Effects of Exercise on Physical Fitness Among Hemodialysis Patients With Chronic Kidney Disease
- Conditions
- Hemolysis
- Interventions
- Other: Intradyalisis without exercise programeOther: Intradyalisis with exercise programe
- Registration Number
- NCT03579537
- Lead Sponsor
- Universidad Politecnica de Madrid
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Famel and male between 55 - 85 year old. in hemodyalisis treatment
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hemodyalisis patients Intradyalisis without exercise programe group of patients in hemodialysis who performs the exercise program Hemodyalisis patients Intradyalisis with exercise programe group of patients in hemodialysis who performs the exercise program
- Primary Outcome Measures
Name Time Method Change from baseline in Biochemical values, Protein KLOTHO at 3 month and 6 month 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 Outcome Measures
Name Time Method Change from baseline in Physical performance sit and stand at 6 month Baseline and 6 month patients' performance in the 10-repetition sit to stand (STS-10), The STS-10, an index of lower-extremity strength, measures the time (in seconds) required to perform 10 consecutive repetitions of sitting down and getting up from a chair. Participants began the test with their arm crossed on their chest and sitting with their back against the chair. They were instructed to perform the task "as fast as possible," starting and finishing at the sitting position. Time was measured with a stopwatch (ONstart 100, Geonaute, France) to the nearest 0.1 second.
Change from baseline in Physical performance 6MWT at 6 month Baseline and 6 month The 6MWT was used as a marker of endurance capacity. It was performed on a 17-meter corridor with marks on every meter, and time was measured with a chronometer. (ONstart 100, Geonaute, France). Participants were asked to cover the longest distance possible during six minutes by walking (not running) continuously and turning around at the final mark. No verbal encouragement was given during the test; however, feedback regarding the remaining time was available. Participants were allowed to rest during the test, and to use any ambulation aid that they used during daily life.
Change from baseline in Physical performance handgrip force at 6 month Baseline and 6 month Maximal isometric handgrip force has been suggested as a useful tool for the continuous assessment of muscle mass and function in dialysis patients. It was measured in both hands using a manual dynamometer (T.K.K.5401, Takei Scientific Instruments, Japan) while participants were in a standing position, with the arm extended and parallel to the body, and without moving the wrist. They performed two maximal repetitions with each hand interspersed with one-minute rests, and the mean of all four trials was analyzed.
Change from baseline in Mental and health status (Beck Depression Inventory) at 6 month Baseline and 6 month Changes in depression symptoms were assessed using the Beck Depression Inventory (BDI). In this self-reported questionnaire 21 items are rated on a four-point severity scale and summed to give a total score, being a higher score suggestive of more severe depression. The BDI has proven a valid depression screening tool in dialysis patients, being one of the most commonly used questionnaires to assess this condition in this patient population. The Scale of this questionaire is: No depression (0 - 13 points); Low depression (14 - 19 points); moderate depression (20 - 28 points); several depression (≥29 points)
Change from baseline in Mental and health status (Health-related QoL <HRQoL> ) at 6 month Baseline and 6 month Health-related QoL (HRQoL) was assessed using the Short-Form 12 (SF-12) health survey, a short version of the SF-36. A physical (PCS) and a mental component score (MCS) are calculated from this self-reported questionnaire. SF-12 has proven reliable and valid in dialysis patients, being associated with short-term and long-term mortality in this population. The questionnaire is divided into three dimensions which have the following scales: EQ-EVA (visual analog scale) scores from 0 to 100 where 0 is the worst health state imaginable and 100 the best state, EQ-Descriptive. Better state of health self-perceived (11111) and worse (33333) depending on the answers given in each one of the sections of the questionnaire and EQ-Index. Better health status: values of 1 or close to 1 and the states closest to death.
Change from baseline in Mental and health status (level of anxiety) at 6 month Baseline and 6 month the State-Trait Anxiety Inventory (STAI), The score range ranges from 0 to 60 points, so that high scores reflect greater anxiety. The scores obtained are transformed into decatypes (10 decatypes).
Hemogram and Biochemical values , (hemoglobin, hematocrit and mean corpuscular volume ) Baseline Red blood cells, hemoglobin, hematocrit and mean corpuscular volume were determined from whole blood anticoagulated with EDTA in a Sysmex XI-1000i hematological analyzer. with normal values for hemoglobin 14± 2 (g/dL) for women and of 16± 2 (g/dL) for men, for hematocrit 42± 5 % for women and of 47± 6 % for men and for corpuscular volumen 90 ± 7 (fL) for women and for men.
Hemogram and Biochemical values (Iron, albumin, calcium and phosporus) Baseline Iron, albumin, calcium and phosphorus were made by spectrophotometry from serum in a Cobas Integra 400 device. , considered as normal values Total calcium mg/100 mL 8,5-10,5; Phosphorus mg/100 mL 2,2-4,4; albumin g/100 mL 3-5 and for Iron 60 a 170 mcg/dL
Change in Body Composition, Body mass index (BMI) Baseline, 3 months and 6 ,months The age in years; height in centimeters (tallimeter Ano Sayol SL, Barcelona, Spain); weight in kilograms (Inbody 720, Microcaya) and we can derive from this data the variable of Body Mass Index (BMI) calculated as weight (kg)/height (m2).
Change in Body Composition, Body Fat Index Baseline, 3 months and 6 ,months For determinate this variable of the body composition will be use a Bioelectrical impedance machine Inbody 720, Microcaya. The datas of Total Body Fat Index shown in percentage and kilograms.
Change in Body Composition, Fat Mass by body segment Baseline, 3 months and 6 ,months For determinate this variable of the body composition will be use a Bioelectrical impedance machine Inbody 720, Microcaya. The datas of Fat Mass shown in kilograms. This is divided in upper limb and lower limb on both side (left and right) and Trunk Fat Mass.
Change in Body Composition, Total Muscle Mass Baseline, 3 months and 6 ,months For determinate this variable of the body composition will be use a Bioelectrical impedance machine Inbody 720, Microcaya. The datas of Total Muscle Mass shown in kilograms. This is divided in upper limb and lower limb on both side (left and right) and Trunk Muscle Mass.
Hemogram and Biochemical values (Transferrin) Baseline Transferrin was obtained in a Cobas Integra 400 device by immunoturbidimetry technique from serum, considered as normal values for men and women 200-400 mg/dL (23-45 mmol/L).
Hemogram and Biochemical values (Ferritin and PTH) Baseline Ferritin and PTH were determined from serum by chemiluminescence technique using an Elecsys 2010 equipment. with normal values for ferritin 12-300 ng/mL for men and 12-200 ng/mL for women and for PTH 8 - 51 pg/mL (8 - 51 ng/L) for men and women.
Hemogram and Biochemical values (The ions (Na +, K + and Cl-)) Baseline The ions (Na +, K + and Cl-) were determined in serum using a Cobas Integra 400 device by means of a selective electrode module.
Hemogram and Biochemical values (The transferrin saturation index (IST)) Baseline The transferrin saturation index (IST) was obtained through the following formula: IST (%) = (serum iron concentration (M)) / (2 x transferrin concentration (M)) \* 100. considered as normal values for men and women 20 - 50%
Sociocultural aspects Baseline It is assumed that they are linked to the center where the study will be conducted. However, the EXERNET questionnaire will be included and it does not have cut points since it collects general and descriptive data of the subject.