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

5 mars 2017 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

12

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Illinois
      • Urbana, Illinois, Förenta staterna, 61801
        • University of Illinois at Urbana-Champaign

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Standard Hemodialysis
Participants will be monitored during their normal hemodialysis treatment with no intervention administered
Procedur: Hemodialysis treatment
Participants will receive a standard hemodialysis treatment during the study period
Experimentell: 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
Procedur: Hemodialysis treatment
Participants will receive a standard hemodialysis treatment during the study period
Beteende: 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
Experimentell: 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
Procedur: Hemodialysis treatment
Participants will receive a standard hemodialysis treatment during the study period
Beteende: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Serial change in brachial blood pressure (mmHg) from start to end of a dialysis treatment
Tidsram: 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
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in total peripheral resistance estimated by peripheral blood pressure via a finger plethysmography and cardiac output via thoracic impedance (Task Force Monitor)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Illinois at Urbana-Champaign

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2016

Primärt slutförande (Faktisk)

1 december 2016

Avslutad studie (Faktisk)

1 februari 2017

Studieregistreringsdatum

Först inskickad

27 februari 2016

Först inskickad som uppfyllde QC-kriterierna

26 april 2016

Första postat (Uppskatta)

28 april 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 mars 2017

Senast verifierad

1 mars 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 15691

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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