NCT06706154

Brief Summary

This study aimed to determine the determinants of 6 minute walk test distance in patients with kidney transplant recipients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

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

August 17, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 4, 2024

Last Update Submit

November 22, 2024

Conditions

Renal Transplantation

Outcome Measures

Primary Outcomes (4)

  • Exercise capacity

    Will be evaluated with 6 minute walk test. After the test, total walking distance will be recorded.

    1st day

  • Respiratory function

    FEV1, FVC, FEV1/FVC, PEF, FEF25-75 will be measured by lung function test.

    1st day

  • Respiratory muscle strength

    Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using a mouth pressure device.

    1st day

  • Musle function

    Knee extensor and hand grip strength will be evaluated with a dynamometer.

    1st day

Secondary Outcomes (1)

  • Physical activity

    1st day

Study Arms (1)

Kidney transplant recipients

Eligibility Criteria

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

Patients with kidney transplantation will be included.

You may qualify if:

  • Patients with kidney transplantation
  • At least 6 months after the kidney transplant
  • Being aged 18-65
  • 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

Merve Firat

CONTACT

+90 850 441 02 44mervefirat@ahievran.edu.tr

Study Design

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

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 26, 2024

Study Start

August 17, 2024

Primary Completion

January 1, 2025

Study Completion

May 1, 2025

Last Updated

November 26, 2024

Record last verified: 2024-11

Locations

TU(1)