Chronic Kidney Disease (Stages 4 and 5), Hemodialysis, Inspiratory Muscle Training
Conditions
Keywords
hemodialysis, respiratory muscles, muscle strength, rehabilitation, functional capacity
Brief summary
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.
Detailed description
Individuals receiving regular hemodialysis may experience reduced inspiratory muscle strength, impaired lung function, dyspnea, reduced functional capacity, decreased daily physical activity, and changes in body composition. This single-center, open-label, randomized controlled study will evaluate the effect of intradialytic inspiratory muscle training on inspiratory muscle strength and related clinical and functional outcomes. All participants will first complete a 12-week observational period without study-protocolized inspiratory muscle training. Following the T0 assessment, participants will be randomly assigned in a 1:1 ratio to inspiratory muscle training plus usual care or usual care alone for 12 weeks. Participants assigned to inspiratory muscle training will perform training during hemodialysis using the POWERbreathe KH2 device. After the Week 12 assessment, participants initially assigned to inspiratory muscle training will undergo a second independent 1:1 randomization to either weekly maintenance inspiratory muscle training or discontinuation of study-protocolized training for 12 weeks. Participants initially assigned to usual care will continue usual care. Following the Week 24 assessment, no participant will receive study-protocolized inspiratory muscle training for 12 weeks. Follow-up assessments will be conducted through Week 52 after the initial randomization. The primary comparison is between inspiratory muscle training plus usual care and usual care alone at Week 12. Analyses of the second randomization and later follow-up assessments are exploratory.
Interventions
BEHAVIORALInspiratory Muscle Training
Intradialytic 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.
OTHERUsual Care
Usual 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.
Sponsors
Tecsam - Tecnologia e Servicos Medicos
Universidad de León
Instituto Politécnico de Bragança
Foundation for Science and Technology, Portugal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This is an open-label study. Participants, the principal investigator, care providers, and outcome assessors are not masked to intervention assignment.
Intervention model description
Following a 12-week observational period without study-protocolized inspiratory muscle training, participants will be randomized in a 1:1 ratio to inspiratory muscle training plus usual care or usual care alone for 12 weeks. After the Week 12 assessment, participants initially assigned to inspiratory muscle training will undergo a second independent 1:1 randomization to weekly maintenance inspiratory muscle training or discontinuation of study-protocolized training for 12 weeks. Participants initially assigned to usual care will continue usual care. All participants will subsequently undergo 12 weeks without study-protocolized inspiratory muscle training and follow-up through Week 52 after initial randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Able to provide written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Inspiratory Pressure From Baseline to Week 12 | Baseline at T0 and post-intervention at 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Borg Dyspnea Scale Score From Baseline to Week 12 | Baseline at T0 and post-intervention at 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. |
| Change in Dominant-Hand Handgrip Strength From Baseline to Week 12 | Baseline at T0 and post-intervention at 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. |
| Change in Body Composition From Baseline to Week 12 | Baseline at T0 and post-intervention at 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. |
| Change in KDQOL-SF 1.3 Health-Related Quality-of-Life Scores From Baseline to Week 12 | Baseline at T0 and post-intervention at 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. |
| Change in Forced Vital Capacity From Baseline to Week 12 | Baseline at T0 and post-intervention at Week 12 | Forced vital capacity will be measured by spirometry using the MIR Spirolab device with the participant seated with back support. The outcome is the change in forced vital capacity, expressed in liters and, when available, as a percentage of the predicted value. |
| Change in Surface Electromyography Root Mean Square Amplitude of Inspiratory Muscles From Baseline to Week 12 | Baseline at T0 and post-intervention at Week 12 | Surface electromyography will assess electrical activity of the scalene, sternocleidomastoid, intercostal, and diaphragm muscles using the Sessantaquattro+ system. Electromyographic signal amplitude will be quantified as root mean square amplitude and analyzed separately for each assessed muscle. |
| Change in Average Daily Steps From Baseline to Week 12 | Baseline at T0 and post-intervention at Week 12 | Daily physical activity will be assessed using a Garmin Forerunner 55 watch worn for seven consecutive days during each assessment period. The primary variable is the average number of steps per day, calculated from valid monitoring days. An assessment period requires at least four valid monitoring days. |
| Change in Forced Expiratory Volume in 1 Second From Baseline to Week 12 | Baseline at T0 and post-intervention at Week 12 | Forced expiratory volume in 1 second will be measured by spirometry using the MIR Spirolab device with the participant seated with back support. The outcome is the change in forced expiratory volume in 1 second, expressed in liters and, when available, as a percentage of the predicted value. |
| Change in 6-Minute Walk Test Distance From Baseline to Week 12 | Baseline at T0 and post-intervention at Week 12 | Functional capacity will be assessed by the distance covered during the 6-Minute Walk Test on a flat, straight 30-meter corridor. The outcome is the change in total walking distance, expressed in meters. Higher values indicate greater functional capacity. Participants may use their usual walking aid when routinely used in daily activities. |
Countries
Portugal
Contacts
CONTACTSónia Alexandra Claro Casado
CONTACTAndré Filipe Morais Pinto Novo
PRINCIPAL_INVESTIGATORAndré Filipe Morais Pinto Novo
Instituto Politécnico de Bragança
Outcome results
None listed