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Functional Inspiratory Muscle Training in Chronic Kidney Disease

Primary Purpose

Chronic Kidney Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Functional Inspiratory Muscle Training
Inspiratory Muscle Training
Breathing exercises
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Respiratory muscle

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Functional Inspiratory Muscle Training Group

Inspiratory Muscle Training Group

Control Group

Arm Description

Functional inspiratory muscle training in patients with chronic kidney disease

Inspiratory muscle training in patients with chronic kidney disease

Breathing exercises in patients with chronic kidney disease

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2021
Last Updated
August 11, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04958759
Brief Title
Functional Inspiratory Muscle Training in Chronic Kidney Disease
Official Title
The Effects of Functional Inspiratory Muscle Training on Respiratory and Peripheral Muscle Functions in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
May 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Respiratory muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional Inspiratory Muscle Training Group
Arm Type
Experimental
Arm Description
Functional inspiratory muscle training in patients with chronic kidney disease
Arm Title
Inspiratory Muscle Training Group
Arm Type
Experimental
Arm Description
Inspiratory muscle training in patients with chronic kidney disease
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Breathing exercises in patients with chronic kidney disease
Intervention Type
Other
Intervention Name(s)
Functional Inspiratory Muscle Training
Intervention Description
The inspiratory muscle training program will be consist of 4 weeks of foundation inspiratory muscle training and 6 weeks of functional inspiratory muscle training
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
The inspiratory muscle training program will be consist of 10 weeks of foundation inspiratory muscle training
Intervention Type
Other
Intervention Name(s)
Breathing exercises
Intervention Description
The program will be consist of 10 weeks of breathing exercises
Primary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Respiratory muscle strength will be evaluated using mouth pressure device
Time Frame
10 minutes
Title
Respiratory muscle endurance
Description
Respiratory muscle endurance will be evaluated using incremental load test
Time Frame
10 minutes
Title
Pulmonary function
Description
Pulmonary functions will be evaluated using spirometry
Time Frame
5 minutes
Title
Peripheral muscle strength
Description
Peripheral muscle strength will be evaluated using dynamometer
Time Frame
5 minutes
Title
Endurance of trunk muscles
Description
Endurance of trunk muscles will be evaluated using plank, side plank, flexor endurance and pelvic bridge test
Time Frame
10 minutes
Title
Lower extremity muscle endurance
Description
Lower extremity muscle endurance will be evaluated using sit-to-stand test
Time Frame
1 minutes
Title
Functional capacity
Description
Functional capacity will be evaluated using six-minute walk test
Time Frame
10 minutes
Title
Diaphragm thickness and mobility
Description
Diaphragm thickness and mobility will be evaluated using ultrasonography
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Balance
Description
Balance will be evaluated using timed up and go test
Time Frame
5 minutes
Title
Static balance
Description
Balance will be evaluated using one-legged standing test
Time Frame
5 minutes
Title
Posture
Description
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).
Time Frame
5 minutes
Title
Qol
Description
Quality of life will be evaluated using Nottingham Health Profile
Time Frame
10 minutes
Title
Cognitive function
Description
Cognitive function will be evaluated using Standardised Mini-Mental State Examination
Time Frame
5 minutes
Title
Fatigue
Description
Fatigue will be evaluated using Multidimensional Assessment of Fatigue scale
Time Frame
5 minutes
Title
Physical activity
Description
Physical activity level will be evaluated using International Physical Activity Questionnaire-Short Form
Time Frame
5 minutes
Title
Endothelial function
Description
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.
Time Frame
10 minutes
Title
Aortic stiffness
Description
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
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merve Firat, MSc
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naciye Vardar-Yagli, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tolga Yildirim, MD
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deniz İnal-İnce, Professor
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Melda Saglam, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ebru Calik-Kutukcu, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmet Hakan Ates, MD
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Selin Ardali-Duzgun, MD
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
Facility Information:
Facility Name
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
City
Ankara
Country
Turkey

12. IPD Sharing Statement

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Functional Inspiratory Muscle Training in Chronic Kidney Disease

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