Renal TransplantationNCT06706492
Muscle Oxygenation, Functional Capacity and Frailty in Kidney Transplant Recipients with and Without Inspiratory Muscle Weakness
An observational study of Renal Transplantation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare respiratory function, muscle oxygenation, functional capacity, peripheral muscle strength, body composition, and frailty in kidney transplant recipients with and without inspiratory muscle weakness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplantation
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2024to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Kidney transplant recipients will be included.
Who may be able to join
- Patients with kidney transplantation
- At least 6 months after the kidney transplant
- Not having regular exercise habits
- Voluntary participation in the study
Who cannot join
- Having a musculoskeletal problem that may interfere with the tests
- Having neurological impairment
- Having chronic lung disease
- Having had any cardiovascular event in the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara
Naciye Vardar-Yagli, +90 312 305 15 76 ext. 123, naciyevardar@yahoo.com
About this study
Official title: Comparison of Muscle Oxygenation, Functional Capacity, and Frailty in Kidney Transplant Recipients with and Without Inspiratory Muscle Weakness
The aim of this study was to compare respiratory function, muscle oxygenation, functional capacity, peripheral muscle strength, body composition, and frailty in kidney transplant recipients with and without inspiratory muscle weakness.
- Conditions
- Renal Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with inspiratory muscle weakness | Not described | |
| Patients without inspiratory muscle weakness | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle strength
Maximal inspiratory pressure (MIP) will be measured using a portable mouth pressure measuring device.
Measured: 1st day
Respiratory muscle strength
Maximal expiratory pressure (MEP) will be measured using a portable mouth pressure measuring device.
Measured: 1st day
Functional capacity
Will be evaluated with 6 minute walk test.
Measured: 1st day
Peripheral muscle strength
Knee extensor strength will be measured using a hand dynamometer.
Measured: 1st day
Peripheral muscle strength
Hand grip strength will be measured using grip dynamometer.
Measured: 1st day
Secondary outcomes (7)
Forced expiratory volume in one second
Respiratory function will be evaluated using spirometry. Forced expiratory volume in one second will be recorded.
Measured: 1st day
Forced vital capacity
Respiratory function will be evaluated using spirometry. Forced vital capacity will be recorded.
Measured: 1st day
Forced expiratory volume in one second/forced vital capacity
Respiratory function will be evaluated using spirometry. Forced expiratory volume in one second/forced vital capacity will be recorded.
Measured: 1st day
Peak expiratory flow
Respiratory function will be evaluated using spirometry. Peak expiratory flow will be recorded.
Measured: 1st day
Forced mid-expiratory flow
Respiratory function will be evaluated using spirometry. Forced mid-expiratory flow (FEF25-75) will be recorded.
Measured: 1st day
Body composition
It will be evaluated by bioelectrical impedance analysis method. Percentage of fat and lean body mass wiil be recorded.
Measured: 1st day
Fragility
It will be assessed according to the criteria defined by Fried. The existence of 5 parameters is questioned here. These parameters are as follows: weight loss, weakness, fatigue, slowness, low physical activity. Those with 3 or more of the 5 identified components are classified as fragile.
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start6 Apr 2024
- Primary completionDec 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Firat, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706492
- Sponsor's protocol ID
- SBA 23/286
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Muscle Oxygenation, Functional Capacity, and Frailty in Kidney Transplant Recipients with and Without Inspiratory Muscle Weakness
- ClinicalTrials.gov ID
- NCT06706492
- Acronym / sponsor ID
- SBA 23/286
- Conditions
- Renal Transplantation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 6 Apr 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 26 Nov 2024 (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.
The aim of this study was to compare respiratory function, muscle oxygenation, functional capacity, peripheral muscle strength, body composition, and frailty in kidney transplant recipients with and without inspiratory muscle weakness.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with inspiratory muscle weakness | – | – |
| Patients without inspiratory muscle weakness | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients will be included.
Key inclusion criteria (4 listed)
- Patients with kidney transplantation
- At least 6 months after the kidney transplant
- Not having regular exercise habits
- Voluntary participation in the study
Key exclusion criteria (4 listed)
- Having a musculoskeletal problem that may interfere with the tests
- Having neurological impairment
- Having chronic lung disease
- Having had any cardiovascular event in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory muscle strength
Time frame: 1st day
Maximal inspiratory pressure (MIP) will be measured using a portable mouth pressure measuring device.
Respiratory muscle strength
Time frame: 1st day
Maximal expiratory pressure (MEP) will be measured using a portable mouth pressure measuring device.
Functional capacity
Time frame: 1st day
Will be evaluated with 6 minute walk test.
Peripheral muscle strength
Time frame: 1st day
Knee extensor strength will be measured using a hand dynamometer.
Peripheral muscle strength
Time frame: 1st day
Hand grip strength will be measured using grip dynamometer.
7 secondary outcomes
Forced expiratory volume in one second
Time frame: 1st day
Forced vital capacity
Time frame: 1st day
Forced expiratory volume in one second/forced vital capacity
Time frame: 1st day
Peak expiratory flow
Time frame: 1st day
Forced mid-expiratory flow
Time frame: 1st day
Body composition
Time frame: 1st day
Fragility
Time frame: 1st day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplantation, 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Firat (+90 850 441 02 44, mervefirat@ahievran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle strength (time frame: 1st day). The study lists 5 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 26 Nov 2024.