Inspiratory Muscle Training During Hemodialysis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTecsam - Tecnologia e Servicos Medicos
About this trial
This study will evaluate whether inspiratory muscle training performed during hemodialysis improves inspiratory muscle strength in adults receiving regular hemodialysis. After an initial 12-week period without study-protocolized inspiratory muscle training, participants will be randomly assigned to inspiratory muscle training plus usual care or usual care alone for 12 weeks. The primary outcome is the change in maximum inspiratory pressure from baseline to Week 12. The study will also assess lung function, walking capacity, handgrip strength, electrical activity of inspiratory muscles, dyspnea, body composition, health-related quality of life, and daily physical activity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Enrolled in a regular hemodialysis program for at least 3 months
Receiving hemodialysis three times per week
Able to understand study information
Disqualifiers
Recent history of clinically significant cardiac arrhythmia, acute myocardial infarction, unstable angina, severe valvular disease, or uncontrolled hypertension
Medical condition that contraindicates an increase in intrathoracic negative pressure or performance of inspiratory muscle training
Uncontrolled acute or decompensated medical condition that compromises participant safety or the validity of the assessments
Severe cognitive impairment that prevents provision of informed consent or completion of study procedures
Trial design
Design model
Parallel
Treatments tested in this trial
Inspiratory Muscle Training
BehavioralIntradialytic inspiratory muscle training will be performed using the POWERbreathe KH2 electronic device. Training will begin approximately 30 minutes after the start of the hemodialysis session after confirmation of clinical and hemodynamic stability. Participants will be seated in the hemodialysis chair with the backrest raised to at least 45 degrees. The initial program will be performed three times weekly for 12 weeks, for a total of 36 planned sessions. Each session will include three sets of 30 inhalations against a resistance corresponding to 50 percent of maximum inspiratory pressure, with a two-minute rest between sets. Maximum inspiratory pressure will be reassessed after every six completed sessions, and resistance will be adjusted to 50 percent of the newly measured value. Training will be interrupted for chest pain, intolerable dyspnea, desaturation, hypotension, arrhythmia, intolerable fatigue, participant request, or any sign or symptom raising clinical concern.
Usual Care
Other interventionUsual care consists of the regular hemodialysis schedule and the clinical and nursing care routinely provided by the hemodialysis unit. No study-protocolized inspiratory muscle training will be administered.
Treatment groups
53 Participants
are divided into 2 treatment groupsGroup A: Group A: Inspiratory Muscle Training Plus Usual CareExperimental treatment 2 interventions
Group B: Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Maximum Inspiratory Pressure From Baseline to Week 12
Maximum inspiratory pressure will be measured using the POWERbreathe KH2 device with the participant seated with back support before the second or third weekly hemodialysis session. The outcome is the change in maximum inspiratory pressure, expressed in cmH2O.
Time frame
Baseline at T0 and post-intervention at Week 12Secondary outcomes
1
Change in Modified Borg Dyspnea Scale Score From Baseline to Week 12
Dyspnea will be assessed using the Modified Borg Dyspnea Scale, with scores ranging from 0 to 10, at rest and after the 6-Minute Walk Test. Higher scores indicate greater perceived dyspnea. The outcome is the change in Modified Borg Dyspnea Scale score.
Time frame
Baseline at T0 and post-intervention at Week 122
Change in Dominant-Hand Handgrip Strength From Baseline to Week 12
Handgrip strength will be assessed using the GripWise dynamometer with the participant seated with back support. Three attempts will be performed for each hand. The highest value obtained for the dominant hand, expressed in kilograms, will be used as the primary handgrip variable.
Time frame
Baseline at T0 and post-intervention at Week 123
Change in Body Composition From Baseline to Week 12
Body composition will be assessed by bioimpedance using the InBody BWA 2.0 device at the end of the second or third weekly hemodialysis session. Outcomes are changes in fat-free mass, expressed in kilograms; skeletal muscle mass, expressed in kilograms; and fat mass, expressed as a percentage.
Time frame
Baseline at T0 and post-intervention at Week 124
Change in KDQOL-SF 1.3 Health-Related Quality-of-Life Scores From Baseline to Week 12
Health-related quality of life will be assessed using the Kidney Disease Quality of Life Short Form, version 1.3 (KDQOL-SF 1.3). Scores will be calculated according to the instrument scoring instructions and converted to a 0 to 100 scale. Physical and mental summary measures derived from the SF-36 will be prioritized. Higher scores indicate better health-related quality of life in the respective domain.
Time frame
Baseline at T0 and post-intervention at Week 12Sponsors and contacts
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Tecsam - Tecnologia e Servicos Medicos
Lead sponsor
Universidad de León
Collaborator
Instituto Politécnico de Bragança
Collaborator
Foundation for Science and Technology, Portugal
Collaborator
Source ClinicalTrials.gov
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