NCT05097196

Brief Summary

The aim of this study is to determine the effects of commercially produced new generation smart step board and step-aerobic exercises for 6 weeks on the functional capacity and physical performance of young sedentary individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 28, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

January 30, 2024

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

September 26, 2021

Last Update Submit

January 29, 2024

Conditions

Keywords

home-based exercisestep-aerobic exercisewearable technology

Outcome Measures

Primary Outcomes (2)

  • Functional capacity

    Six minute walk test (6MWT) distance of the participants will be evaluated using the G-Walk sensor system

    10 weeks

  • Resting heart rate

    Resting heart rate measurements are beats per minute taken in the morning

    10 weeks

Secondary Outcomes (4)

  • Flamingo Balance Test

    10 weeks

  • Quadriceps Strength

    10 weeks

  • Counter movement jump

    10 weeks

  • Exercise motivation

    10 weeks

Study Arms (1)

Step Aerobic Group

EXPERIMENTAL

Step aerobic exercise

Other: Moderate-intensity aerobic activities

Interventions

The exercise intensity of the individual is planned at 50-60% heart rate reserve using the Karvonen method.

Step Aerobic Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Not participating in an exercise program that is followed regularly for at least 6 months
  • Able to use a wearable device and willing to regularly step aerobic exercise
  • In possession of a smart phone, tablet or computer
  • BMI 25 to 40 kg/m2

You may not qualify if:

  • Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer, and cardiovascular, orthopedic, neurological psychological other diseases
  • Not continuing the exercise program for more than three
  • Loss of balance due to loss of consciousness or dizziness in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Science University

Afyonkarahisar, Turkey (Türkiye)

Location

Study Officials

  • Yunus Emre Kundakci, PhD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PhD

Study Record Dates

First Submitted

September 26, 2021

First Posted

October 28, 2021

Study Start

December 30, 2021

Primary Completion

May 10, 2022

Study Completion

September 20, 2022

Last Updated

January 30, 2024

Record last verified: 2023-05

Locations