NCT06745310

Brief Summary

Individuals with high and normal body mass index will be included in this study.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 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

December 12, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 17, 2024

Last Update Submit

December 17, 2024

Conditions

Body Mass IndexBody Mass Index 25 or GreaterBody Mass Index, Normal

Outcome Measures

Primary Outcomes (2)

  • Upper extremity exercise capacity

    It will be assessed by 6 minute pegboard and ring test.

    1st day

  • Daily living activities

    It will be evaluated with the Glittre activities of daily living test.

    1st day

Secondary Outcomes (2)

  • Fatigue

    1st day

  • Pain

    1st day

Study Arms (2)

Individuals with high body mass index

Individuals with normal body mass index

Eligibility Criteria

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

Individuals with high and normal body mass index will be included in the study.

You may qualify if:

  • Body mass index ≥ 25 kg/m2
  • Volunteering for the study

You may not qualify if:

  • Having uncontrolled hypertension, diabetes mellitus
  • Having comorbidities that may affect physical functions
  • Failure to cooperate with tests to be performed
  • Liver disease, kidney disease, cancer, lung diseases and serious cardiomyopathies, neurological diseases
  • Pregnancy
  • Having a history of bariatric surgery
  • Presence of contraindications to exercise testing
  • Body mass index 18.5-24.9 kg/m2
  • Volunteering for the study
  • Body mass index \> 25 kg/m2 or ≤18.5 kg/m2
  • Having a known chronic or systemic disease
  • Failure to cooperate with tests to be performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirsehir Ahi Evran University

Kırşehir, 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

December 17, 2024

First Posted

December 20, 2024

Study Start

December 12, 2024

Primary Completion

May 1, 2025

Study Completion

December 1, 2025

Last Updated

December 20, 2024

Record last verified: 2024-12

Locations

TU(1)