Kidney Failure, ChronicNCT04660383
Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity
A study testing Inspiratory Muscle Training in people with Kidney Failure, Chronic, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Investigate the effects of Inspiratory Muscle Training (IMT) performed during hemodialysis (HD) procedures in patients with end stage kidney disease (ESKD). With intervention of thirty-six IMT sessions, performed three times a week, at an intensity of 50%, 30% and 10% (sham) of the maximum inspiratory pressure (MIP). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Inspiratory Muscle Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2022to Mar 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD patients who have been on HD for at least three months;
- In physical conditions to perform the tests proposed by the study;
- With stable CKD for at least 30 days (with no hospitalization);
Who cannot join
- Patients with a recent history of arrhythmias;
- Recent hospitalization (<3 months);
- Recent acute myocardial infarction (<6 weeks);
- HD routine less than 2X / week;
- Muscle or respiratory changes (eg, chronic obstructive pulmonary disease (COPD));
- Unstable angina;
Show all 11Show fewer
- Severe valve disease;
- Uncontrolled hypertension;
- Hemoglobin concentration <10 g / dL;
- Participation in a study with intradialytic exercise in the six months preceding this study;
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 91350-170
Marcelo Teixeira, Master, 51992665901, msteix@gmail.com
About this study
Official title: Effects of Intradialytic Inspiratory Muscle Training at Different Intensities on Diaphragm Hypertrophy and Functional Capacity in Patients Undergoing Hemodialysis: a Randomized Clinical Trial.
Investigate the effects of Inspiratory Muscle Training (IMT) performed during hemodialysis (HD) procedures in patients with end stage kidney disease (ESKD). With intervention of thirty-six IMT sessions, performed three times a week, at an intensity of 50%, 30% and 10% (sham) of the maximum inspiratory pressure (MIP).
Read the detailed description
Introduction: Chronic kidney disease (CKD), especially in its final stage (ESKD), is associated with an increased risk of cardiovascular complications and mortality. Part of this risk can be attributed to the fact that patients with ESKD adopt sedentary behavior.
Objectives: To investigate the effects of Inspiratory Muscle Training (IMT) performed during hemodialysis (HD) procedures in patients with ESKD.
Methodology: Randomized double-blind clinical trial, controlled by sham. Location: Nephrology Sector, Hospital de Clínicas de Porto Alegre (HCPA) Participants: three groups of 12 patients with ESKD on HD randomized to three IMT intensities.
Intervention: Thirty-six IMT sessions, performed three times a week, at an intensity of 50%, 30% and 10% (sham) of the maximum inspiratory pressure (Pimax).
Main outcomes: Functional capacity, diaphragm hypertrophy, respiratory muscle strength, lung volume, blood pressure and quality of life.
Statistical Analysis: Presentation of data in absolute and relative numbers, and through means and standard deviations. To compare the groups, ANOVA will be used, with significance less than 0.05.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Inspiratory Muscle Training
- Keywords
- intradialytic training, Inspiratory Muscle Training, Diaphragm Hypertrophy, Functional capacity, End Stage Kidney Disease
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingDevice
Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.
| Study group | Role | What they receive |
|---|---|---|
| IMT 50 | Experimental | IMT intervention: IMT50 - 50% of the maximum inspiratory pressure (MIP), using equipment "Threshold IMT®" or "Power Breathe®", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs. Receives: Device: Inspiratory Muscle Training |
| IMT 30 | Experimental | IMT intervention: IMT30 - 30% of the maximum inspiratory pressure, using equipment "Threshold IMT®" or "Power Breathe®", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs. Receives: Device: Inspiratory Muscle Training |
| IMT 10 | Sham comparator | IMT intervention: IMT10 - 10% of the maximum inspiratory pressure, using equipment "Threshold IMT®" or "Power Breathe®", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs. Receives: Device: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Capacity (6MWT)
The 6MWT is a useful, validated, and well-tolerated tool that requires no specialized equipment, used to determine the functional capacity of individuals with chronic kidney disease. 19 In addition, the 6MWT is able to represent the submaximal level of functional capacity (e.g., daily physical activity). The results will be defined as the difference in meters in distance covered at weeks 0 and 12. Participants will be instructed to walk on a flat, straight corridor, and will be told that the objective of the test is to walk as far as possible for six minutes at a self-selected speed.
Measured: Baseline, 3 months
Change in Functional Capacity (CPET)
Patients will be submitted to CPET on an exercise bike, using an incremental loading protocol according to the guidelines published by the American Thoracic Society / American College of Chest Physicians.
Measured: Baseline, 3 months
Change in diaphragm hypertrophy
Mode B ultrasound (EnVisor C, Philips, Bothell, Washington) with a 12.0 MHz ultrasound probe (L12-3, Philips) will be used for the image of the diaphragm in the apposition zone, the vertical section that rests against the lateral portion of the right rib cage, with the method described by Wait et al.
Measured: Baseline, 3 months
Secondary outcomes (3)
Change in ambulatory blood pressure measurement (ABPM)
ABPM is a method that allows indirect and intermittent blood pressure recordings for a period of 24 hours, while patients perform their daily life activities.
Measured: Baseline, 3 months
Change in respiratory muscle strength
Maximal Inspiratory Measure and Maximal Expiratory Measure: will be carried out by GlobalMed® MVD300 manovacuometry equipment.
Measured: Baseline, 3 months
Quality of Life assessed by KDQoL Short-Form
Assessed by Kidney Disease Quality of Life Short-Form
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study startDec 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionMar 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 Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Stein, PhD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660383
- Sponsor's protocol ID
- 2020-0458
- Status last verified
- Nov 2022
- First submitted
- 1 Dec 2020
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teixeira MS, Ferrari F, Dipp T, Carvalho G, Bitencourt EDS, Saffi M, Stein R. Effects of intradialytic inspiratory muscle training at different intensities on diaphragm thickness and functional capacity: clinical trial protocol in patients undergoing haemodialysis. BMJ Open. 2023 Jan 27;13(1):e066778. doi: 10.1136/bmjopen-2022-066778.
PubMed 36707111
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intradialytic Inspiratory Muscle Training at Different Intensities on Diaphragm Hypertrophy and Functional Capacity in Patients Undergoing Hemodialysis: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04660383
- Acronym / sponsor ID
- 2020-0458
- Conditions
- Kidney Failure, Chronic
- Keywords
- intradialytic training, Inspiratory Muscle Training, Diaphragm Hypertrophy, Functional capacity, End Stage Kidney Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 9 Dec 2020 (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.
Investigate the effects of Inspiratory Muscle Training (IMT) performed during hemodialysis (HD) procedures in patients with end stage kidney disease (ESKD). With intervention of thirty-six IMT sessions, performed three times a week, at an intensity of 50%, 30% and 10% (sham) of the maximum inspiratory pressure (MIP).
Detailed description
Introduction: Chronic kidney disease (CKD), especially in its final stage (ESKD), is associated with an increased risk of cardiovascular complications and mortality. Part of this risk can be attributed to the fact that patients with ESKD adopt sedentary behavior.
Objectives: To investigate the effects of Inspiratory Muscle Training (IMT) performed during hemodialysis (HD) procedures in patients with ESKD.
Methodology: Randomized double-blind clinical trial, controlled by sham. Location: Nephrology Sector, Hospital de Clínicas de Porto Alegre (HCPA) Participants: three groups of 12 patients with ESKD on HD randomized to three IMT intensities.
Intervention: Thirty-six IMT sessions, performed three times a week, at an intensity of 50%, 30% and 10% (sham) of the maximum inspiratory pressure (Pimax).
Main outcomes: Functional capacity, diaphragm hypertrophy, respiratory muscle strength, lung volume, blood pressure and quality of life.
Statistical Analysis: Presentation of data in absolute and relative numbers, and through means and standard deviations. To compare the groups, ANOVA will be used, with significance less than 0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IMT 50 | Experimental | Device: Inspiratory Muscle TrainingIMT intervention: IMT50 - 50% of the maximum inspiratory pressure (MIP), using equipment "Threshold IMT®" or "Power Breathe®", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs. |
| IMT 30 | Experimental | Device: Inspiratory Muscle TrainingIMT intervention: IMT30 - 30% of the maximum inspiratory pressure, using equipment "Threshold IMT®" or "Power Breathe®", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs. |
| IMT 10 | Sham comparator | Device: Inspiratory Muscle TrainingIMT intervention: IMT10 - 10% of the maximum inspiratory pressure, using equipment "Threshold IMT®" or "Power Breathe®", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CKD patients who have been on HD for at least three months;
- In physical conditions to perform the tests proposed by the study;
- With stable CKD for at least 30 days (with no hospitalization);
Key exclusion criteria (11 listed)
- Patients with a recent history of arrhythmias;
- Recent hospitalization (<3 months);
- Recent acute myocardial infarction (<6 weeks);
- HD routine less than 2X / week;
- Muscle or respiratory changes (eg, chronic obstructive pulmonary disease (COPD));
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 |
|---|---|---|
| Inspiratory Muscle TrainingPatients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions. | Device | IMT 10, IMT 30, IMT 50 |
Primary outcome
Change in Functional Capacity (6MWT)
Time frame: Baseline, 3 months
The 6MWT is a useful, validated, and well-tolerated tool that requires no specialized equipment, used to determine the functional capacity of individuals with chronic kidney disease. 19 In addition, the 6MWT is able to represent the submaximal level of functional capacity (e.g., daily physical activity). The results will be defined as the difference in meters in distance covered at weeks 0 and 12. Participants will be instructed to walk on a flat, straight corridor, and will be told that the objective of the test is to walk as far as possible for six minutes at a self-selected speed.
Change in Functional Capacity (CPET)
Time frame: Baseline, 3 months
Patients will be submitted to CPET on an exercise bike, using an incremental loading protocol according to the guidelines published by the American Thoracic Society / American College of Chest Physicians.
Change in diaphragm hypertrophy
Time frame: Baseline, 3 months
Mode B ultrasound (EnVisor C, Philips, Bothell, Washington) with a 12.0 MHz ultrasound probe (L12-3, Philips) will be used for the image of the diaphragm in the apposition zone, the vertical section that rests against the lateral portion of the right rib cage, with the method described by Wait et al.
3 secondary outcomes
Change in ambulatory blood pressure measurement (ABPM)
Time frame: Baseline, 3 months
Change in respiratory muscle strength
Time frame: Baseline, 3 months
Quality of Life assessed by KDQoL Short-Form
Time frame: Baseline, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Derived from this study: PubMed 36707111Teixeira MS, Ferrari F, Dipp T, Carvalho G, Bitencourt EDS, Saffi M, Stein R. Effects of intradialytic inspiratory muscle training at different intensities on diaphragm thickness and functional capacity: clinical trial protocol in patients undergoing haemodialysis. BMJ Open. 2023 Jan 27;13(1):e066778. doi: 10.1136/bmjopen-2022-066778.
- 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.
Ricardo Stein, PhD study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Kidney Failure, Chronic, run by Hospital de Clinicas de Porto Alegre 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 3 inclusion and 11 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 22 Nov 2022. 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 Marcelo Teixeira, Master (+55 51 992665901, msteix@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Capacity (6MWT) (time frame: Baseline, 3 months). The study lists 3 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 NCT04660383, 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 22 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.