Chronic Kidney DiseasesNCT04958759
Functional Inspiratory Muscle Training in Chronic Kidney Disease
A study testing Functional Inspiratory Muscle Training, Inspiratory Muscle Training and Breathing exercises in people with Chronic Kidney Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Functional Inspiratory Muscle Training, Inspiratory Muscle Training and Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 3 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic kidney disease not receiving dialysis
- Access to the online program
- Volunteering to participate in the research
Who cannot join
- Having a musculoskeletal problem
- Having decompensated diabetes
- Having uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara
About this study
Official title: 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Functional Inspiratory Muscle Training, Inspiratory Muscle Training, Breathing exercises
- Keywords
- Respiratory muscle
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Inspiratory Muscle TrainingOther
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 TrainingOther
The inspiratory muscle training program will be consist of 10 weeks of foundation inspiratory muscle training
Breathing exercisesOther
The program will be consist of 10 weeks of breathing exercises
| Study group | Role | What they receive |
|---|---|---|
| Functional Inspiratory Muscle Training Group | Experimental | Functional inspiratory muscle training in patients with chronic kidney disease Receives: Other: Functional Inspiratory Muscle Training; Other: Inspiratory Muscle Training |
| Inspiratory Muscle Training Group | Experimental | Inspiratory muscle training in patients with chronic kidney disease Receives: Other: Inspiratory Muscle Training |
| Control Group | Experimental | Breathing exercises in patients with chronic kidney disease Receives: Other: Breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
Respiratory muscle strength will be evaluated using mouth pressure device
Measured: 10 minutes
Respiratory muscle endurance
Respiratory muscle endurance will be evaluated using incremental load test
Measured: 10 minutes
Pulmonary function
Pulmonary functions will be evaluated using spirometry
Measured: 5 minutes
Peripheral muscle strength
Peripheral muscle strength will be evaluated using dynamometer
Measured: 5 minutes
Endurance of trunk muscles
Endurance of trunk muscles will be evaluated using plank, side plank, flexor endurance and pelvic bridge test
Measured: 10 minutes
Lower extremity muscle endurance
Lower extremity muscle endurance will be evaluated using sit-to-stand test
Measured: 1 minutes
Functional capacity
Functional capacity will be evaluated using six-minute walk test
Measured: 10 minutes
Diaphragm thickness and mobility
Diaphragm thickness and mobility will be evaluated using ultrasonography
Measured: 20 minutes
Secondary outcomes (9)
Balance
Balance will be evaluated using timed up and go test
Measured: 5 minutes
Static balance
Balance will be evaluated using one-legged standing test
Measured: 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).
Measured: 5 minutes
Qol
Quality of life will be evaluated using Nottingham Health Profile
Measured: 10 minutes
Cognitive function
Cognitive function will be evaluated using Standardised Mini-Mental State Examination
Measured: 5 minutes
Fatigue
Fatigue will be evaluated using Multidimensional Assessment of Fatigue scale
Measured: 5 minutes
Physical activity
Physical activity level will be evaluated using International Physical Activity Questionnaire-Short Form
Measured: 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.
Measured: 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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Mar 2021
- Primary completion9 Sep 2022
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Firat, Hacettepe University
- Investigators
- Merve Firat, MSc, Principal investigator, Hacettepe UniversityNaciye Vardar-Yagli, PhD, Study director, Hacettepe UniversityTolga Yildirim, MD, Study director, Hacettepe UniversityDeniz İnal-İnce, Professor, Study chair, Hacettepe UniversityMelda Saglam, PhD, Study chair, Hacettepe UniversityEbru Calik-Kutukcu, PhD, Study chair, Hacettepe UniversityAhmet Hakan Ates, MD, Study chair, Hacettepe UniversitySelin Ardali-Duzgun, MD, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958759
- Sponsor's protocol ID
- KA-20086
- Status last verified
- Aug 2023
- First submitted
- 12 May 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Functional Inspiratory Muscle Training on Respiratory and Peripheral Muscle Functions in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04958759
- Acronym / sponsor ID
- KA-20086
- Conditions
- Chronic Kidney Diseases
- Keywords
- Respiratory muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Functional Inspiratory Muscle Training Group | Experimental | Other: Functional Inspiratory Muscle Training, Other: Inspiratory Muscle TrainingFunctional inspiratory muscle training in patients with chronic kidney disease |
| Inspiratory Muscle Training Group | Experimental | Other: Inspiratory Muscle TrainingInspiratory muscle training in patients with chronic kidney disease |
| Control Group | Experimental | Other: Breathing exercisesBreathing exercises in patients with chronic kidney disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with chronic kidney disease not receiving dialysis
- Access to the online program
- Volunteering to participate in the research
Key exclusion criteria (3 listed)
- Having a musculoskeletal problem
- Having decompensated diabetes
- Having uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Inspiratory Muscle TrainingThe inspiratory muscle training program will be consist of 4 weeks of foundation inspiratory muscle training and 6 weeks of functional inspiratory muscle training | Other | Functional Inspiratory Muscle Training Group |
| Inspiratory Muscle TrainingThe inspiratory muscle training program will be consist of 10 weeks of foundation inspiratory muscle training | Other | Functional Inspiratory Muscle Training Group, Inspiratory Muscle Training Group |
| Breathing exercisesThe program will be consist of 10 weeks of breathing exercises | Other | Control Group |
Primary outcome
Respiratory muscle strength
Time frame: 10 minutes
Respiratory muscle strength will be evaluated using mouth pressure device
Respiratory muscle endurance
Time frame: 10 minutes
Respiratory muscle endurance will be evaluated using incremental load test
Pulmonary function
Time frame: 5 minutes
Pulmonary functions will be evaluated using spirometry
Peripheral muscle strength
Time frame: 5 minutes
Peripheral muscle strength will be evaluated using dynamometer
Endurance of trunk muscles
Time frame: 10 minutes
Endurance of trunk muscles will be evaluated using plank, side plank, flexor endurance and pelvic bridge test
Lower extremity muscle endurance
Time frame: 1 minutes
Lower extremity muscle endurance will be evaluated using sit-to-stand test
Functional capacity
Time frame: 10 minutes
Functional capacity will be evaluated using six-minute walk test
Diaphragm thickness and mobility
Time frame: 20 minutes
Diaphragm thickness and mobility will be evaluated using ultrasonography
9 secondary outcomes
Balance
Time frame: 5 minutes
Static balance
Time frame: 5 minutes
Posture
Time frame: 5 minutes
Qol
Time frame: 10 minutes
Cognitive function
Time frame: 5 minutes
Fatigue
Time frame: 5 minutes
Physical activity
Time frame: 5 minutes
Endothelial function
Time frame: 10 minutes
Aortic stiffness
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Firat, MSc principal investigator
Hacettepe University
Naciye Vardar-Yagli, PhD study director
Hacettepe University
Tolga Yildirim, MD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Inspiratory Muscle Training, Inspiratory Muscle Training and Breathing exercises in people with Chronic Kidney Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle strength (time frame: 10 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.