NCT05564364

Brief Summary

The design of our study is a prospective. It is planned to be completed in twenty-four weeks with 34 participants. The main purpose of this study is to examine and compare the effects of two different bike exercises on knee joint and lower extremity muscles by ultrasonographic method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 22, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

September 22, 2022

Last Update Submit

February 6, 2024

Conditions

Keywords

Knee JointExerciseUltrasoundBicycle

Outcome Measures

Primary Outcomes (2)

  • Baseline knee joint cartilage thickness and muscles thicknesses

    Ultrasonographic measurements will be made using linear probes (5-13 megahertz Logiq P5; GE Medical Systems) .Joint cartillage thickness and lower extremity muscles will measured by ultrasound at baseline.

    Just before first exercises session

  • Knee cartilage thickness and muscles thicknesses after 6 weeks training program

    Ultrasonographic measurements will be made using linear probes (5-13 megahertz Logiq P5; GE Medical Systems) .Joint cartillage and lower extremity muscles will measured by ultrasound after 6 weeks training program. Joint cartillage thickness and lower extremity muscles will measured by ultrasound after 6 weeks.

    After 6 weeks training program

Study Arms (2)

Healthy Controls 1

EXPERIMENTAL

Healthy individuals participating in the study will be divided into two groups.

Device: Recumbent Bike

Healthy Controls 2

EXPERIMENTAL

Healthy individuals participating in the study will be divided into two groups.

Device: Upright Bike

Interventions

The first group will exercise with a recumbent bike for 20 minutes, 3 sessions/week for 6 weeks.

Healthy Controls 1

The first group will exercise with a upright bike for 20 minutes, 3 sessions/week for 6 weeks.

Healthy Controls 2

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-35
  • Not exercising regularly
  • BMI between 18.9-24.9 kg/m2
  • Volunteering to participate in the study
  • Absence of chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program.
  • Those who do not have a history of pregnancy, malignant hematological and oncological diseases
  • Not smoking
  • No musculoskeletal problems of the lower extremity in the last 6 months
  • No previous history of lower extremity surgery in the last 1 year

You may not qualify if:

  • Being outside the age range of 18-35
  • Exercising regularly
  • Being outside of the BMI 18.9-24.9 kg/m2 range
  • Having chronic rheumatic, cardiovascular, neurological, pulmonary or other system diseases that may prevent participation in the exercise program
  • Those with a history of pregnancy, malignant hematological and oncological diseases
  • Individuals who smoke
  • Any musculoskeletal problem of the lower extremity in the last 6 months
  • Having a history of lower extremity surgery in the last 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Department of Physical Medicine and Rehabilitation

Mersin, 33110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Orhan Güvener, MD

    Mersin University Medical School

    PRINCIPAL INVESTIGATOR
  • Figen Dağ, PhD

    Mersin University Medical School

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant of Professor

Study Record Dates

First Submitted

September 22, 2022

First Posted

October 3, 2022

Study Start

November 15, 2022

Primary Completion

September 15, 2023

Study Completion

November 15, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations