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Acute Effects of Intradialytic Exercise on Cardiovascular Function in Hemodialysis Patients (ACE-HD)

5. mars 2017 oppdatert av: Kenneth Wilund, University of Illinois at Urbana-Champaign
The purpose of this study is to examine the effect of cycling at mild to moderate intensity during hemodialysis treatment on cardiovascular function in a crossover design.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Patients with kidney failure requiring hemodialysis (HD) treatment die at excessively high rates, despite advances in HD techniques and pharmacological therapies. This indicates additional therapeutic strategies are needed. Intradialytic exercise (IDEX, exercise during HD treatment) represents a low-cost, easy to administer treatment strategy that could potentially improve cardiovascular function, physical function and quality of life. However, nephrologists rarely counsel their patients to increase their physical activity levels or to exercise during HD treatment, in part due to a lack of understanding of IDEX knowledge.

Providing more robust evidence for the safety and effectiveness of IDEX, as well as evaluating the impact of exercising early vs late in the treatment, could help improve adoption of exercise training as a standard practice in HD clinics.

Therefore, investigators plan to examine the impact of IDEX and its timing during treatment (1st vs 3rd hour) on blood pressure and adverse symptoms in HD patients. The proposed study also includes various cardiovascular measures to allow deeper mechanistic understanding of cardiovascular physiology with IDEX. Such understanding will significantly advance the field and lead to improved therapeutic approaches, including exercise training, which may help mediate the deleterious effects of renal failure.

Studietype

Intervensjonell

Registrering (Faktiske)

12

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Illinois
      • Urbana, Illinois, Forente stater, 61801
        • University of Illinois at Urbana-Champaign

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 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Receiving hemodialysis treatment three times per week, on hemodialysis for greater than three months, receive medical clearance from a Nephrologists

Exclusion Criteria:

  • Patients with established contraindications to exercise including lower-limb amputation, advanced chronic obstructive pulmonary disease and decompensated chronic heart failure.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Standard Hemodialysis
Participants will be monitored during their normal hemodialysis treatment with no intervention administered
Fremgangsmåte: Hemodialysis treatment
Participants will receive a standard hemodialysis treatment during the study period
Eksperimentell: Hemodialysis with Exercise (1-st hr)
Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 1-st hour into treatment
Fremgangsmåte: Hemodialysis treatment
Participants will receive a standard hemodialysis treatment during the study period
Atferdsmessig: exercise
Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment
Eksperimentell: Hemodialysis with Exercise (3-rd hr)
Participants will be monitored during a normal dialysis treatment in which they cycle at mild to moderate intensity for 30 minutes during 3-rd hour into treatment
Fremgangsmåte: Hemodialysis treatment
Participants will receive a standard hemodialysis treatment during the study period
Atferdsmessig: exercise
Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment
Tidsramme: Every 15 minutes throughout each dialysis treatment (approximately 4 hours)
Systolic and diastolic blood pressure will be measured using an automated blood pressure cuff attached to the clinic dialysis machine
Every 15 minutes throughout each dialysis treatment (approximately 4 hours)
Changes in cardiac output (mL/min) measured by thoracic impedance technique
Tidsramme: Continous throughout a dialysis treatment (approximately 4 hours)
Cardiac output will be estimated continuously using thoracic impedance with electrodes placed around the chest.
Continous throughout a dialysis treatment (approximately 4 hours)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in total peripheral resistance estimated by peripheral blood pressure via a finger plethysmography and cardiac output via thoracic impedance (Task Force Monitor)
Tidsramme: Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week
A finger cuff will be placed around the non-dialyzing finger and will measure the change in peripheral blood pressure from successive beats continuously. Total peripheral resistance will be estimated using measured cardiac output and peripheral blood pressure.
Continuous throughout each dialysis treatment (approximately 4 hours) for three dialysis sessions that are separated by a week
Hypotensive event assessment measured by a symptom questionnaire
Tidsramme: Throughout and up to 5 hours after completion of a dialysis treatment
The presence of hypotensive-relating intradialytic symptoms including nausea, dizziness and cramping will be recorded.
Throughout and up to 5 hours after completion of a dialysis treatment

Samarbeidspartnere og etterforskere

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

Sponsor

University of Illinois at Urbana-Champaign

Etterforskere

  • Hovedetterforsker: Kenneth Wilund, PhD, University of Illinois at Urbana-Champaign

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

1. februar 2016

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

1. februar 2017

Datoer for studieregistrering

Først innsendt

27. februar 2016

Først innsendt som oppfylte QC-kriteriene

26. april 2016

Først lagt ut (Anslag)

28. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mars 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mars 2017

Sist bekreftet

1. mars 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 15691

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

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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