An interventional study of POWERbreathe® Classic Light in Kidney Disease, sponsored by Universidade Federal de Pernambuco. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-11.
Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Treatment
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.
3,842 studies on the registry are indexed under Kidney Diseases; 492 are open to participants now.
This study's enrollment of 24 is below the median of 70 across 2,645 interventional studies indexed under Kidney Diseases.
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Will use the breathing coach POWERbreathe® Classic Light. Participants will hold the workout three sets of 30 inspirations, 2 sessions per day, 7 days per week for 8 weeks. The training group will carry with IMT load of 50% of MIP. Weekly, patients attend the Cardiopulmonary Physical Therapy Laboratory for evaluation of MIP and load adjustment, performing a training session in the presence of the therapist, while other sessions will be held by the participant at home and registered in the diary training. The training took place with the patient sitting in chair with a back, with knees and hips flexed to 90 °, the participant will use a nose clip and the device coupled to the nozzle mouth, will be instructed to diaphragmatic breathing pattern.
Device: POWERbreathe® Classic Light
Will use the breathing coach POWERbreathe® Classic Light. Participants will hold the workout three sets of 30 inspirations, 2 sessions per day, 7 days per week for 8 weeks. The sham group will carry without load, but will be subjected to the same procedures in the experimental group (simulation of load adjustment in the Cardiopulmonary Physical Therapy Laboratory) to ensure blinding of the study, other sessions will be held by the participant at home and registered in the diary training. The training took place with the patient sitting in chair with a back, with knees and hips flexed to 90 °, the participant will use a nose clip and the device coupled to the nozzle mouth, will be instructed to diaphragmatic breathing pattern.
Device: POWERbreathe® Classic Light
Inspiratory Muscle Training
Respiratory muscle strength
Evaluate by manometer
Time frame: 2 months
Diaphragm thickness
Evaluate by ultrasound
Time frame: 2 months
Chest wall volume
Evaluate by opto-electronic plethysmography
Time frame: 2 months
Pulmonary function
Evaluate by Spirometry
Time frame: 2 months
Walking distance
Evaluate by six-minute walk test
Time frame: 2 months
Quality of life
Evaluate by questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF
Time frame: 2 months
Diaphragm mobility
Evaluate by ultrasound
Time frame: 2 months
Plan to share: Undecided
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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