Ignite Creation Date:
2024-05-06 @ 7:45 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02599987
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2015-11-04
Brief Title:
Inspiratory Muscle Training in Patients With End-stage Renal Disease
Sponsor:
Universidade Federal de Pernambuco
Organization:
Universidade Federal de Pernambuco
Study Overview
Official Title:
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
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None