Efficacy of Combined Low- and High- Frequency Stimulation in Peripheral Muscle Function During Hemodialysis

NCT03779126 | Unknown DMC

• 1 other identifier: HSL 2017-95
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic kidney disease is a systemic disease that affects not only renal function, but also, several organs, bringing social, psychological and physical impact to the patients under this condition. Due to long periods of inactivity during hemodialysis, electrical stimulation becomes a feasible alternative for development physical activity in these patients. Objective: Assess the efficacy of combined low and high frequency electrical stimulation in peripheral muscle function during hemodialysis. Methods: A randomised double-blind clinical trial with chronic kidney disease patient's under hemodialysis, whose will be allocated in four groups: low frequency electrical stimulation (LF) ; high frequency (HF); low and high frequency (LHF); and sham electrical stimulation. The groups will receive quadriceps application bilaterally, for sixty minutes, three times a week, for two months. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current. The individuals will be evaluated for anthropometry, functional capacity, quality of life and biochemical parameters.

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease; Electrical stimulation

Outcome Measures

Primary Outcomes (3)

• Assess the improvement of muscle mass

  The muscle mass will be assessed by electric bioimpedance

  Eight weeks

• Assess the improvement of muscle strength

  The muscle strength will be assessed using isokinetic by peak torque

  Eight weeks

• Assess the improvement of muscle resistance

  The muscle resistance will be assessed using isokinetic by fatigue index

  Eight weeks

Secondary Outcomes (7)

• Assess the improvement of intervention in quality of life

  Eight weeks

• Correlate peripheral muscle function using medical research council score with nutritional status

  Eight weeks

• Correlate peripheral muscle function using hand grip with nutritional status

  Eight weeks

• Correlate peripheral muscle function with body composition

  Eight weeks

• Correlate peripheral muscle function with functional capacity

  Eight weeks

Study Arms (4)

Active comparator

EXPERIMENTAL

Low frequency electrical stimulation for 60 minutes, three times a week during 60 days.

Device: Electrical stimulation

Other

EXPERIMENTAL

High frequency electrical stimulation for 60 minutes, three times a week during 60 days.

Device: Electrical stimulation

Experimental group

EXPERIMENTAL

Low and High frequency electrical stimulation for 60 minutes, three times a week during 60 days.

Device: Electrical stimulation

Placebo

PLACEBO COMPARATOR

Placebo electrical stimulation for 60 minutes, three times a week during 60 days. In the intervention groups will be used highest intensity tolerated by the individual, and in the sham will be maintained the minimum intensity after beginning of the perception of the electric current

Device: Electrical stimulation

Interventions

Electrical stimulation DEVICE

1\) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.

Also known as: Low frequency electrical stimulation (LF), High frequency (HF), Low and High frequency (LHF), sham stimulation

Active comparator; Experimental group; Other; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic kidney disease
• Classical hemodialysis
• Over 18 years old
• No pace maker
• Without cognitive or motor deficit
• No regular physical activity in the last six months

You may not qualify if:

• Abstention for more than two consecutive sessions or four in total
• Inability to perform the tests

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Hospitalsiriolibanes

São Paulo, 01308-050, Brazil

RECRUITING

Related Publications (24)

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  PMID: 21848929 RESULT

• de Souza Francisco D, Moraes IG, Brito CP, Righetti RF, Yamaguti WP. The phase angle cut-off point capable of discriminating hemodialysis patients with reduced exercise tolerance: a cross-sectional study. BMC Sports Sci Med Rehabil. 2024 Feb 2;16(1):34. doi: 10.1186/s13102-024-00825-5.

  PMID: 38308310 DERIVED

• Moraes IG, Brito CP, Francisco DS, Faria LM, Luders C, de Brito CMM, Yamaguti WP. Efficacy of neuromuscular electrical stimulation with combined low and high frequencies on body composition, peripheral muscle function and exercise tolerance in patients with chronic kidney disease undergoing haemodialysis: a protocol for a randomised, double-blind clinical trial. BMJ Open. 2022 Nov 9;12(11):e062062. doi: 10.1136/bmjopen-2022-062062.

  PMID: 36351736 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Electric Stimulation

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

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Wellington PS Yamaguti, Phd

  Hospital Sírio-Libanês

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wellington PS Yamaguti, Phd

CONTACT

1133940200; wellington.psyamaguti@hsl.org.br

Igor G Moraes, Ms

CONTACT

1133940200; igor.gmoraes@hsl.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The assessments will be conducted for a second investigator to ensure the blinding of first investigator. The subjects will be randomised in four groups (low frequency, high frequency, low and high frequency and sham stimulation) to ensure the blinding of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wellington Pereira dos Santos Yamaguti

Model Details: The subjects will be randomised in four groups: 1) low frequency electrical stimulation (LF), 2) high frequency (HF), low and High frequency (LHF), and sham. The subjects will receive electrical stimulation in quadriceps bilaterally for 60 minutes , three times per week, during two months.

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: December 19, 2018
• Study Start: February 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)