HemolysisNCT03579537
Effects of Exercise on Physical Fitness Among Hemodialysis Patients With Chronic Kidney Disease
A study testing Intradyalisis without exercise programe and Intradyalisis with exercise programe in people with Hemolysis, run by Universidad Politecnica de Madrid.
Trial summary
Regular physical exercise was adapted to the situation of the patient with hemodialysis to help improve the quality of life of the patient Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Hemolysis
- What is being tested?
- Intradyalisis without exercise programe and Intradyalisis with exercise programe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 22 Jul 2014to 30 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Famel and male between 55 - 85 year old. in hemodyalisis treatment
Who cannot join
- 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,
Show all 11Show fewer
- 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.
About this study
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
Regular physical exercise was adapted to the situation of the patient with hemodialysis to help improve the quality of life of the patient
Read the 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
- Conditions
- Hemolysis
- Being tested
- Intradyalisis without exercise programe, Intradyalisis with exercise programe
- Keywords
- Hemodialysis, Klotho Protein, Excercise, Lifestyle condition
- Medical subject headings
- Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradyalisis without exercise programeOther
patients on hemodialysis are evaluated with all the variables at first (T1) and without intervening in the treatment for 3 months they are evaluated again (T2).
Intradyalisis with exercise programeOther
After 3 first month without intervention and also during the time of hemodialysis, the patients star the exercise programe, the first part of the session, an exercise was carried out for cardiovascular work (pedaling on ergometer) and muscle toning, with special attention to the muscular development of the lower limbs (exercises with elastic bands and / or weighted ankles). The session increased in duration and intensity as the physical action program progressed throughout the duration of the permitted period (3 months) and always attending to the individual needs of each subject. In addition, each of the participants will be given a series of recommendations of exercise practice to be carried out during non-hemodialysis days, in order to complement the work done during the sessions.3 month later the investigator evaluated all the variable again (T3)
| Study group | Role | What they receive |
|---|---|---|
| Hemodyalisis patients | Experimental | group of patients in hemodialysis who performs the exercise program Receives: Other: Intradyalisis without exercise programe; Other: Intradyalisis with exercise programe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Biochemical values, Protein KLOTHO at 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.
Measured: baseline, 3 month and 6 month
Secondary outcomes (17)
Change from baseline in Physical performance sit and stand at 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.
Measured: Baseline and 6 month
Change from baseline in Physical performance 6MWT at 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.
Measured: Baseline and 6 month
Change from baseline in Physical performance handgrip force at 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.
Measured: Baseline and 6 month
Change from baseline in Mental and health status (Beck Depression Inventory) at 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)
Measured: Baseline and 6 month
Change from baseline in Mental and health status (Health-related QoL <HRQoL> ) at 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.
Measured: Baseline and 6 month
Change from baseline in Mental and health status (level of anxiety) at 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).
Measured: Baseline and 6 month
Hemogram and Biochemical values , (hemoglobin, hematocrit and mean corpuscular volume )
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.
Measured: Baseline
Hemogram and Biochemical values (Iron, albumin, calcium and phosporus)
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
Measured: Baseline
Hemogram and Biochemical values (Transferrin)
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).
Measured: Baseline
Hemogram and Biochemical values (Ferritin and PTH)
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.
Measured: Baseline
Hemogram and Biochemical values (The ions (Na +, K + and Cl-))
The ions (Na +, K + and Cl-) were determined in serum using a Cobas Integra 400 device by means of a selective electrode module.
Measured: Baseline
Hemogram and Biochemical values (The transferrin saturation index (IST))
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%
Measured: Baseline
Change in Body Composition, Body mass index (BMI)
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).
Measured: Baseline, 3 months and 6 ,months
Change in Body Composition, Body Fat Index
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.
Measured: Baseline, 3 months and 6 ,months
Change in Body Composition, Fat Mass by body segment
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.
Measured: Baseline, 3 months and 6 ,months
Change in Body Composition, Total Muscle Mass
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.
Measured: Baseline, 3 months and 6 ,months
Sociocultural aspects
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start22 Jul 2014
- Primary completion15 Jul 2015
- Study completion30 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Europea de Madrid, Fundación Renal Iñigo Alvarez De Toledo
- Responsible party
- Principal investigator, Marcela Gonzalez Gross, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579537
- Sponsor's protocol ID
- Universidad Politécnica Madrid
- Other IDs
- MGGross, Margarita Pérez Ruiz
- Status last verified
- Jun 2018
- First submitted
- 18 May 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03579537
- Acronym / sponsor ID
- Universidad Politécnica Madrid
- Conditions
- Hemolysis
- Keywords
- Hemodialysis, Klotho Protein, Excercise, Lifestyle condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Collaborators
- Universidad Europea de Madrid, Fundación Renal Iñigo Alvarez De Toledo
- Study start
- 22 Jul 2014 (actual)
- Primary completion
- 15 Jul 2015 (actual)
- Study completion
- 30 Oct 2015 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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)
| Arm | Type | Receives |
|---|---|---|
| Hemodyalisis patients | Experimental | Other: Intradyalisis without exercise programe, Other: Intradyalisis with exercise programegroup of patients in hemodialysis who performs the exercise program |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Famel and male between 55 - 85 year old. in hemodyalisis treatment
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradyalisis without exercise programepatients on hemodialysis are evaluated with all the variables at first (T1) and without intervening in the treatment for 3 months they are evaluated again (T2). | Other | Hemodyalisis patients |
| Intradyalisis with exercise programeAfter 3 first month without intervention and also during the time of hemodialysis, the patients star the exercise programe, the first part of the session, an exercise was carried out for cardiovascular work (pedaling on ergometer) and muscle toning, with special attention to the muscular development of the lower limbs (exercises with elastic bands and / or weighted ankles). The session increased in duration and intensity as the physical action program progressed throughout the duration of the permitted period (3 months) and always attending to the individual needs of each subject. In addition, each of the participants will be given a series of recommendations of exercise practice to be carried out during non-hemodialysis days, in order to complement the work done during the sessions.3 month later the investigator evaluated all the variable again (T3) | Other | Hemodyalisis patients |
Primary outcome
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.
17 secondary outcomes
Change from baseline in Physical performance sit and stand at 6 month
Time frame: Baseline and 6 month
Change from baseline in Physical performance 6MWT at 6 month
Time frame: Baseline and 6 month
Change from baseline in Physical performance handgrip force at 6 month
Time frame: Baseline and 6 month
Change from baseline in Mental and health status (Beck Depression Inventory) at 6 month
Time frame: Baseline and 6 month
Change from baseline in Mental and health status (Health-related QoL <HRQoL> ) at 6 month
Time frame: Baseline and 6 month
Change from baseline in Mental and health status (level of anxiety) at 6 month
Time frame: Baseline and 6 month
Hemogram and Biochemical values , (hemoglobin, hematocrit and mean corpuscular volume )
Time frame: Baseline
Hemogram and Biochemical values (Iron, albumin, calcium and phosporus)
Time frame: Baseline
Hemogram and Biochemical values (Transferrin)
Time frame: Baseline
Hemogram and Biochemical values (Ferritin and PTH)
Time frame: Baseline
Hemogram and Biochemical values (The ions (Na +, K + and Cl-))
Time frame: Baseline
Hemogram and Biochemical values (The transferrin saturation index (IST))
Time frame: Baseline
Change in Body Composition, Body mass index (BMI)
Time frame: Baseline, 3 months and 6 ,months
Change in Body Composition, Body Fat Index
Time frame: Baseline, 3 months and 6 ,months
Change in Body Composition, Fat Mass by body segment
Time frame: Baseline, 3 months and 6 ,months
Change in Body Composition, Total Muscle Mass
Time frame: Baseline, 3 months and 6 ,months
Sociocultural aspects
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intradyalisis without exercise programe and Intradyalisis with exercise programe in people with Hemolysis, run by Universidad Politecnica de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Biochemical values, Protein KLOTHO at 3 month and 6 month (time frame: baseline, 3 month and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.