NCT06707792

Brief Summary

The aim of our study was to investigate the validity and reliability of the 6 minute stepper test in 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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 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

June 9, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

November 25, 2024

Last Update Submit

November 27, 2024

Conditions

Renal Transplanted Recipients

Outcome Measures

Primary Outcomes (4)

  • Exercise capacity

    Exercise capacity will be assessed with a 6 minute stepper test.

    Day 1

  • Exercise capacity

    Exercise capacity will be assessed with a 6 minute walk test.

    Day 1

  • Peripheral muscle strength

    Knee extensor strength will be measured using a portable portable handheld dynamometer.

    Day 1

  • Lower extremity endurance

    It will be evaluated with a one-minute sit to stand test.

    Day 1

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

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

Merve Firat

CONTACT

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

Naciye Vardar-Yagli

CONTACT

+903123051576naciyevardar@yahoo.com

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 25, 2024

First Posted

November 27, 2024

Study Start

June 9, 2024

Primary Completion

January 1, 2025

Study Completion

December 1, 2025

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

TU(1)