NCT04972305

Brief Summary

The aim of this study is to determine the effects of personal ergonomic adaptations of the bicycle on the bicycle performance parameters, together with the exercise program training created to prevent biomechanical problems that cause injuries in recreational cyclist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

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

July 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

9 months

First QC Date

July 15, 2021

Last Update Submit

August 3, 2022

Conditions

Sports Physical Therapy

Keywords

recreational cyclistexercisephysical fitnesssports performance

Outcome Measures

Primary Outcomes (10)

  • Body Composition

    Body fat percentage will be determined by skinfold measurement

    Change from Baseline at 12th weeks and 6th month

  • Muscle strength

    It will be measured with "1 max rep" (1RM).

    Change from Baseline at 12th weeks and 6th month

  • Flexibility

    It will be evaluated with sit-reach test and modified ober test.

    Change from Baseline at 12th weeks and 6th month

  • Aerobic Capacity

    It will be evaluated by shuttle run.

    Change from Baseline at 12th weeks and 6th month

  • Functional threshold power test (FTP)

    It is obtained by calculating the force applied while pedaling for 20 minutes.

    Change from Baseline at 12th weeks and 6th month

  • Lactate threshold heart rate

    Average heart rate taken while pedaling for 20 minutes.

    Change from Baseline at 12th weeks and 6th month

  • 10-Mile Trial Test

    The time it takes to complete 10 miles in the fastest possible time is counted.

    Change from Baseline at 12th weeks and 6th month

  • Critical Power test

    It is the estimation of the maximum effort that can be sustained for 3 minutes.

    Change from Baseline at 12th weeks and 6th month

  • Muscle myotonometric properties

    It will be measured with myoton pro.

    Change from Baseline at 12th weeks and 6th month

  • Balance

    It will be measured with Y balance test.

    Change from Baseline at 12th weeks and 6th month

Secondary Outcomes (2)

  • Perceived pain

    Change from Baseline at 12th weeks and 6th month

  • İnjury

    Change from Baseline at 12th weeks and 6th month

Study Arms (3)

Exercise group

EXPERIMENTAL

12 weeks exercise programme, 3 days a week Bicycle ergonomics will be applied.

Other: Exercise and ergonomics

Ergonomics group

EXPERIMENTAL

Bicycle ergonomics will be applied.

Other: Ergonomics

Control group

NO INTERVENTION

No Intervention

Interventions

Exercise and ergonomicsOTHER

12 week exercise and fit bike

Exercise group
ErgonomicsOTHER

Fit bike

Ergonomics group

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recreational cycling for at least 1 year
  • body mass index between 18.5-25 kg / m²
  • Obtaining a written health report stating "there is no harm in using a bicycle"

You may not qualify if:

  • History of fracture, trauma or surgery in the last 6 months
  • have any systemic or neurological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yusuf Şinasi Kirmaci

Gaziantep, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseErgonomics

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEngineeringTechnology, Industry, and Agriculture

Study Officials

  • GÜNSELİ USGU

    Hasan Kalyoncu University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 15, 2021

First Posted

July 22, 2021

Study Start

August 1, 2021

Primary Completion

April 30, 2022

Study Completion

May 30, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)