NCT06706492

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 19, 2024

Last Update Submit

November 22, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Respiratory muscle strength

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

    1st day

  • Respiratory muscle strength

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

    1st day

  • Functional capacity

    Will be evaluated with 6 minute walk test.

    1st day

  • Peripheral muscle strength

    Knee extensor strength will be measured using a hand dynamometer.

    1st day

  • Peripheral muscle strength

    Hand grip strength will be measured using grip dynamometer.

    1st day

Secondary Outcomes (7)

  • Forced expiratory volume in one second

    1st day

  • Forced vital capacity

    1st day

  • Forced expiratory volume in one second/forced vital capacity

    1st day

  • Peak expiratory flow

    1st day

  • Forced mid-expiratory flow

    1st day

  • +2 more secondary outcomes

Study Arms (2)

Patients with inspiratory muscle weakness

Patients without inspiratory muscle weakness

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney transplant recipients will be included.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 19, 2024

First Posted

November 26, 2024

Study Start

April 6, 2024

Primary Completion

December 1, 2024

Study Completion

August 1, 2025

Last Updated

November 26, 2024

Record last verified: 2024-11

Locations