Chronic Renal DiseasesNCT05374863
Intradialytic Physiotherapy in Patients With Chronic Kidney Disease
A study testing Neuromuscular electrical stimulation (NMES) - Active and Aerobic exercise with cycle ergometer in people with Chronic Renal Diseases, run by Marcela Cangussu Barbalho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Diseases
- What is being tested?
- Neuromuscular electrical stimulation (NMES) - Active and Aerobic exercise with cycle ergometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presents symptoms and/or health conditions (cardiovascular, respiratory, neurological, cognitive) that prevent the performance of evaluation tests and participation in the exercise program.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Espírito Santo
Vitória, Espírito Santo, 29075-910
Marcela C Barbalho, PhD, 997649935 ext. 27, marcelacbarbalho@hotmail.com
About this study
Official title: Evaluation and Intervention of Intradialytic Physical Therapy in Patients With Chronic Kidney Disease: a Randomized Clinical Trial Protocol
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.
Read the 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.
- Conditions
- Chronic Renal Diseases
- Being tested
- Neuromuscular electrical stimulation (NMES) - Active, Neuromuscular Electrical Stimulation (NMES) - Sham, Aerobic exercise with cycle ergometer
- Keywords
- Chronic kidney disease, Hemodialisis, Exercise, Neuromuscular electrical stimulation
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulation (NMES) - ActiveDevice
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.
Neuromuscular Electrical Stimulation (NMES) - ShamDevice
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.
Aerobic exercise with cycle ergometerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Neuromuscular Electrical Stimulation (NMES) - Sham; Device: Aerobic exercise with cycle ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, pre-intervention/immediately after intervention.
Secondary outcomes (2)
Improved Cardiorespiratory capacity
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.
Measured: Baseline, pre-intervention/immediately after intervention.
Improved Capacity of life.
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.
Measured: Baseline, pre-intervention/immediately after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start1 Aug 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a controlled, randomized, double-blind clinical trial with an intention-to-treat analysis.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marcela Cangussu Barbalho
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitário Cassiano Antônio Moraes
- Responsible party
- Sponsor-investigator, Marcela Cangussu Barbalho, Federal University of Espirito Santo
- Investigators
- Marcela c Barbalho, PhD, Principal investigator, Federal University of Espírito Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374863
- Sponsor's protocol ID
- 27067819.1.0000.5071
- Status last verified
- Feb 2023
- First submitted
- 12 Apr 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Dec;49(12):1745-1755. doi: 10.1111/aor.70006. Epub 2025 Aug 13.
PubMed 40799154
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Intervention of Intradialytic Physical Therapy in Patients With Chronic Kidney Disease: a Randomized Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT05374863
- Acronym / sponsor ID
- 27067819.1.0000.5071
- Conditions
- Chronic Renal Diseases
- Keywords
- Chronic kidney disease, Hemodialisis, Exercise, Neuromuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marcela Cangussu BarbalhoUniversity, hospital or other
- Collaborators
- Hospital Universitário Cassiano Antônio Moraes
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a controlled, randomized, double-blind clinical trial with an intention-to-treat analysis.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Neuromuscular electrical stimulation (NMES) - Active, Device: Aerobic exercise with cycle ergometerNeuromuscular electrical stimulation (NMES) active in the upper limbs for 20 minutes and aerobic exercises on the cycle ergometer for 30 minutes. |
| Control Group | Placebo comparator | Device: Neuromuscular Electrical Stimulation (NMES) - Sham, Device: Aerobic exercise with cycle ergometerNMES-Sham in upper limbs for 20 minutes and aerobic exercises on a cycle ergometer for 30 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (1 listed)
- Presents symptoms and/or health conditions (cardiovascular, respiratory, neurological, cognitive) that prevent the performance of evaluation tests and participation in the exercise program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulation (NMES) - ActiveThe 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. | Device | Experimental Group |
| Neuromuscular Electrical Stimulation (NMES) - ShamIt will be performed in the same way as in the experimental group, however, the intensity of the actuality will only reach the sensitive threshold. | Device | Control Group |
| Aerobic exercise with cycle ergometerThe 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. | Device | Control Group, Experimental Group |
Primary outcome
Improved Functional Capacity
Time frame: 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
Time frame: 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.
2 secondary outcomes
Improved Cardiorespiratory capacity
Time frame: Baseline, pre-intervention/immediately after intervention.
Improved Capacity of life.
Time frame: Baseline, pre-intervention/immediately after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 40799154Rosa 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 Dec;49(12):1745-1755. doi: 10.1111/aor.70006. Epub 2025 Aug 13.
- A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index).Link provided by the sponsor.
- Translation and cross-cultural adaptation of the Duke Activity Status Index to Brazilian Portuguese.Link provided by the sponsor.
- Tradução e adaptação cultural do instrumento de avaliação de qualidade de vida para pacientes renais crônicos (KDCOL-SFTM).Link provided by the sponsor.
- Development of the kidney disease quality of life (KDQOL) instrument.Link provided by the sponsor.
- Brazilian Dialysis Census: analysis of data from the 2009-2018 decade.Link provided by the sponsor.
- Efeito da estimulação elétrica neuromuscular na força muscular, capacidade funcional e composição corporal em pacientes em hemodiálise.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcela c Barbalho, PhD principal investigator
Federal University of Espírito Santo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation (NMES) - Active and Aerobic exercise with cycle ergometer in people with Chronic Renal Diseases, run by Marcela Cangussu Barbalho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcela C Barbalho, PhD (997649935 ext. 27, marcelacbarbalho@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved Functional Capacity (time frame: Baseline, pre-intervention/immediately after intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.