Aerobic ExerciseNCT05097196
Effects of Home Based Step Aerobic Exercises
A study testing Moderate-intensity aerobic activities in people with Aerobic Exercise, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aerobic Exercise
- What is being tested?
- Moderate-intensity aerobic activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2021to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Science University
Afyonkarahisar
About this study
Official title: Effects of Home Based Step Aerobic Exercises on the Functional Capacity and Physical Performance of Sedentary Young Adults: A Pilot Study
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.
Read the detailed description
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. The primary outcomes to be evaluated are the functional improvements in individuals' balance, functional capacity, muscle strength, and resting heart rate after 6 weeks of step-aerobic exercises. Secondary results are the evaluation of the effects of individuals on jumping performance and exercise motivation. It is thought that the results obtained in the study will reveal new information for studies investigating home-based exercise and rehabilitation practices and may provide evidence for larger studies involving a diagnosis of a disease in the future.
- Conditions
- Aerobic Exercise
- Being tested
- Moderate-intensity aerobic activities
- Keywords
- home-based exercise, step-aerobic exercise, wearable technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-intensity aerobic activitiesOther
The exercise intensity of the individual is planned at 50-60% heart rate reserve using the Karvonen method.
| Study group | Role | What they receive |
|---|---|---|
| Step Aerobic Group | Experimental | Step aerobic exercise Receives: Other: Moderate-intensity aerobic activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
Six minute walk test (6MWT) distance of the participants will be evaluated using the G-Walk sensor system
Measured: 10 weeks
Resting heart rate
Resting heart rate measurements are beats per minute taken in the morning
Measured: 10 weeks
Secondary outcomes (4)
Flamingo Balance Test
Static balances of the subjects will be determined with the Flamingo Balance Test.
Measured: 10 weeks
Quadriceps Strength
Testing will be done at 90 degrees of knee flexion using Mechanical Push/Pull Dynamometer (MPPD) 22 lb (Fabrication Enterprises Inc., USA).
Measured: 10 weeks
Counter movement jump
The jump parameters of the participants will be evaluated using the G-Walk sensor system (BTS G-Walk BTS Bioengineering Company, Italy).
Measured: 10 weeks
Exercise motivation
Motivation will be measured after exercise using a visual analog scale consisting of a 100 mm line. Individuals will mark on the line how motivated they are during exercise. Motivation points will be obtained by measuring the distance from zero to point o
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start30 Dec 2021
- Primary completion10 May 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Kundakçı, Afyonkarahisar Health Sciences University
- Investigators
- Yunus Emre Kundakci, PhD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097196
- Sponsor's protocol ID
- 2021/439
- Status last verified
- May 2023
- First submitted
- 26 Sep 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home Based Step Aerobic Exercises on the Functional Capacity and Physical Performance of Sedentary Young Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT05097196
- Acronym / sponsor ID
- 2021/439
- Conditions
- Aerobic Exercise
- Keywords
- home-based exercise, step-aerobic exercise, wearable technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. The primary outcomes to be evaluated are the functional improvements in individuals' balance, functional capacity, muscle strength, and resting heart rate after 6 weeks of step-aerobic exercises. Secondary results are the evaluation of the effects of individuals on jumping performance and exercise motivation. It is thought that the results obtained in the study will reveal new information for studies investigating home-based exercise and rehabilitation practices and may provide evidence for larger studies involving a diagnosis of a disease in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Step Aerobic Group | Experimental | Other: Moderate-intensity aerobic activitiesStep aerobic exercise |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-intensity aerobic activitiesThe exercise intensity of the individual is planned at 50-60% heart rate reserve using the Karvonen method. | Other | Step Aerobic Group |
Primary outcome
Functional capacity
Time frame: 10 weeks
Six minute walk test (6MWT) distance of the participants will be evaluated using the G-Walk sensor system
Resting heart rate
Time frame: 10 weeks
Resting heart rate measurements are beats per minute taken in the morning
4 secondary outcomes
Flamingo Balance Test
Time frame: 10 weeks
Quadriceps Strength
Time frame: 10 weeks
Counter movement jump
Time frame: 10 weeks
Exercise motivation
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunus Emre Kundakci, PhD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-intensity aerobic activities in people with Aerobic Exercise, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.