Effects of Exercise on Physical Fitness Among Hemodialysis Patients With Chronic Kidney Disease

June 25, 2018 updated by: Marcela Gonzalez Gross, Universidad Politecnica de Madrid

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Hemodyalisis patients
group of patients in hemodialysis who performs the exercise program
Other: Intradyalisis without exercise programe
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).
Other: Intradyalisis with exercise programe
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 3 month and 6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Physical performance sit and stand at 6 month
Time Frame: 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.
Baseline and 6 month
Change from baseline in Physical performance 6MWT at 6 month
Time Frame: 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.
Baseline and 6 month
Change from baseline in Physical performance handgrip force at 6 month
Time Frame: 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.
Baseline and 6 month
Change from baseline in Mental and health status (Beck Depression Inventory) at 6 month
Time Frame: 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)
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
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.
Baseline and 6 month
Change from baseline in Mental and health status (level of anxiety) at 6 month
Time Frame: 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).
Baseline and 6 month
Hemogram and Biochemical values , (hemoglobin, hematocrit and mean corpuscular volume )
Time Frame: 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.
Baseline
Hemogram and Biochemical values (Iron, albumin, calcium and phosporus)
Time Frame: 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
Baseline
Hemogram and Biochemical values (Transferrin)
Time Frame: 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).
Baseline
Hemogram and Biochemical values (Ferritin and PTH)
Time Frame: 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.
Baseline
Hemogram and Biochemical values (The ions (Na +, K + and Cl-))
Time Frame: Baseline
The ions (Na +, K + and Cl-) were determined in serum using a Cobas Integra 400 device by means of a selective electrode module.
Baseline
Hemogram and Biochemical values (The transferrin saturation index (IST))
Time Frame: 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%
Baseline
Change in Body Composition, Body mass index (BMI)
Time Frame: 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).
Baseline, 3 months and 6 ,months
Change in Body Composition, Body Fat Index
Time Frame: 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.
Baseline, 3 months and 6 ,months
Change in Body Composition, Fat Mass by body segment
Time Frame: 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.
Baseline, 3 months and 6 ,months
Change in Body Composition, Total Muscle Mass
Time Frame: 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.
Baseline, 3 months and 6 ,months
Sociocultural aspects
Time Frame: 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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Politecnica de Madrid

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Europea de Madrid
Fundación Renal Iñigo Alvarez De Toledo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Universidad Politecnica Madrid
  • MGGross (OTHER: Universidad Politécnica de Madrid)
  • Margarita Pérez Ruiz (OTHER: Universidad Europea de Madrid)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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