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CompletedNCT04958759Updated Aug 14, 2023

Functional Inspiratory Muscle Training in Chronic Kidney Disease

An interventional study of Functional Inspiratory Muscle Training and Inspiratory Muscle Training in Chronic Kidney Diseases, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Diseases

Keywords

  • Respiratory muscle
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 38 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with chronic kidney disease not receiving dialysis
  • Access to the online program
  • Volunteering to participate in the research

Exclusion criteria

Exclusion Criteria:

  • Having a musculoskeletal problem
  • Having decompensated diabetes
  • Having uncontrolled hypertension
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Functional Inspiratory Muscle Training Group

    Functional inspiratory muscle training in patients with chronic kidney disease

    Other: Functional Inspiratory Muscle Training · Other: Inspiratory Muscle Training

  • Experimental
    Inspiratory Muscle Training Group

    Inspiratory muscle training in patients with chronic kidney disease

    Other: Inspiratory Muscle Training

  • Experimental
    Control Group

    Breathing exercises in patients with chronic kidney disease

    Other: Breathing exercises

Interventions

  • OtherFunctional 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

  • OtherInspiratory Muscle Training

    The inspiratory muscle training program will be consist of 10 weeks of foundation inspiratory muscle training

  • OtherBreathing exercises

    The program will be consist of 10 weeks of breathing exercises

06

What researchers measure

Primary outcomes

  1. Respiratory muscle strength

    Respiratory muscle strength will be evaluated using mouth pressure device

    Time frame: 10 minutes

  2. Respiratory muscle endurance

    Respiratory muscle endurance will be evaluated using incremental load test

    Time frame: 10 minutes

  3. Pulmonary function

    Pulmonary functions will be evaluated using spirometry

    Time frame: 5 minutes

  4. Peripheral muscle strength

    Peripheral muscle strength will be evaluated using dynamometer

    Time frame: 5 minutes

  5. Endurance of trunk muscles

    Endurance of trunk muscles will be evaluated using plank, side plank, flexor endurance and pelvic bridge test

    Time frame: 10 minutes

  6. Lower extremity muscle endurance

    Lower extremity muscle endurance will be evaluated using sit-to-stand test

    Time frame: 1 minutes

  7. Functional capacity

    Functional capacity will be evaluated using six-minute walk test

    Time frame: 10 minutes

  8. Diaphragm thickness and mobility

    Diaphragm thickness and mobility will be evaluated using ultrasonography

    Time frame: 20 minutes

Secondary outcomes

  1. Balance

    Balance will be evaluated using timed up and go test

    Time frame: 5 minutes

  2. Static balance

    Balance will be evaluated using one-legged standing test

    Time frame: 5 minutes

  3. 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).

    Time frame: 5 minutes

  4. Qol

    Quality of life will be evaluated using Nottingham Health Profile

    Time frame: 10 minutes

  5. Cognitive function

    Cognitive function will be evaluated using Standardised Mini-Mental State Examination

    Time frame: 5 minutes

  6. Fatigue

    Fatigue will be evaluated using Multidimensional Assessment of Fatigue scale

    Time frame: 5 minutes

  7. Physical activity

    Physical activity level will be evaluated using International Physical Activity Questionnaire-Short Form

    Time frame: 5 minutes

  8. 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.

    Time frame: 10 minutes

  9. 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

    Time frame: 10 minutes

07

Study locations

1 site
  • Hacettepe University, Faculty of Physical Therapy and Rehabilitation
    Ankara, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04958759
Lead sponsor
Hacettepe University
Responsible party
Merve Firat (Research assistant, Hacettepe University) — Principal investigator
First posted
Jul 12, 2021
Start date
Mar 1, 2021
Primary completion
Sep 9, 2022
Completion
May 3, 2023
Last update
Aug 14, 2023

Study contacts

Merve Firat, MSc
principal investigator · Hacettepe University
Naciye Vardar-Yagli, PhD
study director · Hacettepe University
Tolga Yildirim, MD
study director · Hacettepe University
Deniz İnal-İnce, Professor
study chair · Hacettepe University
Melda Saglam, PhD
study chair · Hacettepe University
Ebru Calik-Kutukcu, PhD
study chair · Hacettepe University
Ahmet Hakan Ates, MD
study chair · Hacettepe University
Selin Ardali-Duzgun, MD
study chair · Hacettepe University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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