Clinical trial NCT05374863: Intradialytic Physiotherapy in Patients With Chronic Kidney Disease
Official title: Evaluation and Intervention of Intradialytic Physical Therapy in Patients With Chronic Kidney Disease: a Randomized Clinical Trial Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Renal Diseases
Keywords: Chronic kidney disease
Hemodialisis
Exercise
Neuromuscular electrical stimulation
Lead sponsor: Federal University of Espirito Santo
Sponsor class: OTHER
Collaborators: name: Hospital Universitário Cassiano Antônio Moraes
First posted: 2022-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a controlled, randomized, double-blind clinical trial with an intention-to-treat analysis.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improved Functional Capacity
timeFrame: Baseline, pre-intervention/immediately after intervention.
measure: Improved Peripheral muscle strength
timeFrame: Baseline, pre-intervention/immediately after intervention.
Secondary outcomes:
measure: Improved Cardiorespiratory capacity
timeFrame: Baseline, pre-intervention/immediately after intervention.
measure: Improved Capacity of life.
timeFrame: Baseline, pre-intervention/immediately after intervention.
Other outcomes:
Locations:
city: Vitória
country: Brazil
facility: Federal University of Espírito Santo
state: Espírito Santo
Study officials:
affiliation: Federal University of Espírito Santo
name: Marcela c Barbalho, PhD
role: PRINCIPAL_INVESTIGATOR
References: