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

NCT03579537 | Completed

• 3 other identifiers: Universidad Politécnica MadridMGGrossMargarita Pérez Ruiz
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hemolysis

Keywords

Hemodialysis; Klotho Protein; Excercise; Lifestyle condition

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 3 month and 6 month

Secondary Outcomes (17)

• Change from baseline in Physical performance sit and stand at 6 month

  Baseline and 6 month

• Change from baseline in Physical performance 6MWT at 6 month

  Baseline and 6 month

• Change from baseline in Physical performance handgrip force at 6 month

  Baseline and 6 month

• Change from baseline in Mental and health status (Beck Depression Inventory) at 6 month

  Baseline and 6 month

• Change from baseline in Mental and health status (Health-related QoL <HRQoL> ) at 6 month

  Baseline and 6 month

Study Arms (1)

Hemodyalisis patients

EXPERIMENTAL

group of patients in hemodialysis who performs the exercise program

Other: Intradyalisis without exercise programe; Other: Intradyalisis with exercise programe

Interventions

Intradyalisis without exercise programe OTHER

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).

Hemodyalisis patients

Intradyalisis with exercise programe OTHER

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)

Hemodyalisis patients

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Famel and male between 55 - 85 year old. in hemodyalisis treatment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Politecnica de Madrid: lead
• Universidad Europea de Madrid: collaborator
• Fundación Renal Iñigo Alvarez De Toledo: collaborator

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor for Sport Nutrition and Exercise Physiology

Model Details: One group who perform 3 first month just with normal treatment of hemodialysis and the next 3 month exercise intervention. (6 months in total)

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: July 6, 2018
• Study Start: July 22, 2014
• Primary Completion: July 15, 2015
• Study Completion: October 30, 2015
• Last Updated: July 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share