Efficacy of an Intradialysis Combined Training Program on Disability Level and Physical Performance.

Chronic Renal Failure Clinical Trial

— PTH-CKD0113  

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.

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT02883309
• Other study ID #: Universidad Austral de Chile
• Secondary ID: 33-2013
• Status: Approved for marketing
• Phase: Phase 0
• First received: August 25, 2016
• Last updated: September 28, 2016
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2016
• Source: Universidad Austral de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Ministry of HealthChile: Comité de Ética Científico
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• intradialytic physical training program
Nine patients participated in the experimental group in a combined training program, which lasted 12 weeks with a frequency of 3 times a week, the training sessions were carried out within each dialysis session during the first 2 hours of the dialysis treatment, 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 the end of the study through the World Health Organization Disability Assessment Schedule II, the aerobic capacity was evaluated through the six minute walk and the limbs strength was evaluated through a dynamometer.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Austral de Chile	Nephrocare Portugal

References & Publications (18)

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* Note: There are 18 references in all — Click here to view all references

External Links

•   e nfermedad renal crónica: causa y prevalencia en la población del Hospital general la Perla
•   Efeitos do exercício físico durante a hemodiálise em indivíduos com insuficiência renal crônica: uma revisão
•   Estudio piloto sobre entrenamiento físico durante hemodiálisis
•   Intradialytic versus home based exercise training in hemodialysis patients: a randomised controlled trial
•   Prescripciòn de ejercicio fìsico para el acondicionamiento cardio-respitatorio
•   Sociedad Chilena de Nefrologia registro de dialisis
•   The epidemiology of chronic kidney disease
•   The epidemiology of chronic kidney disease
•   Whodas II Acta Psiquiatrica