Intradialytic Physiotherapy in Patients With Chronic Kidney Disease

NCT05374863 | Unknown

• 1 other identifier: 27067819.1.0000.5071
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Diseases

Keywords

Chronic kidney disease; Hemodialisis; Exercise; Neuromuscular electrical stimulation

Outcome Measures

Primary Outcomes (2)

• Improved Functional Capacity

  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.

  Baseline, pre-intervention/immediately after intervention.

• Improved Peripheral muscle strength

  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.

  Baseline, pre-intervention/immediately after intervention.

Secondary Outcomes (2)

• Improved Cardiorespiratory capacity

  Baseline, pre-intervention/immediately after intervention.

• Improved Capacity of life.

  Baseline, pre-intervention/immediately after intervention.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

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

Control Group

PLACEBO COMPARATOR

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

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

Interventions

Neuromuscular electrical stimulation (NMES) - Active 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.

Experimental Group

Neuromuscular Electrical Stimulation (NMES) - Sham 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.

Control Group

Aerobic exercise with cycle ergometer 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; Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Marcela Cangussu Barbalho: lead
• Hospital Universitário Cassiano Antônio Moraes: collaborator

Study Sites (1)

Federal University of Espírito Santo

Vitória, Espírito Santo, 29075-910, Brazil

RECRUITING

Related Publications (1)

• Rosa MR, de Souza VS, Paro FM, Gomes DCAP, Toledo MLSA, Pedreira AB, Duarte H, Wittmer VL, Moulim MCB. Safety and Feasibility of Intradialytic Exercise Including Upper Limb Neuromuscular Electrical Stimulation in Adults With Chronic Kidney Disease: A Randomized Controlled Pilot Clinical Trial. Artif Organs. 2025 Aug 13. doi: 10.1111/aor.70006. Online ahead of print.

  PMID: 40799154 DERIVED

Related Links

• A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index).
• Translation and cross-cultural adaptation of the Duke Activity Status Index to Brazilian Portuguese.
• Tradução e adaptação cultural do instrumento de avaliação de qualidade de vida para pacientes renais crônicos (KDCOL-SFTM).
• Development of the kidney disease quality of life (KDQOL) instrument.
• Brazilian Dialysis Census: analysis of data from the 2009-2018 decade.
• Efeito da estimulação elétrica neuromuscular na força muscular, capacidade funcional e composição corporal em pacientes em hemodiálise.
• A carga global da doença renal crônica.
• Diretrizes de Prática Clínica para o Manejo da Pressão Arterial na Doença Renal Crônica

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Marcela c Barbalho, PhD

  Federal University of Espírito Santo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcela C Barbalho, PhD

CONTACT

997649935; marcelacbarbalho@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 16, 2022
• Study Start: August 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)