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NCT Number: NCT06706492

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Primary outcomes

  1. Respiratory muscle strength

    Time frame: 1st day

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

  2. Respiratory muscle strength

    Time frame: 1st day

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

  3. Functional capacity

    Time frame: 1st day

    Will be evaluated with 6 minute walk test.

  4. Peripheral muscle strength

    Time frame: 1st day

    Knee extensor strength will be measured using a hand dynamometer.

  5. Peripheral muscle strength

    Time frame: 1st day

    Hand grip strength will be measured using grip dynamometer.

Secondary outcomes

  1. Forced expiratory volume in one second

    Time frame: 1st day

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

  2. Forced vital capacity

    Time frame: 1st day

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

  3. Forced expiratory volume in one second/forced vital capacity

    Time frame: 1st day

    Respiratory function will be evaluated using spirometry. Forced expiratory volume in one second/forced vital capacity will be recorded.

  4. Peak expiratory flow

    Time frame: 1st day

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

  5. Forced mid-expiratory flow

    Time frame: 1st day

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

  6. Body composition

    Time frame: 1st day

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

  7. Fragility

    Time frame: 1st day

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Merve Firat

CONTACT

[email protected]

+90 850 441 02 44

Naciye Vardar-Yagli

CONTACT

[email protected]

+90 312 305 15 76 ext. 123

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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