Sedentary Healthy Young IndividualsNCT04910035
The Effect of Square Stepping Exercises Training on Lower Extremity
A study testing Exercises Training in people with Sedentary Healthy Young Individuals, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
Physical activity plays an indispensable role to lead a healthy life. Square-stepping exercises (SSE) are aerobic exercises.Our study was designed to investigate the effects of square-stepping exercise training on lower-extremity motor performance, muscle strength, and muscle quality of sedentary healthy young… Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Healthy Young Individuals
- What is being tested?
- Exercises Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2019to 10 May 2020
- 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 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-25 years old,
- Not attending any exercise program for the last 1 year,
- Not having a neurological, orthopedic disease or any disease affecting lower extremity,
- Not having any lower-extremity surgery,
- Individuals without vision and/or hearing problems were included in the study.
Who cannot join
- Having a vision and/or hearing problem,
- Having neurological, psychiatric, and/or orthopedic problems that affect walking,
- Individuals with lower-extremity surgery were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nigde Omer Halisdemir University
Niğde, Bor, 51200
About this study
Official title: The Effect of Square Stepping Exercises Training on Lower Extremity Motor Performance, Muscle Strenght and Muscle Quality in Healthy Young People: a Single-Blind, Randomized, Controlled Clinical Trial
Physical activity plays an indispensable role to lead a healthy life. Square-stepping exercises (SSE) are aerobic exercises.Our study was designed to investigate the effects of square-stepping exercise training on lower-extremity motor performance, muscle strength, and muscle quality of sedentary healthy young individuals.
Read the detailed description
A total of 120 volunteers within the age range of 20-25 participated in the research. Participants were randomly divided into two groups, as 60 participants were study group (35 females, 25 males) and 60 participants were control group (35 females, 25 males). Demographic data and exercise habit of the individuals were documented. Participants' lower-extremity motor performance was analyzed through Vertical Jumping, Side Jumping, One Leg Squat, and Step-Up tests. Participants' muscle strength was analyzed through Hand-Held Dynamometer. Also, participants' muscle quality was analyzed through Muscle Quality Index. Throughout 3 weeks SSE training was administered 4 days a week for a length of 45 minutes in each session. All the analyses were conducted at the start and at the end of 3-week long training
- Conditions
- Sedentary Healthy Young Individuals
- Being tested
- Exercises Training
- Keywords
- Square-stepping exercises, Healthy young individuals, Motor performance, Muscle strength, Muscle quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises TrainingOther
Also called Square-steeping exercise
SSE is performed on a thin exercise mat divided into 40 small squares in 250 cm x 100 cm of size (25 cm each part). Participants are given patterns of a few steps and asked to take steps that match them. Participants must, in principal, move ahead in line with the length forward with no contact on the lines forming the squares. Forward, backward, lateral and oblique stepping patterns are required. Stepping patterns get increasingly difficult. Each pattern consists of 2 to 16 steps; participants are asked to repeat step pattern till the end of exercise mat. Upon completing a pattern, another pattern in the same mirror-image is repeated. In essence each pattern is reiterated for 3-5 times and next its mirror-image pattern is repeated but if participants face challenge in performing the pattern it is repeated till the pattern is learnt
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Active comparator | Throughout 3 weeks SSE training was administered 4 days a week for a length of 45 minutes in each session. All the analyses were conducted at the start and at the end of 3-week long training. Receives: Other: Exercises Training |
| Control Group | No intervention | This group has no intervention. Evaluations were only made at the start and at the end of 3-week long. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Quality İndex
Muscle quality was determined through Muscle Quality Index (MQI) which is a valid and reliable method developed by Takai et al. MQI measures 5 repetition sit-to-stand test duration (sec). MQI is calculated by measuring the 5-repetition sit-to-go test duration (sec), body weight (kg), and leg length (L-m). In the calculation, the formula "(L-0,5)*5*weight*g/5" repetitions sit-to-stand test duration is employed.
Measured: 3 weeks
Muscle Strength
Hand-Held Dynamometer
Measured: 3 weeks
Motor Performance Assessment 1
Vertical Jumping
Measured: 3 weeks
Motor Performance Assessment 2
Step-Up
Measured: 3 weeks
Motor Performance Assessment 3
One Leg Squat
Measured: 3 weeks
Motor Performance Assessment 4
Side Jumping
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start10 Sep 2019
- Primary completion10 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary Healthy Young IndividualsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Asli Demirtaş, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910035
- Sponsor's protocol ID
- (11.06.2019-11)
- Status last verified
- Jun 2021
- First submitted
- 4 May 2021
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Square Stepping Exercises Training on Lower Extremity Motor Performance, Muscle Strenght and Muscle Quality in Healthy Young People: a Single-Blind, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04910035
- Acronym / sponsor ID
- (11.06.2019-11)
- Conditions
- Sedentary Healthy Young Individuals
- Keywords
- Square-stepping exercises, Healthy young individuals, Motor performance, Muscle strength, Muscle quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 2 Jun 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.
Physical activity plays an indispensable role to lead a healthy life. Square-stepping exercises (SSE) are aerobic exercises.Our study was designed to investigate the effects of square-stepping exercise training on lower-extremity motor performance, muscle strength, and muscle quality of sedentary healthy young individuals.
Detailed description
A total of 120 volunteers within the age range of 20-25 participated in the research. Participants were randomly divided into two groups, as 60 participants were study group (35 females, 25 males) and 60 participants were control group (35 females, 25 males). Demographic data and exercise habit of the individuals were documented. Participants' lower-extremity motor performance was analyzed through Vertical Jumping, Side Jumping, One Leg Squat, and Step-Up tests. Participants' muscle strength was analyzed through Hand-Held Dynamometer. Also, participants' muscle quality was analyzed through Muscle Quality Index. Throughout 3 weeks SSE training was administered 4 days a week for a length of 45 minutes in each session. All the analyses were conducted at the start and at the end of 3-week long training
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Active comparator | Other: Exercises TrainingThroughout 3 weeks SSE training was administered 4 days a week for a length of 45 minutes in each session. All the analyses were conducted at the start and at the end of 3-week long training. |
| Control Group | No intervention | –This group has no intervention. Evaluations were only made at the start and at the end of 3-week long. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 20-25 years old,
- Not attending any exercise program for the last 1 year,
- Not having a neurological, orthopedic disease or any disease affecting lower extremity,
- Not having any lower-extremity surgery,
- Individuals without vision and/or hearing problems were included in the study.
Key exclusion criteria (3 listed)
- Having a vision and/or hearing problem,
- Having neurological, psychiatric, and/or orthopedic problems that affect walking,
- Individuals with lower-extremity surgery were excluded from the study.
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 |
|---|---|---|
| Exercises TrainingAlso: Square-steeping exerciseSSE is performed on a thin exercise mat divided into 40 small squares in 250 cm x 100 cm of size (25 cm each part). Participants are given patterns of a few steps and asked to take steps that match them. Participants must, in principal, move ahead in line with the length forward with no contact on the lines forming the squares. Forward, backward, lateral and oblique stepping patterns are required. Stepping patterns get increasingly difficult. Each pattern consists of 2 to 16 steps; participants are asked to repeat step pattern till the end of exercise mat. Upon completing a pattern, another pattern in the same mirror-image is repeated. In essence each pattern is reiterated for 3-5 times and next its mirror-image pattern is repeated but if participants face challenge in performing the pattern it is repeated till the pattern is learnt | Other | Training Group |
Primary outcome
Muscle Quality İndex
Time frame: 3 weeks
Muscle quality was determined through Muscle Quality Index (MQI) which is a valid and reliable method developed by Takai et al. MQI measures 5 repetition sit-to-stand test duration (sec). MQI is calculated by measuring the 5-repetition sit-to-go test duration (sec), body weight (kg), and leg length (L-m). In the calculation, the formula "(L-0,5)*5*weight*g/5" repetitions sit-to-stand test duration is employed.
Muscle Strength
Time frame: 3 weeks
Hand-Held Dynamometer
Motor Performance Assessment 1
Time frame: 3 weeks
Vertical Jumping
Motor Performance Assessment 2
Time frame: 3 weeks
Step-Up
Motor Performance Assessment 3
Time frame: 3 weeks
One Leg Squat
Motor Performance Assessment 4
Time frame: 3 weeks
Side Jumping
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 3 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises Training in people with Sedentary Healthy Young Individuals, run by Nigde Omer Halisdemir 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 5 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 3 Sep 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?
Muscle Quality İndex (time frame: 3 weeks). The study lists 6 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 3 Sep 2024.