Intradialytic Physiotherapy in Patients With Chronic Kidney Disease
- Conditions
- Chronic Renal Diseases
- Interventions
- Device: Neuromuscular electrical stimulation (NMES) - ActiveDevice: Neuromuscular Electrical Stimulation (NMES) - ShamDevice: Aerobic exercise with cycle ergometer
- Registration Number
- NCT05374863
- Lead Sponsor
- Marcela Cangussu Barbalho
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- Presents symptoms and/or health conditions (cardiovascular, respiratory, neurological, cognitive) that prevent the performance of evaluation tests and participation in the exercise program.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group Aerobic exercise with cycle ergometer Neuromuscular electrical stimulation (NMES) active in the upper limbs for 20 minutes and aerobic exercises on the cycle ergometer for 30 minutes. Control Group Aerobic exercise with cycle ergometer NMES-Sham in upper limbs for 20 minutes and aerobic exercises on a cycle ergometer for 30 minutes. Experimental Group Neuromuscular electrical stimulation (NMES) - Active Neuromuscular electrical stimulation (NMES) active in the upper limbs for 20 minutes and aerobic exercises on the cycle ergometer for 30 minutes. Control Group Neuromuscular Electrical Stimulation (NMES) - Sham NMES-Sham in upper limbs for 20 minutes and aerobic exercises on a cycle ergometer for 30 minutes.
- Primary Outcome Measures
Name Time Method Improved Functional Capacity Baseline, pre-intervention/immediately after intervention. It will be evaluated by the one-minute sit-and-stand test. Patients will be instructed to sit and stand up in a chair as quickly as possible for 1 minute, starting from the sitting position, with their feet on the floor, arms crossed on the chest and back supported on the chair, in addition, they will not receive any type of incentive verbal during the test. The number of repetitions will be recorded, and if the participant is standing at the end of 1 minute, 0.5 repetition will be considered.
Improved Peripheral muscle strength Baseline, pre-intervention/immediately after intervention. It will be evaluated through the handgrip strength being measured using a manual digital dynamometer (Instruthern®, São Paulo, Brazil). The test will be performed three times on each upper limb (right and left), with 1-minute intervals between each execution, the measure with the highest value being considered.
- Secondary Outcome Measures
Name Time Method Improved Cardiorespiratory capacity Baseline, pre-intervention/immediately after intervention. It will be evaluated through the self-administered questionnaire called Duke Activity Status Index (DASI), which is composed of 12 items covering personal care, household activities, sexual activity and recreational activities. Item scores are graded based on metabolic cost measured in metabolic equivalents (METs). Each item with the answer "YES" receives a score ranging from 1.75 to 8.00 points. "NO" answers are scored as 0. The total score ranges from 0 to 58.2 points, with higher scores meaning greater cardiorespiratory capacity. From the result of the sum of the scores of the 12 items, it is possible to estimate the oxygen consumption at the peak of the exercise (VO2peak), since a strong correlation between the DASI and the VO2peak obtained from the cardiopulmonary test (gold standard) has already been demonstrated.
Improved Capacity of life. Baseline, pre-intervention/immediately after intervention. It will be evaluated using the Kidney Disease and Quality of Life Short-Form (KDQOL-SFTM) questionnaire, which is a specific instrument that assesses the quality of life in patients with end-stage renal disease, applicable to patients undergoing some type of dialysis program. . It is a self-administered instrument with 80 items, divided into 19 scales. It is a complete questionnaire, as it includes generic and specific aspects related to kidney disease.
Trial Locations
- Locations (1)
Federal University of Espírito Santo
🇧🇷Vitória, Espírito Santo, Brazil