NCT05777252

Brief Summary

The aim of this study is to investigate the effects of 16-week CT on spine structure, trunk muscle endurance, and balance in healthy women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

March 8, 2023

Last Update Submit

August 3, 2023

Conditions

Keywords

Health statusExerciseSpinePhysical fitnessWomen

Outcome Measures

Primary Outcomes (3)

  • Posture (°)

    Posture will be assessed with the Spinal Mouse® (Switzerland) device. The device has a measurement option different planes, provides the opportunity to evaluate both the posture and mobility of the spine, and gives valid, and reliable results. During the assessment, the processus spinosus of the spine from C7 to S3 will be marked and the mouse will be slide along the spine from top to bottom from the skin surface at a constant speed and pressure. Assessment were performed in an upright position for spinal posture.

    Sixteen week

  • Mobility (°)

    Mobility will be assessed with the Spinal Mouse® (Switzerland) device. The device has a measurement option different planes, provides the opportunity to evaluate both the posture and mobility of the spine, and gives valid, and reliable results. During the assessment, the processus spinosus of the spine from C7 to S3 will be marked and the mouse will be slide along the spine from top to bottom from the skin surface at a constant speed and pressure. The assessment were performed in maximum forward flexion position for spine mobility.

    Sixteen week

  • Postural Competency (°)

    Mobility will be assessed with the Spinal Mouse® (Switzerland) device. The device has a measurement option different planes, provides the opportunity to evaluate both the posture and mobility of the spine, and gives valid, and reliable results. During the assessment, the processus spinosus of the spine from C7 to S3 will be marked and the mouse will be slide along the spine from top to bottom from the skin surface at a constant speed and pressure. The assessment were performed in raising stretched-out arms to shoulder height with weights, designed according to the body weight, in each hand for postural competency.

    Sixteen week

Secondary Outcomes (2)

  • Trunk Muscle Endurance (sec)

    Sixteen week

  • Balance

    sixteen week

Study Arms (1)

Training Group

EXPERIMENTAL

Circuit training will be applied to the participants for a total of 16 weeks, with an average of 40 minutes a day, 3 days a week, taking into account the recommendations of the American College of Sports Medicine (ACSM).

Other: Circuit Training

Interventions

Warm-up and cool-down protocols will be applied before and after each CT, and each exercise will be performed as 15 repetitions and an average of 40 seconds of rest will be given between exercises. Also, the intensity of CT will be determined according to the Borg scale (between 11 and 14). CT will include 'mini squat', 'step up', 'sit ups', 'reverse sit ups', 'leg press', 'leg curl', 'leg extension', 'crunches', 'lunge', 'prone bridge', and 'side bridge' exercises.

Training Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBeing women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • volunteering to participate in study
  • not have any systemic, neurological, or rheumatological disease

You may not qualify if:

  • history of malignancy
  • participating in another exercise training during the study
  • using any medication that could affect the outcome of the study
  • being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

Location

İzmir Katip Celebi University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Circuit-Based Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Derya Ozer Kaya

    Izmir Katip Celebi University

    PRINCIPAL INVESTIGATOR
  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Prospective clinic study with a single group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 21, 2023

Study Start

March 15, 2023

Primary Completion

July 15, 2023

Study Completion

July 15, 2023

Last Updated

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

The investigators do not want to share individual participant data

Locations