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Acute Physiological Response to Exercise in End Stage Renal Disease (PRECISE)

19. februar 2020 opdateret af: Mr Scott McGuire, Coventry University
Chronic kidney disease (CKD) affects between 5-10% of the world's population, equating to ~740 million people worldwide. End stage renal disease (ESRD) is the result of a progressive loss of kidney function where the patient requires dialysis to replace the typical functions of the kidney. The quality of life of these individuals can be poor as a result of various complications associated with CKD (e.g. heart disease, diabetes, muscle wastage, decreased fitness). In an attempt to combat reduced physical fitness, many studies have applied long term exercise programmes. However, the body's response to exercise in people with CKD is not well understood and a set of guidelines that informs safe and effective exercise prescription is lacking.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Chronic kidney disease (CKD) affects between 5-10% of the world's population, equating to ~740 million people worldwide. End stage renal disease (ESRD) is the result of a progressive loss of kidney function where the patient requires dialysis to replace the typical functions of the kidney. The quality of life (QOL) of these individuals is severely impaired as a result of various complications associated with CKD (e.g. heart disease, diabetes, muscle wastage, decreased fitness). In an attempt to combat this decrease in physical fitness, many studies have applied long term exercise interventions. However, the acute response to exercise in this population is not entirely understood and a comprehensive set of guidelines that informs safe and effective exercise prescription is lacking.

The use of exercise as a therapeutic intervention in ESRD has grown in popularity, and evidence provided by numerous long term studies indicates cardiopulmonary, metabolic and inflammatory system adaptations. Despite these positive findings, the specific mechanisms through which exercise benefits these patients have not yet been fully established. In addition, the extent to which 'normal' physiology is acutely altered by dialysis treatment, and the effect that aerobic exercise may have on this, is unknown.

In patients with ESRD, this study aims to characterise the acute physiological response to exercise under different conditions. In doing so, the study aims to inform the development of guidelines for safe and effective intra-dialytic exercise training.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

40

Kontakter og lokationer

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

Studiesteder

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants with end stage renal disease:

Patients will be recruited from the University Hospitals Coventry & Warwickshire hemodialysis unit identified by the research team and renal medical professionals.

Healthy participants:

Healthy participants will be recruited from Coventry University database of previous research participants. This group will comprise of 20 participants, age and weight matched to the patients with ESRD.

Beskrivelse

Participants with end stage renal disease

Inclusion criteria

  • On hemodialysis for at least 3 months.
  • 4 hours of dialysis 3 times per week.
  • Urea reduction rate of at least 65% during the three months before enrolment.
  • Age 18 years or older.
  • Able to complete the CPEX and CLE test.

Exclusion criteria

  • Clinically significant valvular insufficiency.
  • Clinically significant dysrhythmia.
  • Uncontrolled intra-dialytic blood pressure (systolic > 180, diastolic >95).
  • Excessive fluid accumulation between dialysis sessions (>3 liters).
  • Hemoglobin unstable (below 9.0 g/dL).
  • Ischemic cardiac event (<1 month).
  • Unable to exercise.
  • Morbidly obese (BMI > 40).
  • Clinically significant and still active inflammatory or malignant process.
  • Planned kidney transplant during the duration of study.

Healthy participants

Inclusion criteria

  • Age 18 years or older.
  • Able to complete the CPEX and CLE test.

Exclusion criteria

  • Significantly limiting disease or comorbidity which would prevent full participation in exercise testing or illicit an abnormal cardiorespiratory response to exercise.
  • Chronic kidney disease.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Participants with end stage renal disease

Cardiopulmonary exercise test

Cardiopulmonary exercise testing will be conducted on an electronically braked cycle ergometer using a ramped protocol with participants being required to pedal until exhaustion.

Constant load exercise test

Constant load exercise will be performed for 30 min on an electronically braked cycle ergometer whilst seated in a dialysis chair. Blood sampling and echocardiogram will be measured throughout.
Healthy participants

Cardiopulmonary exercise test

Cardiopulmonary exercise testing will be conducted on an electronically braked cycle ergometer using a ramped protocol with participants being required to pedal until exhaustion.

Constant load exercise test

Constant load exercise will be performed for 30 min on an electronically braked cycle ergometer whilst seated in a dialysis chair. Blood sampling and echocardiogram will be measured throughout.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gas analysis
Tidsramme: 2 months
Measurement of O2/CO2 kinetics.
2 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Echocardiogram
Tidsramme: 2 months
Measurement of regional wall motion abnormalities.
2 months
Echocardiogram
Tidsramme: 2 months
Measurement of ejection fraction.
2 months
Echocardiogram
Tidsramme: 2 months
Measurement of cardiac output.
2 months
Blood samples
Tidsramme: 2 months
Investigation of cardiac, inflammatory and hormonal response to exercise.
2 months
Non invasive cardiac output measurement (NICOM)
Tidsramme: 2 months
Measurement of cardiac output during exercise,
2 months

Samarbejdspartnere og efterforskere

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

Sponsor

Coventry University

Efterforskere

  • Studieleder: Dr Elizabeth Elizabeth, Coventry University
  • Ledende efterforsker: Prof Derek Renshaw, Coventry University
  • Ledende efterforsker: Prof Alfonso Jimenez, Coventry University
  • Ledende efterforsker: Prof Nithya Krishnan, Coventry University

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)

13. juni 2017

Primær færdiggørelse (Faktiske)

31. januar 2019

Studieafslutning (Faktiske)

23. september 2019

Datoer for studieregistrering

Først indsendt

18. februar 2017

Først indsendt, der opfyldte QC-kriterier

21. februar 2017

Først opslået (Faktiske)

27. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Acute Exercise Response, Renal

Plan for individuelle deltagerdata (IPD)

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