HealthyNCT05426772
Investigation of the Effect of Kinesiotape Applied With Exercise on Muscle Oxygenation With Moxy Muscle Oxygen Monitor
A study testing exercise and kinesiotaping in people with Healthy and Sedentary, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
Kinesio taping (KT) is an elastic adhesive tape with physiological effects, often used in rehabilitation and sports medicine. KT, which can stay in the body for 3 to 5 days, exerts a pulling force on the skin thanks to its wave-like structure and elasticity, and increases the gap between the subcutaneous soft tissue… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- What is being tested?
- exercise and kinesiotaping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2021to 2 May 2023
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the study
- Being between the ages of 18-40
- Being sedentary (<600 MET-min/week according to the International Physical Activity Questionnaire Short Form)
- BMI <30kg/cm2
- Subcutaneous fat thickness <12mm
Who cannot join
- Having an open wound or infection in the application area
- Having a chronic illness
- Being pregnant
- Having a psychological disorder
- Having a lower extremity injury in the last 6 months
- Having had any surgical operation involving the lower extremity in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma Onyedi Eylül University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Balıkesir, Bandırma
About this study
Kinesio taping (KT) is an elastic adhesive tape with physiological effects, often used in rehabilitation and sports medicine. KT, which can stay in the body for 3 to 5 days, exerts a pulling force on the skin thanks to its wave-like structure and elasticity, and increases the gap between the subcutaneous soft tissue and fascia with its lifting effect. In this way, it reduces the superficial pressure and causes an increase in lymph circulation. In addition, with the effect it creates on the muscles, it allows maximum contraction and relaxation of the muscle and creates positive effects on the deep lymphatics. Another effective approach to increase blood circulation is exercise. Exercise, which is known to have many benefits, has been shown to increase both systemic circulation and muscle blood flow. There are findings in the literature that KT can increase the effectiveness of exercise, but it has been stated that this issue is not clear and more studies are needed. In order to evaluate the effects of KT on increasing the effectiveness of exercise and on circulation, the oxygen saturation of the muscle in the application area can be measured. As a matter of fact, "Moxy muscle oxygen monitor" has been used in the literature, which measures regional oxygen saturation (SmO2) and total hemoglobin (THb) in capillaries under the muscle. The Moxy muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21 mm) device that measures regional blood flow and oxygenation by placing it on the skin non-invasively with near-infrared spectroscopy (NIRS). Its validity in measuring muscle oxygenation was vigorous or fairly good, and its reliability was found to be moderate to high in low-intensity exercises (SROC: r = 0.842-0.993, ICC: r = 0.773-0.992, p < .01). It is thought that the application of KT, which is known to increase lymphatic and venous circulation, together with exercise will increase the amount of oxygen in the muscles. To the best of our knowledge in the literature, no study has been found in which this effect of KT is presented objectively. For this reason, it is aimed to examine muscle oxygenation with the Moxy muscle oxygen monitor, which provides objective data on KT applied with exercise.
- Being tested
- exercise and kinesiotaping
- Keywords
- muscle oxygen, kinesio taping, near infrared spectroscopy, exercise
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and kinesiotapingOther
Exercise: Aerobic exercise will be performed on the treadmill for 20 minutes with a maximum heart rate of 55%-65% and a perceived exertion of less than 3. The Moxy muscle oxygen monitor will take measurements over the quadriceps femoris muscle at this time.
Kinesiotaping: After 3 days, the same participants will be called for kinesiotaping application. The application will be applied to the quadriceps femoris muscle with the facilitation technique by a physiotherapist who has a kinesio taping training certificate.
| Study group | Role | What they receive |
|---|---|---|
| Healthy sedentary people | Other | Muscle oxygenation and vital signs will be measured before, during, and after of 20 minutes aerobic exercise in an environment where suitable conditions are provided. After 3 days, kinesio taping will be added to the same program and the measurements will be repeated. Receives: Other: exercise and kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moxy Muscle Oxygen Monitor
The Moxy muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21 mm) device that measures regional blood flow and oxygenation by placing it on the skin non-invasively with near infrared spectroscopy (NIRS). The device, which has data collection and telemetric features, also allows O2 measurement in non-laboratory environments and field-based research. Compared to other NIRS devices, the Moxy muscle oxygen monitor has been shown to be a valid and reliable device for muscle oxygenation. Its validity in measuring muscle oxygenation was strong or very good, and its reliability was found to be moderate to high in low-intensity exercises (SROC: r = 0.842-0.993, ICC: r = 0.773-0.992, p < .01). It has been reported that as exercise intensity increases, its reliability changes inversely.
Measured: Baseline
Moxy Muscle Oxygen Monitor
The Moxy muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21 mm) device that measures regional blood flow and oxygenation by placing it on the skin non-invasively with near infrared spectroscopy (NIRS). The device, which has data collection and telemetric features, also allows O2 measurement in non-laboratory environments and field-based research. Compared to other NIRS devices, the Moxy muscle oxygen monitor has been shown to be a valid and reliable device for muscle oxygenation. Its validity in measuring muscle oxygenation was strong or very good, and its reliability was found to be moderate to high in low-intensity exercises (SROC: r = 0.842-0.993, ICC: r = 0.773-0.992, p < .01). It has been reported that as exercise intensity increases, its reliability changes inversely.
Measured: fourth day
Secondary outcomes (2)
heart rate
heart rate will be evaluated with pulse oximetry
Measured: Baseline
heart rate
heart rate will be evaluated with pulse oximetry
Measured: fourth day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start16 Sep 2021
- Primary completion1 Mar 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Nur YILMAZ, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426772
- Sponsor's protocol ID
- 2020-60
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2022
- Last updated
- 4 Jun 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 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Kinesiotape Applied With Exercise on Muscle Oxygenation With Moxy Muscle Oxygen Monitor
- ClinicalTrials.gov ID
- NCT05426772
- Acronym / sponsor ID
- 2020-60
- Keywords
- muscle oxygen, kinesio taping, near infrared spectroscopy, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 22 Jun 2022 (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.
Kinesio taping (KT) is an elastic adhesive tape with physiological effects, often used in rehabilitation and sports medicine. KT, which can stay in the body for 3 to 5 days, exerts a pulling force on the skin thanks to its wave-like structure and elasticity, and increases the gap between the subcutaneous soft tissue and fascia with its lifting effect. In this way, it reduces the superficial pressure and causes an increase in lymph circulation. In addition, with the effect it creates on the muscles, it allows maximum contraction and relaxation of the muscle and creates positive effects on the deep lymphatics. Another effective approach to increase blood circulation is exercise. Exercise, which is known to have many benefits, has been shown to increase both systemic circulation and muscle blood flow. There are findings in the literature that KT can increase the effectiveness of exercise, but it has been stated that this issue is not clear and more studies are needed. In order to evaluate the effects of KT on increasing the effectiveness of exercise and on circulation, the oxygen saturation of the muscle in the application area can be measured. As a matter of fact, "Moxy muscle oxygen monitor" has been used in the literature, which measures regional oxygen saturation (SmO2) and total hemoglobin (THb) in capillaries under the muscle. The Moxy muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21 mm) device that measures regional blood flow and oxygenation by placing it on the skin non-invasively with near-infrared spectroscopy (NIRS). Its validity in measuring muscle oxygenation was vigorous or fairly good, and its reliability was found to be moderate to high in low-intensity exercises (SROC: r = 0.842-0.993, ICC: r = 0.773-0.992, p < .01). It is thought that the application of KT, which is known to increase lymphatic and venous circulation, together with exercise will increase the amount of oxygen in the muscles. To the best of our knowledge in the literature, no study has been found in which this effect of KT is presented objectively. For this reason, it is aimed to examine muscle oxygenation with the Moxy muscle oxygen monitor, which provides objective data on KT applied with exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy sedentary people | Other | Other: exercise and kinesiotapingMuscle oxygenation and vital signs will be measured before, during, and after of 20 minutes aerobic exercise in an environment where suitable conditions are provided. After 3 days, kinesio taping will be added to the same program and the measurements will be repeated. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteering to participate in the study
- Being between the ages of 18-40
- Being sedentary (<600 MET-min/week according to the International Physical Activity Questionnaire Short Form)
- BMI <30kg/cm2
- Subcutaneous fat thickness <12mm
Key exclusion criteria (6 listed)
- Having an open wound or infection in the application area
- Having a chronic illness
- Being pregnant
- Having a psychological disorder
- Having a lower extremity injury 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 |
|---|---|---|
| exercise and kinesiotapingExercise: Aerobic exercise will be performed on the treadmill for 20 minutes with a maximum heart rate of 55%-65% and a perceived exertion of less than 3. The Moxy muscle oxygen monitor will take measurements over the quadriceps femoris muscle at this time. Kinesiotaping: After 3 days, the same participants will be called for kinesiotaping application. The application will be applied to the quadriceps femoris muscle with the facilitation technique by a physiotherapist who has a kinesio taping training certificate. | Other | Healthy sedentary people |
Primary outcome
Moxy Muscle Oxygen Monitor
Time frame: Baseline
The Moxy muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21 mm) device that measures regional blood flow and oxygenation by placing it on the skin non-invasively with near infrared spectroscopy (NIRS). The device, which has data collection and telemetric features, also allows O2 measurement in non-laboratory environments and field-based research. Compared to other NIRS devices, the Moxy muscle oxygen monitor has been shown to be a valid and reliable device for muscle oxygenation. Its validity in measuring muscle oxygenation was strong or very good, and its reliability was found to be moderate to high in low-intensity exercises (SROC: r = 0.842-0.993, ICC: r = 0.773-0.992, p < .01). It has been reported that as exercise intensity increases, its reliability changes inversely.
Moxy Muscle Oxygen Monitor
Time frame: fourth day
The Moxy muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21 mm) device that measures regional blood flow and oxygenation by placing it on the skin non-invasively with near infrared spectroscopy (NIRS). The device, which has data collection and telemetric features, also allows O2 measurement in non-laboratory environments and field-based research. Compared to other NIRS devices, the Moxy muscle oxygen monitor has been shown to be a valid and reliable device for muscle oxygenation. Its validity in measuring muscle oxygenation was strong or very good, and its reliability was found to be moderate to high in low-intensity exercises (SROC: r = 0.842-0.993, ICC: r = 0.773-0.992, p < .01). It has been reported that as exercise intensity increases, its reliability changes inversely.
2 secondary outcomes
heart rate
Time frame: Baseline
heart rate
Time frame: fourth day
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 4 Jun 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 exercise and kinesiotaping in people with Healthy and Sedentary, run by Bandırma Onyedi Eylül 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 6 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 4 Jun 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?
Moxy Muscle Oxygen Monitor (time frame: Baseline). 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 4 Jun 2024.