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Inspiratory Muscle Training in Patients With End-stage Renal Disease

Effectiveness of Inspiratory Muscle Training in Respiratory Muscle Strength, Chest Wall Volume, Diaphragm Thickness and Mobility in Patients With End-stage Renal Disease: Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02599987
Enrollment
24
Registered
2015-11-09
Start date
2015-11-30
Completion date
2016-12-31
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Disease

Brief summary

Background: Patients with chronic kidney disease on hemodialysis may have reduced diffusion capacity, lung function and gas exchange due to mechanical and hemodynamic changes in the respiratory system, and decreased respiratory muscle strength resulting from uremic myopathy. The inspiratory muscle training (IMT) appears as an instrument to improve the inspiratory muscle strength, with positive effects on functional capacity and quality of life of kidney patients, however, the effects of IMT were not addressed in the specific variables of the respiratory system and to date there are no studies on the use of daily training in this population. Objective: To evaluate the effectiveness of daily inspiratory muscle training on respiratory muscle strength, chest wall volume, diaphragm thickness and mobility of end-stage renal disease patients. Methods: A randomized controlled clinical trial to be developed in Cardiopulmonary Physical Therapy Laboratory of the Universidade Federal de Pernambuco (UFPE) during the period from November 2015 to December 2016. The sample is composed of 24 individuals aged 18 and 65, having CKD, to perform hemodialysis for at least twelve months and provide inspiratory muscle weakness. Patients will be divided into two groups, the training group will be IMT with POWER-breathe®, load of 50% of MIP, duration of three sets of 30 inspirations, frequency of two sessions per day, 7 days a week for 8 weeks, since the sham group will be subjected to the same procedure (duration and frequency), but without load. Participants will be assessed before and after intervention through a global assessment form, questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF, diaphragmatic ultrasound, opto-electronic plethysmography, spirometry, manometer and six-minute walk test.

Interventions

DEVICEPOWERbreathe® Classic Light

Inspiratory Muscle Training

Sponsors

Universidade Federal de Pernambuco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Have a chronic kidney disease * Hemodialysis for a minimum period of twelve months * Inspiratory muscle weakness, with MIP \<80cmH2O for men and \<60cmH2O for women

Exclusion criteria

* Neurological deficit * Chronic lung disease * Severe heart disease (unstable angina and acute myocardial infarction) * Decompensated diabetes * Infectious disease

Design outcomes

Primary

MeasureTime frameDescription
Respiratory muscle strength2 monthsEvaluate by manometer
Diaphragm thickness2 monthsEvaluate by ultrasound

Secondary

MeasureTime frameDescription
Walking distance2 monthsEvaluate by six-minute walk test
Chest wall volume2 monthsEvaluate by opto-electronic plethysmography
Diaphragm mobility2 monthsEvaluate by ultrasound
Quality of life2 monthsEvaluate by questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF
Pulmonary function2 monthsEvaluate by Spirometry

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026