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Efficacy of an Intradialysis Combined Training Program on Disability Level and Physical Performance. (PTH-CKD0113)

Primary Purpose

Chronic Renal Failure

Status

Approved for marketing

Phase

Locations

Study Type

Expanded Access

Intervention

intradialytic physical training program

About this trial

This is an expanded access trial for Chronic Renal Failure focused on measuring Hemodialysis, Skeletal muscle, Exercise, Rehabilitation, Disability Evaluation

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT02883309

First Posted

August 25, 2016

Last Updated

September 28, 2016

Sponsor

Universidad Austral de Chile

Collaborators

Nephrocare Portugal

1. Study Identification

Unique Protocol Identification Number

NCT02883309

Brief Title

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

Acronym

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.

Study Type

Expanded Access

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Approved for marketing

Study Start Date

November 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidad Austral de Chile

Collaborators

Nephrocare Portugal

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Failure

Keywords

Hemodialysis, Skeletal muscle, Exercise, Rehabilitation, Disability Evaluation

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

intradialytic physical training program

Intervention Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: