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Completed

NCT Number: NCT02599987

Inspiratory Muscle Training in Patients With End-stage Renal Disease

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiopulmonary Physiotherapy Laboratory of UFPE

Recife, Pernambuco, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

POWERbreathe® Classic Light

Device

Inspiratory Muscle Training

Primary outcomes

  1. Respiratory muscle strength

    Time frame: 2 months

    Evaluate by manometer

  2. Diaphragm thickness

    Time frame: 2 months

    Evaluate by ultrasound

Secondary outcomes

  1. Chest wall volume

    Time frame: 2 months

    Evaluate by opto-electronic plethysmography

  2. Pulmonary function

    Time frame: 2 months

    Evaluate by Spirometry

  3. Walking distance

    Time frame: 2 months

    Evaluate by six-minute walk test

  4. Quality of life

    Time frame: 2 months

    Evaluate by questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF

  5. Diaphragm mobility

    Time frame: 2 months

    Evaluate by ultrasound

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 9, 2015
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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