CClinicalTrials.gg
RecruitingNCT06706492Updated Nov 26, 2024

Muscle Oxygenation, Functional Capacity and Frailty in Kidney Transplant Recipients with and Without Inspiratory Muscle Weakness

An observational study in Renal Transplantation, sponsored by Hacettepe University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Hacettepe University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
30
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Transplantation
03

In context

Muscle Weakness

601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.

This study's planned enrollment of 30 is below the median of 98 across 144 observational studies indexed under Muscle Weakness.

Browse Muscle Weakness 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
Sampling method
Non-probability sample

Study population

Kidney transplant recipients will be included.

Inclusion criteria

  • Patients with kidney transplantation
  • At least 6 months after the kidney transplant
  • Not having regular exercise habits
  • Voluntary participation in the study

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with inspiratory muscle weakness
  • Patients without inspiratory muscle weakness
06

What researchers measure

Primary outcomes

  1. Respiratory muscle strength

    Maximal inspiratory pressure (MIP) will be measured using a portable mouth pressure measuring device.

    Time frame: 1st day

  2. Respiratory muscle strength

    Maximal expiratory pressure (MEP) will be measured using a portable mouth pressure measuring device.

    Time frame: 1st day

  3. Functional capacity

    Will be evaluated with 6 minute walk test.

    Time frame: 1st day

  4. Peripheral muscle strength

    Knee extensor strength will be measured using a hand dynamometer.

    Time frame: 1st day

  5. Peripheral muscle strength

    Hand grip strength will be measured using grip dynamometer.

    Time frame: 1st day

Secondary outcomes

  1. Forced expiratory volume in one second

    Respiratory function will be evaluated using spirometry. Forced expiratory volume in one second will be recorded.

    Time frame: 1st day

  2. Forced vital capacity

    Respiratory function will be evaluated using spirometry. Forced vital capacity will be recorded.

    Time frame: 1st day

  3. 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.

    Time frame: 1st day

  4. Peak expiratory flow

    Respiratory function will be evaluated using spirometry. Peak expiratory flow will be recorded.

    Time frame: 1st day

  5. Forced mid-expiratory flow

    Respiratory function will be evaluated using spirometry. Forced mid-expiratory flow (FEF25-75) will be recorded.

    Time frame: 1st day

  6. Body composition

    It will be evaluated by bioelectrical impedance analysis method. Percentage of fat and lean body mass wiil be recorded.

    Time frame: 1st day

  7. 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.

    Time frame: 1st day

07

Study locations

1 of 1 sites recruiting
  • Hacettepe University
    Ankara, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06706492
Lead sponsor
Hacettepe University
Responsible party
Merve Firat (Assistant Professor, Kirsehir Ahi Evran Universitesi) — Principal investigator
First posted
Nov 26, 2024
Start date
Apr 6, 2024
Primary completion
Dec 2024 (estimated)
Completion
Aug 2025 (estimated)
Last update
Nov 26, 2024

Study contacts

Merve Firat
Contact
mervefirat@ahievran.edu.tr
+90 850 441 02 44
Naciye Vardar-Yagli
Contact
naciyevardar@yahoo.com
+90 312 305 15 76 ext. 123

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion