Clinical trial NCT03579537: Effects of Exercise on Physical Fitness Among Hemodialysis Patients With Chronic Kidney Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemolysis
Keywords: Hemodialysis
Klotho Protein
Excercise
Lifestyle condition
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
Collaborators: name: Universidad Europea de Madrid
name: Fundación Renal Iñigo Alvarez De Toledo
First posted: 2018-07-06
Enrollment: 70
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group who perform 3 first month just with normal treatment of hemodialysis and the next 3 month exercise intervention. (6 months in total)
Primary purpose: SUPPORTIVE_CARE

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

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.
* Problematic vascular access, both immature fistulas or with risk of extravasation and catheter dysfunctions of postural characteristics.

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