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

19. februar 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Nyresykdom

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

Kontakter og plasseringer

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

Studiesteder

Storbritannia
- Warwickshire
  - Coventry, Warwickshire, Storbritannia, CV1 3LN
    - UHCW

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

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

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Gruppe / Kohort

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.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

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

Sponsor

Coventry University

Etterforskere

Studieleder: Dr Elizabeth Elizabeth, Coventry University
Hovedetterforsker: Prof Derek Renshaw, Coventry University
Hovedetterforsker: Prof Alfonso Jimenez, Coventry University
Hovedetterforsker: Prof Nithya Krishnan, Coventry University

Publikasjoner og nyttige lenker

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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)

13. juni 2017

Primær fullføring (Faktiske)

31. januar 2019

Studiet fullført (Faktiske)

23. september 2019

Datoer for studieregistrering

Først innsendt

18. februar 2017

Først innsendt som oppfylte QC-kriteriene

21. februar 2017

Først lagt ut (Faktiske)

27. februar 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. februar 2020

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Acute Exercise Response, Renal

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