Intradialytic Physiotherapy in Patients With Chronic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-12-31

Brief Summary

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The objective is to evaluate in adult patients with chronic kidney disease the effect of neuromuscular electrical stimulation (NMES) in the upper limbs associated with a cycle ergometer in the lower limbs, during hemodialysis, on functional capacity and peripheral muscle strength.

The hypothesis is that in people with chronic kidney disease on hemodialysis, the addition of neuromuscular electrical stimulation in the upper limbs associated with aerobic training of the lower limbs is superior to aerobic exercise alone in improving functional capacity, peripheral muscle strength, quality of life, safety intervention and patient adherence.

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Detailed Description

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Objective: To evaluate, in adult patients with chronic kidney disease, the effect of neuromuscular electrical stimulation (NMES) in the upper limbs associated with a cycle ergometer in the lower limbs, during hemodialysis, on functional capacity and peripheral muscle strength.

Methods. This is a controlled, randomized, double-blind, intention-to-treat clinical trial carried out at the Cassiano Antônio Moraes University Hospital (HUCAM). Thirty individuals who will be randomly allocated to an intervention group (ie active NMES on upper limbs for 20 minutes and aerobic exercise on a cycle ergometer for 30 minutes) or a control group (ie NMES-Sham on upper limbs for 20 minutes and aerobic exercise on a cycle ergometer for 30 minutes). The treatment will be carried out for 8 weeks, with 3 weekly sessions totaling 24 sessions. Outcome measures will be collected by trained researchers before treatment (week 0) and at the end of treatment (week 9), always in the second hemodialysis session of the week. Functional capacity, peripheral muscle strength, activity level of daily living, quality of life, intervention safety, patient compliance, hemodialysis filtration rate (KT/V) and renal function (potassium, phosphate and magnesium clearance) will be evaluated.

Impact. This study could potentially provide important information and assist in clinical decision making regarding the combined use of NMES with a cycle ergometer to optimize the clinical benefits of therapeutic exercise in patients with chronic kidney disease.

Conditions

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Chronic Renal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a controlled, randomized, double-blind clinical trial with an intention-to-treat analysis.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

This is a double-blind study, where evaluators and participants will not be aware of the details of the research. All outcomes will be measured by blinded raters as they will not be involved in the randomization process and will not receive details about interventions. All participants will be blinded as to whether or not the NMES will be performed, as both the intervention group and the control group will have the electrodes positioned and will remain there for the same time.

Study Groups

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Experimental Group

Neuromuscular electrical stimulation (NMES) active in the upper limbs for 20 minutes and aerobic exercises on the cycle ergometer for 30 minutes.

Group Type EXPERIMENTAL

Neuromuscular electrical stimulation (NMES) - Active

Intervention Type DEVICE

The NMES will be held for 20 minutes. Biceps musculature and bilateral wrist and finger flexors stimulated. For patients undergoing hemodialysis for fistula in the upper limb, NMES will be performed only in the limb without a fistula. points of points 4 electrodes in each, being 2 points of longitudinal position in the muscular belly of the biceps, and other 2 in the ventral region of the forearm. the parameters: frequency of 80 Hz, pulse frequency of 350 ms, time of 5 seconds and 10 seconds. The possibility will be greater for each patient who will have the contraction. Patients will be instructed to perform an isometric contraction of wrist and finger flexors during electrical stimulation.

Aerobic exercise with cycle ergometer

Intervention Type DEVICE

The exercise will be performed from the adaptation and positioning of a cycle ergometer (Mini Bike E5 Acte Sports®) in front of the hemodialysis chair. Each session will consist of three phases: duration (5 minutes), conditioning (20 minutes) and cool-down (5 minutes). During the development and cool-down phases, patients will be instructed to maintain a lower exercise intensity, with a level between 1 and 3 on the modified BORG scale. In the conditioning phase, patients will be instructed to slightly increase the intensity of the exercise, levels between 4 and 7 on the modified BORG scale. During exercise, patients will be asked every 5 minutes about the level of effort, and the load on the cycle ergometer will be possible to reach an intensity between 4 and 7 on the modified Borg Scale.

Control Group

NMES-Sham in upper limbs for 20 minutes and aerobic exercises on a cycle ergometer for 30 minutes.

Group Type PLACEBO_COMPARATOR

Neuromuscular Electrical Stimulation (NMES) - Sham

Intervention Type DEVICE

It will be performed in the same way as in the experimental group, however, the intensity of the actuality will only reach the sensitive threshold.

Aerobic exercise with cycle ergometer

Intervention Type DEVICE

The exercise will be performed from the adaptation and positioning of a cycle ergometer (Mini Bike E5 Acte Sports®) in front of the hemodialysis chair. Each session will consist of three phases: duration (5 minutes), conditioning (20 minutes) and cool-down (5 minutes). During the development and cool-down phases, patients will be instructed to maintain a lower exercise intensity, with a level between 1 and 3 on the modified BORG scale. In the conditioning phase, patients will be instructed to slightly increase the intensity of the exercise, levels between 4 and 7 on the modified BORG scale. During exercise, patients will be asked every 5 minutes about the level of effort, and the load on the cycle ergometer will be possible to reach an intensity between 4 and 7 on the modified Borg Scale.

Interventions

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Neuromuscular electrical stimulation (NMES) - Active

The NMES will be held for 20 minutes. Biceps musculature and bilateral wrist and finger flexors stimulated. For patients undergoing hemodialysis for fistula in the upper limb, NMES will be performed only in the limb without a fistula. points of points 4 electrodes in each, being 2 points of longitudinal position in the muscular belly of the biceps, and other 2 in the ventral region of the forearm. the parameters: frequency of 80 Hz, pulse frequency of 350 ms, time of 5 seconds and 10 seconds. The possibility will be greater for each patient who will have the contraction. Patients will be instructed to perform an isometric contraction of wrist and finger flexors during electrical stimulation.

Intervention Type DEVICE

Neuromuscular Electrical Stimulation (NMES) - Sham

It will be performed in the same way as in the experimental group, however, the intensity of the actuality will only reach the sensitive threshold.

Intervention Type DEVICE

Aerobic exercise with cycle ergometer

The exercise will be performed from the adaptation and positioning of a cycle ergometer (Mini Bike E5 Acte Sports®) in front of the hemodialysis chair. Each session will consist of three phases: duration (5 minutes), conditioning (20 minutes) and cool-down (5 minutes). During the development and cool-down phases, patients will be instructed to maintain a lower exercise intensity, with a level between 1 and 3 on the modified BORG scale. In the conditioning phase, patients will be instructed to slightly increase the intensity of the exercise, levels between 4 and 7 on the modified BORG scale. During exercise, patients will be asked every 5 minutes about the level of effort, and the load on the cycle ergometer will be possible to reach an intensity between 4 and 7 on the modified Borg Scale.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have chronic kidney disease;
* Undergo hemodialysis at HUCAM for at least 3 months;
* Present a hemoglobin level \> 9 g/dL;
* Present clinical stability for at least 3 months;
* Do not participate in another physical exercise program;
* Present the ability to perform the assessment tests;
* Age equal to or greater than 18 years, and can be of both sexes;
* Accept to participate in the research by signing the informed consent form.

Exclusion Criteria

* Presents symptoms and/or health conditions (cardiovascular, respiratory, neurological, cognitive) that prevent the performance of evaluation tests and participation in the exercise program.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes