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Clinical Trials/NCT03579537
NCT03579537
Completed
Not Applicable

Effects of Exercise on Physical Fitness Among Hemodialysis Patients With Chronic Kidney Disease - as Part of the Project to Implement Exercise During Hemodialysis Reference 15/10

Universidad Politecnica de Madrid0 sites70 target enrollmentJuly 22, 2014
ConditionsHemolysis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemolysis
Sponsor
Universidad Politecnica de Madrid
Enrollment
70
Primary Endpoint
Change from baseline in Biochemical values, Protein KLOTHO at 3 month and 6 month
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Regular physical exercise was adapted to the situation of the patient with hemodialysis to help improve the quality of life of the patient

Detailed Description

It has been observed that programs that combine aerobic and resistance exercise can increase muscular strength and endurance, functional capacity and quality of life of patients in Hemodialysis. Aerobic exercise and muscular endurance during dialysis increase blood flow at the muscular level with an increase in capillary surface area, which dynamizes the flow of urea and toxins from the tissues to the vascular compartment, which could improve the effectiveness of dialysis In addition, moderate regular exercise can modulate the inflammatory response, which would be beneficial in patients with chronic kidney disease

Registry
clinicaltrials.gov
Start Date
July 22, 2014
End Date
October 30, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marcela Gonzalez Gross

Full Professor for Sport Nutrition and Exercise Physiology

Universidad Politecnica de Madrid

Eligibility Criteria

Inclusion Criteria

  • Famel and male between 55 - 85 year old. in hemodyalisis treatment

Exclusion Criteria

  • Younger than 55 years and older than 85 years.
  • Presenting myocardial infarction in the previous 6 weeks.
  • Unstable angina to exercise or at rest.
  • Recent cerebral vascular disease or with risk of recurrence.
  • Musculoskeletal, respiratory (COPD with frequent decompensation).
  • Hypertensive disorders, patients with peripheral vascular disease,
  • Active liver disease.
  • Osteoporosis diagnosed, in which the medical criterion is contraindicated physical exercise.
  • Solution of problems of the following circumstances:
  • Fraction of cardiac ejection \<of 45%, Hb \<of 10gr / dl.

Outcomes

Primary Outcomes

Change from baseline in Biochemical values, Protein KLOTHO at 3 month and 6 month

Time Frame: baseline, 3 month and 6 month

The measurement of Klotho in plasma (obtained from peripheral blood collected in tube with EDTA 3K anticoagulant) was performed by ELISA, with Well-wash 4 MK microplate washer (Thermo Electron Corporation) and Mutiskan EX microplate reader (Thermo Electron Corporation ), using the Human soluble α-Klotho Assay kit (Immuno-Biological Laboratories Co., Ltd, Japan). All samples were analyzed in duplicate following recommendations.

Secondary Outcomes

  • Change from baseline in Physical performance sit and stand at 6 month(Baseline and 6 month)
  • Change from baseline in Physical performance 6MWT at 6 month(Baseline and 6 month)
  • Change from baseline in Physical performance handgrip force at 6 month(Baseline and 6 month)
  • Change from baseline in Mental and health status (Beck Depression Inventory) at 6 month(Baseline and 6 month)
  • Change from baseline in Mental and health status (Health-related QoL <HRQoL> ) at 6 month(Baseline and 6 month)
  • Change from baseline in Mental and health status (level of anxiety) at 6 month(Baseline and 6 month)
  • Hemogram and Biochemical values , (hemoglobin, hematocrit and mean corpuscular volume )(Baseline)
  • Hemogram and Biochemical values (Iron, albumin, calcium and phosporus)(Baseline)
  • Change in Body Composition, Body mass index (BMI)(Baseline, 3 months and 6 ,months)
  • Change in Body Composition, Body Fat Index(Baseline, 3 months and 6 ,months)
  • Change in Body Composition, Fat Mass by body segment(Baseline, 3 months and 6 ,months)
  • Change in Body Composition, Total Muscle Mass(Baseline, 3 months and 6 ,months)
  • Hemogram and Biochemical values (Transferrin)(Baseline)
  • Hemogram and Biochemical values (Ferritin and PTH)(Baseline)
  • Hemogram and Biochemical values (The ions (Na +, K + and Cl-))(Baseline)
  • Hemogram and Biochemical values (The transferrin saturation index (IST))(Baseline)
  • Sociocultural aspects(Baseline)

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