Functional Inspiratory Muscle Training in Chronic Kidney Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: Functional Inspiratory Muscle Training; Other: Inspiratory Muscle Training; Other: Breathing exercises

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional Inspiratory Muscle Training Group; Functional inspiratory muscle training in patients with chronic kidney disease	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; Other: Inspiratory Muscle Training; The inspiratory muscle training program will be consist of 10 weeks of foundation inspiratory muscle training
Experimental: Inspiratory Muscle Training Group; Inspiratory muscle training in patients with chronic kidney disease	Other: Inspiratory Muscle Training; The inspiratory muscle training program will be consist of 10 weeks of foundation inspiratory muscle training
Experimental: Control Group; Breathing exercises in patients with chronic kidney disease	Other: Breathing exercises; The program will be consist of 10 weeks of breathing exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscle strength	Respiratory muscle strength will be evaluated using mouth pressure device	10 minutes
Respiratory muscle endurance	Respiratory muscle endurance will be evaluated using incremental load test	10 minutes
Pulmonary function	Pulmonary functions will be evaluated using spirometry	5 minutes
Peripheral muscle strength	Peripheral muscle strength will be evaluated using dynamometer	5 minutes
Endurance of trunk muscles	Endurance of trunk muscles will be evaluated using plank, side plank, flexor endurance and pelvic bridge test	10 minutes
Lower extremity muscle endurance	Lower extremity muscle endurance will be evaluated using sit-to-stand test	1 minutes
Functional capacity	Functional capacity will be evaluated using six-minute walk test	10 minutes
Diaphragm thickness and mobility	Diaphragm thickness and mobility will be evaluated using ultrasonography	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	Balance will be evaluated using timed up and go test	5 minutes
Static balance	Balance will be evaluated using one-legged standing test	5 minutes
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
Qol	Quality of life will be evaluated using Nottingham Health Profile	10 minutes
Cognitive function	Cognitive function will be evaluated using Standardised Mini-Mental State Examination	5 minutes
Fatigue	Fatigue will be evaluated using Multidimensional Assessment of Fatigue scale	5 minutes
Physical activity	Physical activity level will be evaluated using International Physical Activity Questionnaire-Short Form	5 minutes
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
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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: Tolga Yildirim, MD, Hacettepe University; Study Chair: Ahmet Hakan Ates, MD, Hacettepe University; Study Chair: Selin Ardali-Duzgun, MD, Hacettepe University; Study Chair: Melda Saglam, PhD, Hacettepe University; Principal Investigator: Merve Firat, MSc, Hacettepe University; Study Director: Naciye Vardar-Yagli, PhD, Hacettepe University; Study Chair: Deniz İnal-İnce, Professor, Hacettepe University; Study Chair: Ebru Calik-Kutukcu, PhD, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Respiratory muscle
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: KA-20086

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No