrering (Antatt)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Sveits
    • Canton of Zurich
      • Zurich, Canton of Zurich, Sveits, 8091
        • Rekruttering
        • University Hospital Zurich
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Beskrivelse

Inkludering og ekskludering for de friske deltakerne er definert av følgende kriterier.

Inklusjonskriterier:

  • Alder ≥ 18 år
  • Klinisk sunn

Ekskluderingskriterier:

  • Fysisk eller intellektuell svekkelse som utelukker informert samtykke eller protokolloverholdelse
  • Ikke-tysktalende (ulukker informert samtykke)
  • Smerter under trening uansett opprinnelse
  • Svangerskap
  • Anamnese med tromboembolisk hendelse i underekstremiteten
  • Systolisk blodtrykk i hvile <100 mmHg

Inkludering og eksklusjon for KOLS-deltakerne er definert av følgende kriterier.

Inklusjonskriterier:

  • Alder ≥ 18 år
  • Diagnostisert KOLS i henhold til GULL-retningslinjer12

Ekskluderingskriterier:

  • Fysisk eller intellektuell svekkelse som utelukker informert samtykke eller protokolloverholdelse
  • Ikke-tysktalende (ulukker informert samtykke)
  • Akutt eller nylig (innen de siste 6 ukene) forverring av KOLS
  • Smerter under trening uansett opprinnelse
  • Svangerskap
  • Anamnese med tromboembolisk hendelse i underekstremiteten
  • Systolisk blodtrykk i hvile <100 mmHg

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Eksperimentell: 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.
Annen: 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).
Eksperimentell: 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)
Annen: 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.
Eksperimentell: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Zurich

Etterforskere

  • Hovedetterforsker: Christian Clarenbach, Dr. med, University of Zurich

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. mai 2022

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

3. desember 2021

Først innsendt som oppfylte QC-kriteriene

17. desember 2021

Først lagt ut (Faktiske)

20. desember 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2021-02038

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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