Chronic Kidney DiseasesIAECKDNCT06055283
Effects of Intradialytic Aerobic Exercise in Chronic Kidney Patients
A study testing Aerobic exercise in people with Chronic Kidney Diseases, run by University of the State of Santa Catarina.
Trial summary
The goal of this clinical trial is to evaluate the effects of intradialytic aerobic exercise on muscle capacity, functionality and motivation of patients with chronic kidney disease undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of chronic kidney disease undergoing renal replacement therapy via hemodialysis
- aged 20 to 65 years
- low body mass index at overweight (21 kg/m2 to 29.9 kg/m2)
- regular renal replacement therapy via hemodialysis for 6 months, without acute complications related to the diagnosis and/or comorbidities for the period of 3 months prior to the evaluation and intervention.
Who cannot join
- patients who do not reach a score equal to or above 20 assessed by the Mini Mental State Examination
- severe heart failure according to the New York Heart Association classification
- musculoskeletal alteration that prevents the correct execution of the assessment activities
- who have participated in other exercise protocols in the last 6 months prior to the present study
- patients who show signs of clinical instability during the hemodialysis procedure or after training for two consecutive sessions will be excluded throughout the protocol.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Intradialytic Aerobic Exercise on Peripheral Muscle Function, Functional Status and Motivation in Chronic Kidney Patients: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to evaluate the effects of intradialytic aerobic exercise on muscle capacity, functionality and motivation of patients with chronic kidney disease undergoing hemodialysis.
The main question it aims to answer are:
- Is intradialytic aerobic exercise at moderate intensity effective in improving peripheral muscle function, functional status and motivation in patients with chronic kidney disease?
Read the detailed description
The progressive and irreversible advance of chronic kidney disease generates the systemic involvement of the organism and, consequently, the impairment of functionality and quality of life. Hemodialysis therapy is a strategy to increase survival and its long implementation time appears as a space for physiotherapeutic interventions in delaying functional impairment in these individuals. The objective will be to evaluate the effects of intradialytic aerobic exercise on muscle capacity, functionality and motivation of patients with chronic kidney disease undergoing hemodialysis. Patients with chronic kidney disease who undergo hemodialysis at TR São José - Clínica de hemodialysis LTDA (São José/SC) will be evaluated. Patients will be randomized, via a convenience sample, into two groups: intradialytic aerobic exercise group and control group. Interventions will take place within the first two hours of hemodialysis, using a portable cycle ergometer. Intensity will be controlled by heart rate and BORG Perceived Exertion Index. The training, for both groups, will be three times a week, for a period of three months. The aerobic exercise intensity will be moderate, in the percentage of maximum heart rate from 55 to 74% and BORG 4 to 6. A portable cycle ergometer will be used. The evaluations will be in the baseline period, after each complete month and after six months of the end. There will be three days of assessments at the hemodialysis clinic prior to renal replacement therapy and seven days using a home device, following the sequence: baseline blood sample collection, anthropometric assessment, vital signs, BORG, spirometry, mean quadriceps thickness, capacity functional status (six-minute step test), cognitive status (Montreal Cognitive Assessment-BR), quality of life (Kidney Disease And Quality-Of-Life Short Form), sleep quality (Pittsburgh Sleep Quality Index), state motivational (Behavior Regulation Exercise Questionnaire - BREQ3), muscle strength and endurance and daily physical activity. The sample calculation will be performed a posteriori, with Gpower software, based on the variables of the six-minute step test and muscle resistance value. Data will be systematized in the Statistical Package for Social Sciences version 20.0. Initially, descriptive statistics will be performed. To characterize the sample, the following variables will be considered: age, gender, anthropometric data, spirometric parameters, body composition, urea and creatinine clearance, cognitive status. Data distribution will be evaluated using the Shapiro-Wilk test or a non-parametric analogue. To compare the response of the outcome variables between the groups, the ANOVA two-way test of repeated measures, or a non-parametric analogue, will be used. To verify relationships between numeric variables, Pearson's correlation coefficient or non-parametric analogue will be used. The significance level adopted for the statistical treatment will be 5% (p < 0.05).
- Conditions
- Chronic Kidney Diseases
- Being tested
- Aerobic exercise
- Keywords
- Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
The training group will receive aerobic exercise and the intensities will be controlled considering the percentage of estimated maximum heart rate. The training will be performed with a cycle ergometer with a total of 40 minutes of intradialytic aerobic exercise in the training group. To reduce the effects of intolerance to aerobic exercise, a week of adaptation will be performed, with a frequency of three sessions, in the first two hours of hemodialysis, lasting 40 minutes at maximum heart rate intensity of up to 74% and BORG up to 4 (low intensity). Afterwards, the patients will perform the prediction training for 12 weeks, at the frequency of three training sessions per week in the first two hours of hemodialysis. Each training session will start with a 5-minute warm-up at low intensity, 30 minutes of main training with maximum heart rate intensity 55% to 74% and BORG 5 to 7 (moderate intensity) and will end with a 5-minute cool-down at low intensity.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Aerobic exercise training on moderate intensity. Receives: Other: Aerobic exercise |
| Control group | No intervention | Monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
six minute step test
A step 20 centimeters high will be used and the patient will be instructed to go up and down it as many times during the 6 minutes, according to free cadence and will be instructed not to use the upper limbs
Measured: 12 weeks
Secondary outcomes (9)
muscle strength
measured by dynamometry, the records will be in newtons.
Measured: 12 weeks
Daily life physical activity
number of steps for seven days by triaxial accelerometer
Measured: 12 weeks
Behavior Regulation Questionnaire for Physical Exercise
The questionnaire ranges from 0 to 24 for self-regulation indices and 0 to 4 for each type of regulation, namely external, introjected, identified, integrated and intrinsic regulation
Measured: 12 weeks
index of self-determination and basic psychological needs
The score varies from 1 to 5, with 1 being total disagreement and 5 total agreement for variables related to the link between competence and autonomy.
Measured: 12 weeks
Pittsburg Sleep Quality Index
The questionnaire quantifies sleep quality, calculated between seven skills. The final result varies from good sleep quality (0-4), poor sleep quality (5-10) and the presence of sleep disorders (above 10).
Measured: 12 weeks
Montreal Cognitive Assessment
8 cognitive domains (visual-spatial execution, naming, memory, attention, language, abstraction, delayed recall and orientation), with a score from 0 to 30. The cut-off point for renal hemodialysis patients is less than or equal to 24, and the the higher the score, the better the vascular cognitive function
Measured: 12 weeks
blood sample
The analyzes carried out will be regarding the marker of muscle trophism (insulin-like growth factor type 1), pro-inflammatory cytokines (tumor necrosis factor - TNF-alpha) and anti-inflammatory cytokines (interleukin 10 - IL-10).
Measured: 12 weeks
lower limb resistance
Measured by dynamometry, the records will be in tolerated seconds.
Measured: 12 weeks
Kidney Disease and Quality-of-Life - Short Form
eight dimensions, ten items for physical functioning, four items for limitations caused by physical health problems, three items for limitations caused by emotional health problems, two items for social functioning, five items for mental health, two items for pain, four items for vitality, energy and fatigue, five items for perceptions of general health and one item for current health status compared to a year ago, which is computed separately.The degree of commitment is measured using values ranging from zero (highest degree of commitment) to 100 (no commitment). Therefore, the higher the score obtained, the better the quality of life.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study startNov 2023 (estimated)
- Primary completion14 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jéssica Canizelli Gonçalez, University of the State of Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055283
- Sponsor's protocol ID
- ECRC/CKD
- Acronym
- IAECKD
- Status last verified
- Sep 2023
- First submitted
- 5 Jun 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intradialytic Aerobic Exercise on Peripheral Muscle Function, Functional Status and Motivation in Chronic Kidney Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06055283
- Acronym / sponsor ID
- IAECKD / ECRC/CKD
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- 14 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Sep 2023 (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 goal of this clinical trial is to evaluate the effects of intradialytic aerobic exercise on muscle capacity, functionality and motivation of patients with chronic kidney disease undergoing hemodialysis.
The main question it aims to answer are:
- Is intradialytic aerobic exercise at moderate intensity effective in improving peripheral muscle function, functional status and motivation in patients with chronic kidney disease?
Detailed description
The progressive and irreversible advance of chronic kidney disease generates the systemic involvement of the organism and, consequently, the impairment of functionality and quality of life. Hemodialysis therapy is a strategy to increase survival and its long implementation time appears as a space for physiotherapeutic interventions in delaying functional impairment in these individuals. The objective will be to evaluate the effects of intradialytic aerobic exercise on muscle capacity, functionality and motivation of patients with chronic kidney disease undergoing hemodialysis. Patients with chronic kidney disease who undergo hemodialysis at TR São José - Clínica de hemodialysis LTDA (São José/SC) will be evaluated. Patients will be randomized, via a convenience sample, into two groups: intradialytic aerobic exercise group and control group. Interventions will take place within the first two hours of hemodialysis, using a portable cycle ergometer. Intensity will be controlled by heart rate and BORG Perceived Exertion Index. The training, for both groups, will be three times a week, for a period of three months. The aerobic exercise intensity will be moderate, in the percentage of maximum heart rate from 55 to 74% and BORG 4 to 6. A portable cycle ergometer will be used. The evaluations will be in the baseline period, after each complete month and after six months of the end. There will be three days of assessments at the hemodialysis clinic prior to renal replacement therapy and seven days using a home device, following the sequence: baseline blood sample collection, anthropometric assessment, vital signs, BORG, spirometry, mean quadriceps thickness, capacity functional status (six-minute step test), cognitive status (Montreal Cognitive Assessment-BR), quality of life (Kidney Disease And Quality-Of-Life Short Form), sleep quality (Pittsburgh Sleep Quality Index), state motivational (Behavior Regulation Exercise Questionnaire - BREQ3), muscle strength and endurance and daily physical activity. The sample calculation will be performed a posteriori, with Gpower software, based on the variables of the six-minute step test and muscle resistance value. Data will be systematized in the Statistical Package for Social Sciences version 20.0. Initially, descriptive statistics will be performed. To characterize the sample, the following variables will be considered: age, gender, anthropometric data, spirometric parameters, body composition, urea and creatinine clearance, cognitive status. Data distribution will be evaluated using the Shapiro-Wilk test or a non-parametric analogue. To compare the response of the outcome variables between the groups, the ANOVA two-way test of repeated measures, or a non-parametric analogue, will be used. To verify relationships between numeric variables, Pearson's correlation coefficient or non-parametric analogue will be used. The significance level adopted for the statistical treatment will be 5% (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Aerobic exerciseAerobic exercise training on moderate intensity. |
| Control group | No intervention | –Monitoring. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of chronic kidney disease undergoing renal replacement therapy via hemodialysis
- aged 20 to 65 years
- low body mass index at overweight (21 kg/m2 to 29.9 kg/m2)
- regular renal replacement therapy via hemodialysis for 6 months, without acute complications related to the diagnosis and/or comorbidities for the period of 3 months prior to the evaluation and intervention.
Key exclusion criteria (5 listed)
- patients who do not reach a score equal to or above 20 assessed by the Mini Mental State Examination
- severe heart failure according to the New York Heart Association classification
- musculoskeletal alteration that prevents the correct execution of the assessment activities
- who have participated in other exercise protocols in the last 6 months prior to the present study
- patients who show signs of clinical instability during the hemodialysis procedure or after training for two consecutive sessions will be excluded throughout the protocol.
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 |
|---|---|---|
| Aerobic exerciseThe training group will receive aerobic exercise and the intensities will be controlled considering the percentage of estimated maximum heart rate. The training will be performed with a cycle ergometer with a total of 40 minutes of intradialytic aerobic exercise in the training group. To reduce the effects of intolerance to aerobic exercise, a week of adaptation will be performed, with a frequency of three sessions, in the first two hours of hemodialysis, lasting 40 minutes at maximum heart rate intensity of up to 74% and BORG up to 4 (low intensity). Afterwards, the patients will perform the prediction training for 12 weeks, at the frequency of three training sessions per week in the first two hours of hemodialysis. Each training session will start with a 5-minute warm-up at low intensity, 30 minutes of main training with maximum heart rate intensity 55% to 74% and BORG 5 to 7 (moderate intensity) and will end with a 5-minute cool-down at low intensity. | Other | Training group |
Primary outcome
six minute step test
Time frame: 12 weeks
A step 20 centimeters high will be used and the patient will be instructed to go up and down it as many times during the 6 minutes, according to free cadence and will be instructed not to use the upper limbs
9 secondary outcomes
muscle strength
Time frame: 12 weeks
Daily life physical activity
Time frame: 12 weeks
Behavior Regulation Questionnaire for Physical Exercise
Time frame: 12 weeks
index of self-determination and basic psychological needs
Time frame: 12 weeks
Pittsburg Sleep Quality Index
Time frame: 12 weeks
Montreal Cognitive Assessment
Time frame: 12 weeks
blood sample
Time frame: 12 weeks
lower limb resistance
Time frame: 12 weeks
Kidney Disease and Quality-of-Life - Short Form
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Chronic Kidney Diseases, run by University of the State of Santa Catarina.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jéssica Canizelli Gonçalez, Ms (47996087774 ext. +55, jessicacgoncalez@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six minute step test (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2023.