Functional Inspiratory Muscle Training in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

The Effects of Functional Inspiratory Muscle Training on Respiratory and Peripheral Muscle Functions in Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04958759
• Other study ID #: KA-20086
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 3, 2023

Study information

• Verified date: August 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effects of functional inspiratory muscle training by telerehabilitation on respiratory and peripheral functions, functional capacity, diaphragm thickness and mobility, posture, quality of life, cognitive function, fatigue, physical activity, endothelial function and aortic stiffness in patients with chronic kidney disease will be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 3, 2023
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with chronic kidney disease not receiving dialysis

• Access to the online program

• Volunteering to participate in the research

Exclusion Criteria:

• Having a musculoskeletal problem

• Having decompensated diabetes

• Having uncontrolled hypertension

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Functional Inspiratory Muscle Training
The inspiratory muscle training program will be consist of 4 weeks of foundation inspiratory muscle training and 6 weeks of functional inspiratory muscle training
• Inspiratory Muscle Training
The inspiratory muscle training program will be consist of 10 weeks of foundation inspiratory muscle training
• Breathing exercises
The program will be consist of 10 weeks of breathing exercises

Locations

Country	Name	City	State
Turkey	Hacettepe University, Faculty of Physical Therapy and Rehabilitation	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory muscle strength	Respiratory muscle strength will be evaluated using mouth pressure device	10 minutes
Primary	Respiratory muscle endurance	Respiratory muscle endurance will be evaluated using incremental load test	10 minutes
Primary	Pulmonary function	Pulmonary functions will be evaluated using spirometry	5 minutes
Primary	Peripheral muscle strength	Peripheral muscle strength will be evaluated using dynamometer	5 minutes
Primary	Endurance of trunk muscles	Endurance of trunk muscles will be evaluated using plank, side plank, flexor endurance and pelvic bridge test	10 minutes
Primary	Lower extremity muscle endurance	Lower extremity muscle endurance will be evaluated using sit-to-stand test	1 minutes
Primary	Functional capacity	Functional capacity will be evaluated using six-minute walk test	10 minutes
Primary	Diaphragm thickness and mobility	Diaphragm thickness and mobility will be evaluated using ultrasonography	20 minutes
Secondary	Balance	Balance will be evaluated using timed up and go test	5 minutes
Secondary	Static balance	Balance will be evaluated using one-legged standing test	5 minutes
Secondary	Posture	Posture will be evaluated using Corbin Postural Assessment scale. Lateral and posterior views will be assessed (0 = absent, 1 = mild, 2 = moderate, 3 = severe) and posture score will be determined as excellent (0-2), very good (3-4), good (5-7), fair (8-11) and poor (>12).	5 minutes
Secondary	Qol	Quality of life will be evaluated using Nottingham Health Profile	10 minutes
Secondary	Cognitive function	Cognitive function will be evaluated using Standardised Mini-Mental State Examination	5 minutes
Secondary	Fatigue	Fatigue will be evaluated using Multidimensional Assessment of Fatigue scale	5 minutes
Secondary	Physical activity	Physical activity level will be evaluated using International Physical Activity Questionnaire-Short Form	5 minutes
Secondary	Endothelial function	Endothelial function will be evaluated using echocardiography. After a resting baseline Brachial artery diameter will be recorded, the cuff used in blood pressure measurement will be inflated 25-50 mmHg above the systolic blood pressure value and maintaining that pressure for 5 min. The brachial artery diameter will be measured again after the cuff is deflated.	10 minutes
Secondary	Aortic stiffness	Aortic stiffness will be evaluated using transthoracic echocardiography. Aortic diameters can be measured by M-mode tracing of the level of 3-4 cms above the aortic valve during diastole and systole	10 minutes