Acute Physiological Response to Exercise in End Stage Renal Disease

NCT ID: NCT03064555

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-13

Study Completion Date

2019-09-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.


* 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


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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Coventry University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mr Scott McGuire

Clinical Exercise Physiologist (PhD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dr Elizabeth Elizabeth

Role: STUDY_DIRECTOR

Coventry University

Prof Derek Renshaw

Role: PRINCIPAL_INVESTIGATOR

Coventry University

Prof Alfonso Jimenez

Role: PRINCIPAL_INVESTIGATOR

Coventry University

Prof Nithya Krishnan

Role: PRINCIPAL_INVESTIGATOR

Coventry University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UHCW

Coventry, Warwickshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.

Reference Type BACKGROUND
PMID: 20585013 (View on PubMed)

Gould DW, Graham-Brown MP, Watson EL, Viana JL, Smith AC. Physiological benefits of exercise in pre-dialysis chronic kidney disease. Nephrology (Carlton). 2014 Sep;19(9):519-27. doi: 10.1111/nep.12285.

Reference Type BACKGROUND
PMID: 24899042 (View on PubMed)

Kettner A, Goldberg A, Hagberg J, Delmez J, Harter H. Cardiovascular and metabolic responses to submaximal exercise in hemodialysis patients. Kidney Int. 1984 Jul;26(1):66-71. doi: 10.1038/ki.1984.135.

Reference Type BACKGROUND
PMID: 6482181 (View on PubMed)

Nelson A, Otto J, Whittle J, Stephens RC, Martin DS, Prowle JR, Ackland GL. Subclinical cardiopulmonary dysfunction in stage 3 chronic kidney disease. Open Heart. 2016 Feb 24;3(1):e000370. doi: 10.1136/openhrt-2015-000370. eCollection 2016.

Reference Type BACKGROUND
PMID: 27127638 (View on PubMed)

Viana JL, Kosmadakis GC, Watson EL, Bevington A, Feehally J, Bishop NC, Smith AC. Evidence for anti-inflammatory effects of exercise in CKD. J Am Soc Nephrol. 2014 Sep;25(9):2121-30. doi: 10.1681/ASN.2013070702. Epub 2014 Apr 3.

Reference Type BACKGROUND
PMID: 24700875 (View on PubMed)

Peres A, Perotto DL, Dorneles GP, Fuhro MI, Monteiro MB. Effects of intradialytic exercise on systemic cytokine in patients with chronic kidney disease. Ren Fail. 2015 Aug 14:1-5. Online ahead of print.

Reference Type BACKGROUND
PMID: 26275117 (View on PubMed)

Cibulka R, Racek J. Metabolic disorders in patients with chronic kidney failure. Physiol Res. 2007;56(6):697-705. doi: 10.33549/physiolres.931128. Epub 2007 Feb 8.

Reference Type BACKGROUND
PMID: 17298212 (View on PubMed)

Chapter 1: Introduction and definition of CKD-MBD and the development of the guideline statements. Kidney Int. 2009 Aug;76113:S3-8. doi: 10.1038/ki.2009.189. No abstract available.

Reference Type RESULT
PMID: 26746396 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Acute Exercise Response, Renal

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Safe Kidney Care Cohort Study
NCT01407367 COMPLETED
Handgrip Exercise Training and CKD
NCT07094906 RECRUITING NA