Clinical trial NCT02883309: Efficacy of an Intradialysis Combined Training Program on Disability Level and Physical Performance.
Official title: Efficacy of an Intradialysis Combined Muscle Strength and Cardiorespiratory Capacity Training Program on Disability Level and Physical Performance, in Patients With Chronic Renal Failure at a Kidney Replacement Therapy Unit.
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Chronic Renal Failure
Keywords: Hemodialysis
Skeletal muscle
Exercise
Rehabilitation
Disability Evaluation
Lead sponsor: Universidad Austral de Chile
Sponsor class: OTHER
Collaborators: name: Nephrocare Portugal
First posted: 2016-08-30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The patient subjected to hemodialysis has a low physical capacity due to being advanced in years and the complexity of the process, which is encouraged by family members and caregivers who lead them to a total dependence. The Intradialytic physical exercise is presented as an alternative to counteract this functional deterioration of patients with terminal chronic kidney failure.

Detailed description: Objective To evaluate the impact of the intradialytic physical training program on the level of disability and physical performance in patients subjected to hemodialysis.

Materials and methods 18 patients subjected to hemodialysis, whose ages ranged from 54 to 84 (10 women) were included in the study. Nine of these patients participated in a combined training program, which lasted 12 weeks, the training sessions were carried out within each dialysis session, the working session involved a warm-up period, aerobic exercise with pedals, or strength exercises based on free-weight depending on the training stage. The Borg scale and the heart rate reserve were used to control the training intensity. The disability level was evaluated at the beginning and end of the study through the World Health Organization Disability Assessment Schedule II, the six minutes walk test (6MWT), quadriceps strength, Kt/V, serum levels of potassium and creatinine.

Outcomes One subject belonging to the experimental group did not complete the training due to problems in the venous access during the 1st month of training. 8 patients in to the experimental group showed significant improvements in the 6MWT, quadriceps strength and decrease in the level of disability. No changes were observed in the control group. No significant changes were found in the serum levels of potassium and creatine.

Conclusions An Intradialytic physical training program achieved a substantial decrease in the level of disability, and an improvement of aerobic capacity and muscle strength. The study was funded by the extension office of the Austral University of Chile.

Eligibility criteria: Inclusion Criteria:

* Patients which are subject to process of hemodialysis via arteriovenous fistula in dialysis unit Valdivia.
* Which are between 60-80 years.
* Therapy Dialysis for more than 3 months period.
* Submit 24 or more points on the Mini-mental state test.

Exclusion Criteria:

* Inability to understand orders.
* Dyspnea at rest.
* Hospitalized one month before surgery.
* Diseases Cerebrovascular transient ischemic attacks.
* Lower limb amputation (ankle presence) that this orthopedic prosthesis.
* Syndrome Acute coronary.
* Congestive heart failure or severe pneumonia.
* Patients with uncontrolled diabetes pharmacologically or are not within the appropriate standards of glucose for training.
* Patients with uncontrolled hypertension pharmacologically or are not within the proper blood pressure standards for training.
* Persistent Hyperkalemia .
* Angina at rest.
* Lung-disease which results in adverse effects.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Austral de Chile
name: Paula I Moscoso, Mph PTh
role: STUDY_CHAIR
affiliation: Universidad Austral de Chile
name: Roberto G Mancilla, Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Austral de Chile
name: Cesar E Gonzalez, Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Austral de Chile
name: Manuel Monrroy, Msc(c) PTh
role: STUDY_DIRECTOR
affiliation: Universidad Austral de Chile
name: Lizzy Orellana, MD
role: STUDY_DIRECTOR
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