Inspiratory Muscle Training During Hemodialysis

NCT07811947 | Not Yet Recruiting DMC

• 2 other identifiers: 10.54499/2024.17137.PEXP522771-R636876-D1882423
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease (Stages 4 and 5); Hemodialysis; Inspiratory Muscle Training

Keywords

hemodialysis; respiratory muscles; muscle strength; rehabilitation; functional capacity

Outcome Measures

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.

  Baseline at T0 and post-intervention at Week 12

Secondary Outcomes (9)

• Change in Modified Borg Dyspnea Scale Score From Baseline to Week 12

  Baseline at T0 and post-intervention at Week 12

• Change in Dominant-Hand Handgrip Strength From Baseline to Week 12

  Baseline at T0 and post-intervention at Week 12

• Change in Body Composition From Baseline to Week 12

  Baseline at T0 and post-intervention at Week 12

• 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

• Change in Forced Vital Capacity From Baseline to Week 12

  Baseline at T0 and post-intervention at Week 12

Study Arms (2)

Group A: Inspiratory Muscle Training Plus Usual Care

EXPERIMENTAL

From T0 to Week 12, participants will receive intradialytic inspiratory muscle training in addition to usual hemodialysis care. After the Week 12 assessment, participants initially assigned to Group A will undergo a second randomization to either weekly maintenance inspiratory muscle training or discontinuation of study-protocolized inspiratory muscle training.

Behavioral: Inspiratory Muscle Training; Other: Usual Care

Group B: Usual Care

ACTIVE COMPARATOR

Participants will continue regular hemodialysis and routine clinical and nursing care provided by the hemodialysis unit. They will not receive study-protocolized inspiratory muscle training during the study participation period.

Other: Usual Care

Interventions

Inspiratory Muscle Training BEHAVIORAL

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.

Group A: Inspiratory Muscle Training Plus Usual Care

Usual Care OTHER

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.

Group A: Inspiratory Muscle Training Plus Usual Care; Group B: Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tecsam - Tecnologia e Servicos Medicos: lead
• Universidad de León: collaborator
• Instituto Politécnico de Bragança: collaborator
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (1)

Tecsam - Tecnologia e Serviços Médicos

Mirandela, Braganza District, 5370-530, Portugal

Location

Related Publications (1)

• Casado SAC, Mendes MER, Preto LSR, Vila-Cha CJF, Novo AFMP. Effect of inspiratory muscle training in hemodialysis patients: a systematic review of randomized controlled trials. Disabil Rehabil. 2026 Mar;48(5):1205-1215. doi: 10.1080/09638288.2025.2554947. Epub 2025 Sep 3.

  PMID: 40901738 BACKGROUND

Related Links

• Official project page with study protocol details - Official project page containing the detailed study protocol for respiratory rehabilitation in hemodialysis patients, including objectives, methodology, and implementation plan.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• André Filipe Morais Pinto Novo

  Instituto Politécnico de Bragança

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sónia Alexandra Claro Casado

CONTACT

+351965364163; soniaaccasado@gmail.com

André Filipe Morais Pinto Novo

CONTACT

+351917972163; andre@ipb.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, the principal investigator, care providers, and outcome assessors are not masked to intervention assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rehabilitation Nurse

Model Details: 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

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: September 10, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): December 21, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)