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AzTrials

Chronic Kidney DiseasesEJERINTRANCT05207527

Intradialisis Physical Exercise in Quality of Life and Health

A study testing cardiovascular exercise, Muscle strength and Mixed in people with Chronic Kidney Diseases, run by Universidad del Rosario.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Evaluate the effectiveness of different modalities of physical exercise about clinical health indicators and quality of life of patients with chronic kidney disease undergoing hemodialysis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Diseases
What is being tested?
cardiovascular exercise, Muscle strength and Mixed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
15 Feb 2025to 29 Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Include participants with stage five of chronic kidney disease,
  • People over 18 years old.
  • Their participation is voluntary and their have signed the informed consent form.
  • Persons that are undergoing hemodialysis for at least 3 months.
  • Persons have ability to do exercise protocols.
  • Persons have the approval by nephrologist doctor and deportologist for to do the study according to the results of initial medical assessment.

Who cannot join

  • Surgical intervention to least 6 months.
  • Skeletal limitations that affect exercise performance.
  • Psychiatric disorders and psychological such as depression, anxiety that could be affect participation of the study.
  • Body Mass Index greater than 30 kg/m2 and not less than 18.5 kg/m2.
  • Hemodialysis catheter dysfunction or infection as well as participation in home exercise programs.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Gabriela García-Laguna, PI contact

+573213781814

Dayan.garcia@urosario.edu.co

About this study

Official title: Design and Effectiveness of Different Physical Exercise-based Interventions About Health Indicators and Quality of Life in Patients With Chronic Kidney Disease in Hemodialysis

Evaluate the effectiveness of different modalities of physical exercise about clinical health indicators and quality of life of patients with chronic kidney disease undergoing hemodialysis.

Read the detailed description

Objective of this study will be evaluate the effectiveness of different modalities of physical exercise about clinical health indicators and quality of life of patients with chronic kidney disease undergoing on hemodialysis. This study will include to 100 people over 18 years old who are stage five of chronic kidney disease and go to hemodialysis units of Bogota D.C, Colombia.

The ransomized controlled clinical trial to clusters, with 3 groups of intervetion and 1 control, double masking. All the participants receive information on informed consent. The study was approved by the ethics committee of the Universidad del Rosario

Being tested
cardiovascular exercise, Muscle strength, Mixed
Keywords
Chronic kidney disease, Health indicators, Quality of life, Hemodialysis, Peritoneal dialysis, Cardiovascular exercise, Resistance exercise
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cardiovascular exerciseOther

    Also called No aplicable

    Exercise that mainly stimulates the cardiovascular and respiratory systems.

  • Muscle strengthOther

    Also called No aplicable

    Exercise that primarily stimulates the musculoskeletal system.

  • MixedOther

    Also called No aplicable

    Exercise that stimulates the musculoskeletal, cardiovascular and respiratory systems.

Study groups in NCT05207527
Study groupRoleWhat they receive
Cardiovascular exerciseExperimentalCycloergometer
Receives: Other: cardiovascular exercise
Muscle strengthExperimentalStrength exercises will be performed during the hemodialysis session.
Receives: Other: Muscle strength
MixedExperimentalBoth aerobic and muscular strength exercises will be performed.
Receives: Other: cardiovascular exercise; Other: Muscle strength; Other: Mixed
ControlNo interventionConventional treatment or dyalisis usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health indicators - Dialysis efficiency

    Dialysis efficiency will be measured by analysis through biochemical methods in blood serum (KT/V).

    Measured: 6 months

  2. Health indicators - KT/V

    It is an indicator of the rate of clearance of urea and other wastes by the dialyzer.

    Measured: 6 months

  3. Health indicators - Sarcopenia

    Sarcopenia will be measured by means of dynamometry, in the upper limb it will be evaluated using a handgrip dynamometer Participants will be instructed to stand with their arms fully extended by gradually and continuously squeezing their grip until they reach their maximum strength for at least 2 seconds, the test will be performed twice. In lower limb will be performed by means of lower limb dynamometer in which the subject holds the center of the bar, palms down, head straight and back straight, flexes the knees at an angle of 120° and the length of the chain is adjusted so that the bar is in the crease formed between the thigh and the trunk. The subject can place his hands in the middl

    Measured: 6 months

  4. Kidney Disease and Quality of Life (KDQOL-36)

    This will be measured by means of the Kidney Disease and Quality of Life Questionnaire (KDQOL-36) which is defined as a specific questionnaire for patients with kidney disease on dialysis, developed by the Kidney Disease Quality of Life Working Group as a specific self-report measure of health-related quality of life or perceived health in these individuals. It is a self-report questionnaire that combines the generic SF-36 health survey instrument and disease-specific components to assess the health-related quality of life of patients with chronic kidney disease. The minimum value is 0 and the maximum value is 100. A higher score means a better quality of life

    Measured: 6 months

  5. Physical condition - Body composition1

    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of body mass index, visceral fat percentage, total body fat and muscle percentage.

    Measured: 6 months

  6. Physical condition - Body composition2

    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of body mass index.

    Measured: 6 months

  7. Physical condition - Body composition3

    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of visceral fat percentage.

    Measured: 6 months

  8. Physical condition - Body composition4

    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in percentage of total body fat.

    Measured: 6 months

  9. Physical condition - Body composition5

    This variable will be measured by means of bioimpedance, which is defined as a non-invasive method, where the electrical properties of the human body are used to estimate body water and the different body tissues, obtaining results in body muscle percentage.

    Measured: 6 months

  10. Muscle strength

    The muscle strength will be measured by means of dynamometry, in the upper limb it will be evaluated using a handgrip dynamometer Participants will be instructed to stand with their arms fully extended by gradually and continuously squeezing their grip until they reach their maximum strength for at least 2 seconds, the test will be performed twice. In lower limb will be performed by means of lower limb dynamometer in which the subject holds the center of the bar, palms down, head straight and back straight, flexes the knees at an angle of 120° and the length of the chain is adjusted so that the bar is in the crease formed between the thigh and the trunk. The subject can place his hands in the middl

    Measured: 6 months

  11. Fatigue

    This variable will be measured by means of the Fatigue Severity Scale created by Krupp for the assessment of fatigue. It consists of 9 items with a Likert-type response with 7 possibilities, of increasing intensity and scoring between 1 and 7, the total is given with the sum of all items. Its objective is to determine the severity of fatigue in patients with renal disease.

    Measured: 6 months

  12. Functional capacity - SPPB

    This variable will be measured by means of a questionnaire called Short Physical Performance Battery. The purpose of this test is to evaluate the functioning of the lower extremities in the elderly and it is applied to older adults who have the ability to transfer from sitting to standing autonomously and without the help of the upper limbs.

    Measured: 6 months

  13. Functional capacity -6MWT

    The functional capacity will also be measured by means of the 6-minute test, which is defined as a constant load stress test that measures the distance a person can walk in a period of six minutes, at a fast pace, on a flat, hard surface.

    Measured: 6 months

  14. Functional capacity - 2MT

    The functional capacity will also be measured by means of the two-minute stationary gait test, which consists of the individuals evaluated marching in place as fast as possible for 2 minutes; reference values have been published for adults between 60 and 94 years of age.

    Measured: 6 months

Secondary outcomes (1)

  1. Depression and anxiety (Beck Scale)

    This will be measured by means of the Beck Depression and Anxiety Scale. It is a self-assessment scale that primarily assesses the clinical symptoms of melancholy and intrusive thoughts present in depression.

    It is the one with the highest percentage of cognitive symptoms, highlighting also the absence of motor and anxiety symptoms. It is commonly used to assess the severity of the disease. Scale values range from 0 to 63, a higher score represents a worse outcome.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start15 Feb 2025 (estimated)
  3. Primary completion12 Oct 2028 (estimated)
  4. Study completion29 Nov 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
There will be 4 parallel groups, 3 intervention and 1 control group.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05207527
Sponsor's protocol ID
DVO005 769-CV1091
Acronym
EJERINTRA
Status last verified
Jun 2024
First submitted
22 Sep 2021
Last updated
13 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chan D, Cheema BS. Progressive Resistance Training in End-Stage Renal Disease: Systematic Review. Am J Nephrol. 2016;44(1):32-45. doi: 10.1159/000446847. Epub 2016 Jun 30.

    PubMed 27355619

  • Chung YC, Yeh ML, Liu YM. Effects of intradialytic exercise on the physical function, depression and quality of life for haemodialysis patients: a systematic review and meta-analysis of randomised controlled trials. J Clin Nurs. 2017 Jul;26(13-14):1801-1813. doi: 10.1111/jocn.13514. Epub 2017 Mar 20.

    PubMed 27532211

  • Ferrari F, Helal L, Dipp T, Soares D, Soldatelli A, Mills AL, Paz C, Tenorio MCC, Motta MT, Barcellos FC, Stein R. Intradialytic training in patients with end-stage renal disease: a systematic review and meta-analysis of randomized clinical trials assessing the effects of five different training interventions. J Nephrol. 2020 Apr;33(2):251-266. doi: 10.1007/s40620-019-00687-y. Epub 2019 Dec 21.

    PubMed 31865607

  • Molsted S, Bjorkman ASD, Lundstrom LH. Effects of strength training to patients undergoing dialysis: a systematic review. Dan Med J. 2019 Jan;66(1):A5526.

    PubMed 30573007

  • Pu J, Jiang Z, Wu W, Li L, Zhang L, Li Y, Liu Q, Ou S. Efficacy and safety of intradialytic exercise in haemodialysis patients: a systematic review and meta-analysis. BMJ Open. 2019 Jan 21;9(1):e020633. doi: 10.1136/bmjopen-2017-020633.

    PubMed 30670499

  • Scapini KB, Bohlke M, Moraes OA, Rodrigues CG, Inacio JF, Sbruzzi G, Leguisamo CP, Sanches IC, Tourinho Filho H, Irigoyen MC. Combined training is the most effective training modality to improve aerobic capacity and blood pressure control in people requiring haemodialysis for end-stage renal disease: systematic review and network meta-analysis. J Physiother. 2019 Jan;65(1):4-15. doi: 10.1016/j.jphys.2018.11.008. Epub 2018 Dec 21.

    PubMed 30581137

  • Young HML, March DS, Graham-Brown MPM, Jones AW, Curtis F, Grantham CS, Churchward DR, Highton P, Smith AC, Singh SJ, Bridle C, Burton JO. Effects of intradialytic cycling exercise on exercise capacity, quality of life, physical function and cardiovascular measures in adult haemodialysis patients: a systematic review and meta-analysis. Nephrol Dial Transplant. 2018 Aug 1;33(8):1436-1445. doi: 10.1093/ndt/gfy045.

    PubMed 29608708

  • Afsar B, Siriopol D, Aslan G, Eren OC, Dagel T, Kilic U, Kanbay A, Burlacu A, Covic A, Kanbay M. The impact of exercise on physical function, cardiovascular outcomes and quality of life in chronic kidney disease patients: a systematic review. Int Urol Nephrol. 2018 May;50(5):885-904. doi: 10.1007/s11255-018-1790-4. Epub 2018 Jan 17.

    PubMed 29344881

  • Andrade FP, Rezende PS, Ferreira TS, Borba GC, Muller AM, Rovedder PME. Effects of intradialytic exercise on cardiopulmonary capacity in chronic kidney disease: systematic review and meta-analysis of randomized clinical trials. Sci Rep. 2019 Dec 5;9(1):18470. doi: 10.1038/s41598-019-54953-x.

    PubMed 31804617

  • Bohm J, Monteiro MB, Andrade FP, Veronese FV, Thome FS. Acute effects of intradialytic aerobic exercise on solute removal, blood gases and oxidative stress in patients with chronic kidney disease. J Bras Nefrol. 2017 Apr-Jun;39(2):172-180. doi: 10.5935/0101-2800.20170022. Epub 2017 Apr 27. English, Portuguese.

    PubMed 28489182

  • Anding K, Bar T, Trojniak-Hennig J, Kuchinke S, Krause R, Rost JM, Halle M. A structured exercise programme during haemodialysis for patients with chronic kidney disease: clinical benefit and long-term adherence. BMJ Open. 2015 Aug 27;5(8):e008709. doi: 10.1136/bmjopen-2015-008709.

    PubMed 26316654

  • Clarkson MJ, Bennett PN, Fraser SF, Warmington SA. Exercise interventions for improving objective physical function in patients with end-stage kidney disease on dialysis: a systematic review and meta-analysis. Am J Physiol Renal Physiol. 2019 May 1;316(5):F856-F872. doi: 10.1152/ajprenal.00317.2018. Epub 2019 Feb 13.

    PubMed 30759022

  • Salhab N, Karavetian M, Kooman J, Fiaccadori E, El Khoury CF. Effects of intradialytic aerobic exercise on hemodialysis patients: a systematic review and meta-analysis. J Nephrol. 2019 Aug;32(4):549-566. doi: 10.1007/s40620-018-00565-z. Epub 2019 Jan 18.

    PubMed 30659520

  • Smart N, Steele M. Exercise training in haemodialysis patients: a systematic review and meta-analysis. Nephrology (Carlton). 2011 Sep;16(7):626-32. doi: 10.1111/j.1440-1797.2011.01471.x.

    PubMed 21557787

  • Tentori F, Elder SJ, Thumma J, Pisoni RL, Bommer J, Fissell RB, Fukuhara S, Jadoul M, Keen ML, Saran R, Ramirez SP, Robinson BM. Physical exercise among participants in the Dialysis Outcomes and Practice Patterns Study (DOPPS): correlates and associated outcomes. Nephrol Dial Transplant. 2010 Sep;25(9):3050-62. doi: 10.1093/ndt/gfq138. Epub 2010 Apr 13.

    PubMed 20392706

Questions about this trial

What is this clinical trial studying?

A study testing cardiovascular exercise, Muscle strength and Mixed in people with Chronic Kidney Diseases, run by Universidad del Rosario.

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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Jun 2024. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gabriela García-Laguna, PI (+573213781814, Dayan.garcia@urosario.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health indicators - Dialysis efficiency (time frame: 6 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05207527, which also lists 16 linked publications.

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 13 Jun 2024.

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