NCT01912417

Brief Summary

The aim of this study is to evaluate the effect of aerobic exercise during dialysis on the hemodialysis efficacy in the removal of small molecules measured by continues spend sampling of dialysate (liquid metabolites produced by the body which is disposed) technique.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

1.5 years

First QC Date

July 26, 2013

Last Update Submit

September 4, 2013

Conditions

Keywords

HEMODIALYSISKidney Failure, ChronicAEROBIC EXERCISE

Outcome Measures

Primary Outcomes (1)

  • The main outcome was the dialysate concentrations of urea, creatinine, potassium and phosphate.

    The dialysate is collected by continuous spent sampling of dialysate (CSSD). For the CSSD technique, spent dialysate was continuously sampled by a reversed automatic infusion pump (Lifemed®) at a rate of 10 mL/hour. The dialysate concentrations of urea, creatinine, potassium and phosphate are measured in the sample recipient and the total masses removed are calculated by multiplying the dialysate concentration by the estimated total dialysate volume.

    three months

Study Arms (2)

Hemodialysis session with exercise

EXPERIMENTAL

Patients were included in a randomly crossover study design such that each patient received one HD session with exercise (intervention) and the next session without exercise (control), alternating for six consecutive HD sessions.

Other: Aerobic exercise with cycle ergometer during hemodialysis

hemodialysis session without exercise

NO INTERVENTION

Each patient received one hemodialysis session without exercise

Interventions

Participants underwent hemodialysis trained on an cycle ergometer. The training is performed in the first 2 hours of hemodialysis, with a total exercise time of 60 minutes. Each exercise period of 20 minutes was separated by 10 minutes of rest. The patients are advised to work with a level of perceived exertion of 'somewhat strong' (13-14 of Borg scale). For safety, heart rate and blood pressure were monitored throughout the session. The training is terminated if the patients exceeded 80% of their maximum heart rate (MHR = 220 - age in years), blood pressure parameters are exceeded (above 200/110 or below 110/50mmHg) or the patient had chest pain, severe dyspnea, wheezing, leg cramps, confusion, visual symptoms, pallor or cyanosis.

Hemodialysis session with exercise

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Francisco de Paula

Pelotas, Rio Grande do Sul, 96020-220, Brazil

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

July 26, 2013

First Posted

July 31, 2013

Study Start

August 1, 2010

Primary Completion

February 1, 2012

Study Completion

January 1, 2014

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations