Intradialytic Physiotherapy in Patients With Chronic Kidney Disease

Marcela Cangussu Barbalho

Status: Enrolling

Conditions: Chronic Renal Diseases

Treatments: Device: Aerobic exercise with cycle ergometer; Device: Neuromuscular electrical stimulation (NMES) - Active; Device: Neuromuscular Electrical Stimulation (NMES) - Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT05374863

27067819.1.0000.5071

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

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

Treatment:

Device: Aerobic exercise with cycle ergometer

Device: Neuromuscular electrical stimulation (NMES) - Active

Control Group

Placebo Comparator group

Description:

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

Treatment:

Device: Neuromuscular Electrical Stimulation (NMES) - Sham

Device: Aerobic exercise with cycle ergometer