Physical FitnessNCT06252896
The Acute Effect Of Instrumental-Assisted Soft Tissue Mobilization Technique on Physical Fitness Parameters
A study testing INSTRUMENTAL-ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUE in people with Physical Fitness, run by Nuh Naci Yazgan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of Instrument Assisted Soft Tissue Mobilization (IASTM) on the acute effects of physical fitness parameters in healthy male individuals. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness
- What is being tested?
- INSTRUMENTAL-ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2022to 27 Jul 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range between 18-25 years,
- Individuals who volunteered to participate in the study were included.
Who cannot join
- Those with diagnosed cardiopulmonary, neurological, orthopedic, psychiatric, skin disease and vestibular diseases,
- Those who have had an acute infection in the last fifteen days
- Individuals who showed and/or were at risk of allergic reactions during ADYDM application were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nuh Naci Yazgan University
Kayseri, Kocasinan/Kayseri, 38090
About this study
Official title: Investigation Of The Acute Effect Of Device-Assisted Soft Tissue Mobilization Technique on Physical Fitness Parameters In Healthy Individuals
The aim of this study is to evaluate the effect of Instrument Assisted Soft Tissue Mobilization (IASTM) on the acute effects of physical fitness parameters in healthy male individuals. 24 volunteers are included in this study who have been divided into two groups such that one part is an IASTM and the other part is a control group. The physical activity levels of the individuals participating in the study were determined using the short form of the International Physical Activity Assessment Questionnaire (IPAQ). Individuals; their aerobic capacity is the Incremental Shuttle Walk Test (ISWT), muscle strength values are digital dynamometer, muscle flexibility values are sit-reach and quadriceps flexibility test, fatigue values are Fatigue Severity Scale (FSS) and Modified Borg Scale, agility assessment is T-Test, and balance assessment is evaluated with a stabilometer device.
Read the detailed description
METHOD
Participants
This study was planned as a randomized, parallel-group clinical trial. A total of 24 individuals, 12 in the IASTM group and 12 in the control group were included in the study. We calculated (G*Power Version 3.1.9.4, Franz Faul, Universitat Kiel, Düsseldorf, Germany) a power of 95% with 0.05 significance, a difference to be detected of 6.88 cm, and a standard deviation of 5.22 cm in hamstring flexibility, generating a sample of 12 individuals per group (Figure 1).
Volunteer individuals aged between 18 and 25 years, who could cooperate with the tests and who did not have any diagnosed orthopedic, cardiac, pulmonary, vestibular, and neurological diseases were included in the study. Those who had an allergic reaction during the IASTM application and those who had an acute infection in the last 15 days were excluded. The data were collected from March 2022 to July 2022.
Randomization This study, which was conducted to examine the acute effect of IASTM on physical fitness parameters, was planned as a randomized controlled parallel trial. The sealed envelope method was used for randomization. The procedure was designed by a researcher who was not involved in other aspects of the protocol. All participants were recruited into groups using pre-numbered, sealed, opaque envelopes.
Materials
First, sociodemographic information of all individuals included in the study was obtained, and all questionnaires were conducted.
Hamstring flexibility measurements of the individuals were performed with a sit-and-reach test using a flexibility bench. Quadriceps flexibility was assessed by placing both hips in a neutral position while the subject lay in the prone position.
The Incremental Shuttle Walk Test (ISWT) was performed to assess the exercise capacity of individuals. The test is set to 10 m between two lines for testing. The individual walks a distance of 10 m around the trip and runs as necessary. At the end of the test, the distance traveled by the individual is recorded. Heart rate, blood pressure, oxygen saturation (Cosmed Spiropalm 6MWT, Milan, Italy), respiratory rate, dyspnea, and fatigue level using the modified Borg Scale were evaluated before and after the ISWT.
Muscle strength was determined by measuring quadriceps and hamstring muscle strength using a digital dynamometer (Jtech Commander Muscle Tester, UT, USA). The mean values of the right and left side measurements were obtained. Then, the average of the measurements of the right and left sides were recorded in Newton (N) using each side.
Agility measurements of the cases were made with T-Test. To apply the T-Test, 4 cones were arranged according to the test and the test was performed. Participants had three repetitions and the best time was recorded.
A stabilometer device (HUR Smartbalance 2031, Kokkola, Finland) used in the study is a balance mechanism that can move forward-backward, right-left, and 3D in the transverse plane. The device's reliability has been demonstrated in different studies.
Fatigue levels of individuals were evaluated using the FSS. Our study used the Turkish version of the FSS.
The short form of the International Physical Activity Questionnaire (IPAQ) was used to assess participants' physical activity levels. Severe, moderate-severe, and walking include seven questions that question the time elapsed while doing these, and sitting time is considered a separate question.
Intervention
In this study, the primary outcome measurements were the quadriceps and hamstring flexibility, and the secondary outcome measurements were exercise capacity, muscle strength, agility, balance, and fatigue. The individuals included in the study were divided into two groups: IASTM and control groups. All measurements were performed on individuals in two groups. Then, in the IASTM group, IASTM was applied to the quadriceps and hamstring muscles of both extremities for five minutes each, for a total of 20 minutes. Immediately afterward, the measurements taken before the intervention were repeated. The control group waited for 30 minutes after the initial measurements and all measurements were repeated.
Statistical analyses
Statistical analyses were performed using SPSS Statistics 25.0 (IBM Inc., Armonk, NY, USA). Descriptive statistics were calculated. The normality of the data was checked using the Kolmogorov-Smirnov test. As appropriate, two independent groups of numerical variables were analyzed using Student's t-test or the Mann-Whitney U-test. The chi-square test was used for categorical comparisons. Baseline values were compared using Student's t-test. A two-way analysis of variance was used to evaluate time and group-time interaction. Repeated measures of variance were analyzed in the data in each session. Within-group changes over time were compared using the Wilcoxon signed-rank test. The descriptive level of significance was set at p<0.05.
- Conditions
- Physical Fitness
- Being tested
- INSTRUMENTAL-ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUE, NO INTERVENTION
- Keywords
- Aerobic Agility, Balance, Capacity, Fatigue, Flexibility, Mobilization
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSTRUMENTAL-ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUEOther
After all evaluations were made, IASTM was applied to the individuals in the intervention group for five minutes each, for a total of 20 minutes, on the quadriceps and hamstring muscles of both extremities, respectively.
NO INTERVENTIONOther
The control group waited for 30 minutes after the initial measurements and all measurements were repeated.
| Study group | Role | What they receive |
|---|---|---|
| IASTM Group | Experimental | Individuals were positioned on the stretcher so that the area to be applied was exposed. ADYDM to be applied to ensure comfortable movement of the instrument on the tissue before application baby oil was applied to cover the area. In order to increase the effectiveness of the application suggestions were made to the person to relax. Application ADYDM for each muscle group tool (Figure 3.4) for 5 minutes. The occurrence of allergic reactions on the skin the test was terminated. Receives: Other: INSTRUMENTAL-ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUE |
| Control Group | Placebo comparator | The control group was kept for 30 minutes without ADYDM application and then muscle strength assessment, flexibility assessment, agility assessment, balance assessment and finally aerobic capacity assessment were performed respectively. Receives: Other: NO INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexibility
Hamstring flexibility measurements of the individuals were performed with a sit-and-reach test using a flexibility bench. Quadriceps flexibility was assessed by placing both hips in a neutral position while the subject lay in the prone position.
Measured: up to six week
Secondary outcomes (5)
Exercise Capacity
Individuals' exercise capacity will be evaluated using the Incremental Shuttle Walk Test (ISWT), a test that measures maximal aerobic capacity. The test is set to 10 m between two lines for testing. The individual walks a distance of 10 m around the trip and runs as necessary. At the end of the test, the distance traveled by the individual is recorded.
Measured: up to six week
Agility
Agility measurements of the cases were made with T-Test. To apply the T-Test, 4 cones were arranged according to the test and the test was performed. Participants had three repetitions and the best time was recorded.
Measured: up to six week
Balance
A stabilometer device (HUR Smartbalance 2031, Kokkola, Finland) used in the study is a balance mechanism that can move forward-backward, right-left, and 3D in the transverse plane. The device's reliability has been demonstrated in different studies.
Measured: up to six week
Muscle Strength
Muscle strength was determined by measuring quadriceps and hamstring muscle strength using a digital dynamometer (Jtech Commander Muscle Tester, UT, USA). The mean values of the right and left side measurements were obtained. Then, the average of the measurements of the right and left sides were recorded in Newton (N) using each side.
Measured: up to six week
Fatique
Fatigue levels of individuals were evaluated using the Fatigue Severity Scale. Our study used the Turkish version of the FSS.
Measured: up to six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start22 Mar 2022
- Primary completion30 May 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FitnessStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuh Naci Yazgan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ukbe Sirayder, Nuh Naci Yazgan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252896
- Sponsor's protocol ID
- 2022/7534Oguz
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2024
- Last updated
- 12 Feb 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 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of The Acute Effect Of Device-Assisted Soft Tissue Mobilization Technique on Physical Fitness Parameters In Healthy Individuals
- ClinicalTrials.gov ID
- NCT06252896
- Acronym / sponsor ID
- 2022/7534Oguz
- Conditions
- Physical Fitness
- Keywords
- Aerobic Agility, Balance, Capacity, Fatigue, Flexibility, Mobilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nuh Naci Yazgan UniversityUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 12 Feb 2024 (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 evaluate the effect of Instrument Assisted Soft Tissue Mobilization (IASTM) on the acute effects of physical fitness parameters in healthy male individuals. 24 volunteers are included in this study who have been divided into two groups such that one part is an IASTM and the other part is a control group. The physical activity levels of the individuals participating in the study were determined using the short form of the International Physical Activity Assessment Questionnaire (IPAQ). Individuals; their aerobic capacity is the Incremental Shuttle Walk Test (ISWT), muscle strength values are digital dynamometer, muscle flexibility values are sit-reach and quadriceps flexibility test, fatigue values are Fatigue Severity Scale (FSS) and Modified Borg Scale, agility assessment is T-Test, and balance assessment is evaluated with a stabilometer device.
Detailed description
METHOD
Participants
This study was planned as a randomized, parallel-group clinical trial. A total of 24 individuals, 12 in the IASTM group and 12 in the control group were included in the study. We calculated (G*Power Version 3.1.9.4, Franz Faul, Universitat Kiel, Düsseldorf, Germany) a power of 95% with 0.05 significance, a difference to be detected of 6.88 cm, and a standard deviation of 5.22 cm in hamstring flexibility, generating a sample of 12 individuals per group (Figure 1).
Volunteer individuals aged between 18 and 25 years, who could cooperate with the tests and who did not have any diagnosed orthopedic, cardiac, pulmonary, vestibular, and neurological diseases were included in the study. Those who had an allergic reaction during the IASTM application and those who had an acute infection in the last 15 days were excluded. The data were collected from March 2022 to July 2022.
Randomization This study, which was conducted to examine the acute effect of IASTM on physical fitness parameters, was planned as a randomized controlled parallel trial. The sealed envelope method was used for randomization. The procedure was designed by a researcher who was not involved in other aspects of the protocol. All participants were recruited into groups using pre-numbered, sealed, opaque envelopes.
Materials
First, sociodemographic information of all individuals included in the study was obtained, and all questionnaires were conducted.
Hamstring flexibility measurements of the individuals were performed with a sit-and-reach test using a flexibility bench. Quadriceps flexibility was assessed by placing both hips in a neutral position while the subject lay in the prone position.
The Incremental Shuttle Walk Test (ISWT) was performed to assess the exercise capacity of individuals. The test is set to 10 m between two lines for testing. The individual walks a distance of 10 m around the trip and runs as necessary. At the end of the test, the distance traveled by the individual is recorded. Heart rate, blood pressure, oxygen saturation (Cosmed Spiropalm 6MWT, Milan, Italy), respiratory rate, dyspnea, and fatigue level using the modified Borg Scale were evaluated before and after the ISWT.
Muscle strength was determined by measuring quadriceps and hamstring muscle strength using a digital dynamometer (Jtech Commander Muscle Tester, UT, USA). The mean values of the right and left side measurements were obtained. Then, the average of the measurements of the right and left sides were recorded in Newton (N) using each side.
Agility measurements of the cases were made with T-Test. To apply the T-Test, 4 cones were arranged according to the test and the test was performed. Participants had three repetitions and the best time was recorded.
A stabilometer device (HUR Smartbalance 2031, Kokkola, Finland) used in the study is a balance mechanism that can move forward-backward, right-left, and 3D in the transverse plane. The device's reliability has been demonstrated in different studies.
Fatigue levels of individuals were evaluated using the FSS. Our study used the Turkish version of the FSS.
The short form of the International Physical Activity Questionnaire (IPAQ) was used to assess participants' physical activity levels. Severe, moderate-severe, and walking include seven questions that question the time elapsed while doing these, and sitting time is considered a separate question.
Intervention
In this study, the primary outcome measurements were the quadriceps and hamstring flexibility, and the secondary outcome measurements were exercise capacity, muscle strength, agility, balance, and fatigue. The individuals included in the study were divided into two groups: IASTM and control groups. All measurements were performed on individuals in two groups. Then, in the IASTM group, IASTM was applied to the quadriceps and hamstring muscles of both extremities for five minutes each, for a total of 20 minutes. Immediately afterward, the measurements taken before the intervention were repeated. The control group waited for 30 minutes after the initial measurements and all measurements were repeated.
Statistical analyses
Statistical analyses were performed using SPSS Statistics 25.0 (IBM Inc., Armonk, NY, USA). Descriptive statistics were calculated. The normality of the data was checked using the Kolmogorov-Smirnov test. As appropriate, two independent groups of numerical variables were analyzed using Student's t-test or the Mann-Whitney U-test. The chi-square test was used for categorical comparisons. Baseline values were compared using Student's t-test. A two-way analysis of variance was used to evaluate time and group-time interaction. Repeated measures of variance were analyzed in the data in each session. Within-group changes over time were compared using the Wilcoxon signed-rank test. The descriptive level of significance was set at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IASTM Group | Experimental | Other: INSTRUMENTAL-ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUEIndividuals were positioned on the stretcher so that the area to be applied was exposed. ADYDM to be applied to ensure comfortable movement of the instrument on the tissue before application baby oil was applied to cover the area. In order to increase the effectiveness of the application suggestions were made to the person to relax. Application ADYDM for each muscle group tool (Figure 3.4) for 5 minutes. The occurrence of allergic reactions on the skin the test was terminated. |
| Control Group | Placebo comparator | Other: NO INTERVENTIONThe control group was kept for 30 minutes without ADYDM application and then muscle strength assessment, flexibility assessment, agility assessment, balance assessment and finally aerobic capacity assessment were performed respectively. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age range between 18-25 years,
- Individuals who volunteered to participate in the study were included.
Key exclusion criteria (3 listed)
- Those with diagnosed cardiopulmonary, neurological, orthopedic, psychiatric, skin disease and vestibular diseases,
- Those who have had an acute infection in the last fifteen days
- Individuals who showed and/or were at risk of allergic reactions during ADYDM application were not included in 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 |
|---|---|---|
| INSTRUMENTAL-ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUEAfter all evaluations were made, IASTM was applied to the individuals in the intervention group for five minutes each, for a total of 20 minutes, on the quadriceps and hamstring muscles of both extremities, respectively. | Other | IASTM Group |
| NO INTERVENTIONThe control group waited for 30 minutes after the initial measurements and all measurements were repeated. | Other | Control Group |
Primary outcome
Flexibility
Time frame: up to six week
Hamstring flexibility measurements of the individuals were performed with a sit-and-reach test using a flexibility bench. Quadriceps flexibility was assessed by placing both hips in a neutral position while the subject lay in the prone position.
5 secondary outcomes
Exercise Capacity
Time frame: up to six week
Agility
Time frame: up to six week
Balance
Time frame: up to six week
Muscle Strength
Time frame: up to six week
Fatique
Time frame: up to six week
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 12 Feb 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 INSTRUMENTAL-ASSISTED SOFT TISSUE MOBILIZATION TECHNIQUE in people with Physical Fitness, run by Nuh Naci Yazgan 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 2 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 12 Feb 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. Some participants in this study may receive a placebo. 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?
Flexibility (time frame: up to six week). 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 12 Feb 2024.