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

Recruiting

• Conditions: Renal Transplantation

• Registration Number: NCT06706492
• Lead Sponsor: Hacettepe University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-06
• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Primary Completion: 2024-12
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory muscle strength	1st day	Maximal expiratory pressure (MEP) will be measured using a portable mouth pressure measuring device.
Functional capacity	1st day	Will be evaluated with 6 minute walk test.
Peripheral muscle strength	1st day	Hand grip strength will be measured using grip dynamometer.

Secondary Outcome Measures

Name	Time	Method
Forced expiratory volume in one second	1st day	Respiratory function will be evaluated using spirometry. Forced expiratory volume in one second will be recorded.
Forced vital capacity	1st day	Respiratory function will be evaluated using spirometry. Forced vital capacity will be recorded.
Forced expiratory volume in one second/forced vital capacity	1st day	Respiratory function will be evaluated using spirometry. Forced expiratory volume in one second/forced vital capacity will be recorded.
Peak expiratory flow	1st day	Respiratory function will be evaluated using spirometry. Peak expiratory flow will be recorded.
Forced mid-expiratory flow	1st day	Respiratory function will be evaluated using spirometry. Forced mid-expiratory flow (FEF25-75) will be recorded.
Body composition	1st day	It will be evaluated by bioelectrical impedance analysis method. Percentage of fat and lean body mass wiil be recorded.
Fragility	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.

Trial Locations

Locations (1)

Hacettepe University; 🇹🇷 Ankara, Turkey