Resistance TrainingNCT06197932
Big Toe Strength Training on Athletic Performance Parameter
A study testing Routine exercise and running training and Big Toe Strengthening Exercise in people with Resistance Training and Athletic Performance, run by Riphah International University at 1 site in Pakistan.
Trial summary
Running form and technique have a direct influence on a runner's economy, and therefore small changes in specific running mechanics could be useful to improving running performance. The thumb plays an important role in the functionality of the foot. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Resistance Training, Athletic Performance, Running
- What is being tested?
- Routine exercise and running training and Big Toe Strengthening Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 25 May 2023to 5 Nov 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 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both gender
- Runners
- Previous history Doing Running practice from 1year for 3-4 days in a week(40-60minutes per day)
Who cannot join
- Any neurological signs.
- Any lower limb trauma or history of fracture past 6 month
- Diabetic, Hypertension
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54770
About this study
Official title: Effects of Big Toe Strength Training on Athletic Performance Parameter in Runners
Running form and technique have a direct influence on a runner's economy, and therefore small changes in specific running mechanics could be useful to improving running performance. The thumb plays an important role in the functionality of the foot. During standing, the big toe is more loaded than the head of the five metatarsals and the heel. In this study, it will aimed to examine the relationship of big toe strength with parameters that affect anaerobic athletic performance in runners. In this study, it will aim to examine the relationship of big toe strength with parameters that affect anaerobic athletic performance in runners such as vertical jump, horizontally jumping, strength, agility and speed.
The study design will be Randomized Controlled Trial. This study will be conducted in Pakistan Sports Board (PSB) Lahore. The study will be completed within the time duration of eight to ten months after the approval of synopsis. Sample size will be 30 subjects. Non-probability convenient sampling technique will be used to recruit the individuals for the study and then randomization will be done by lottery method to divide the individuals into 2 treatment groups. The experimental group is given big toe strengthening program for 4 weeks along with running training on other hand control group will do only their running training and after that measures their pre post values on SPSS 25.
Read the detailed description
Overall performance, particularly in a very popular sports activity such as running, is typically influenced by the status of the musculoskeletal system and the level of training and conditioning of the biological structures. Any change in the musculoskeletal system's biomechanics, especially in the feet and ankles, will strongly influence the biomechanics of runners, possibly predisposing them to injuries. A thorough understanding of the effects of a therapeutic approach focused on feet biomechanics, on the strength and functionality of lower limb muscles will contribute to the adoption of more effective therapeutic and preventive strategies for runners. this study group consists of male runners between the ages of 18-28. The participants will consist of a total of 30 people, 15 of which were in the experimental group and 15 in the control group. Time of the Study: study was determined as 2 days a week for 4 weeks. During this period, exercise with resistance bands to improve the toe strength will apply to the experimental group together with running training. The control group continued their running training and general lower extremity strength during this time Content of the Study: Extension (up) and flexion (down) exercises for the big toe will apply to the experimental group on the thera-band. The exercise will be done in 3 sets and 10-15 repetitions. The athletes got on the platform and performed the exercise according to the instruction of the researcher. The researcher will determine the tempo of the repetition numbers. All participants will command at the same tempo, and the number of repetitions and rest between sets will adjust equally. Measurement of Height: The height measurements of the participants will make with the height measuring device/ inch tape in cm. Measurement of Body Weight: without shoes and clothes (shorts and t-shirts may be allowed) while keeping his/her balance. Weight will measure on a weight machine in kilograms (kg). Measurement of Big Toe Strength: The strength rate of the big toe will take by using the Baseline brand digital display hydraulic pinch meter manufactured in the USA. Athletes placed their feet on the ground prepared in accordance with the big toe and adjust their big toes according to the location of the pinch meter. During the measurement, athletes will ask to apply maximum force with their big toe. Strength measurements will be made on the athletes in the sitting position without any support. Dynamic balance measurements of the participants will take with the Y balance test. To examine the effect of this training on the athletic performance parameters (vertical jump, force, and dynamic balance) were determined. Primary Null Hypothesis: • There is no significant Role of training on the athletic performance parameters (vertical jump, force, and dynamic balance) Primary Alternative Hypothesis: ● There is significant Role of training on the athletic performance parameters (vertical jump, force, and dynamic balance) Beneficiary industry: Runner Athletes The performance measures are underdeveloped for runners in Pakistan. With the help of this instrument runners can measure the toe strength and can increase or decrease the quantity of specific training program. Impact on teaching / training / institutional capability / local industry etc: There is scientific evidence that training with measurements can improve the result and its efficacy so calculated force by toe dynamometer. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Resistance Training, Athletic Performance, Running
- Being tested
- Routine exercise and running training, Big Toe Strengthening Exercise
- Keywords
- Big toe strengthening, Runners, Athletic performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine exercise and running trainingOther
impact of a 4-week running training program on physical performance variables in a control group comprising 15 participants. The control group exclusively underwent running training, and measurements were taken for variables such as the strength of the big toe of both right and left feet using a hip and toe dynamometer (measured in kilograms). Additionally, assessments included vertical jump height and horizontal jump distance (both measured in centimeters), balance using the Y-balance test, and agility via the T-test. All measurements were conducted with standardized equipment, both before and after the training period. se physical performance indicators.
Big Toe Strengthening ExerciseOther
impact of a 4-week intervention involving toe-strengthening exercises and concurrent running training on 15 participants. Pre-assessment measurements included big toe strength, vertical and horizontal jump heights, Y-balance for balance, and T-tests for agility. Following pre-assessment, participants followed a structured toe-strengthening protocol, performing 15 repetitions in three sets twice a day for three weeks. Post-intervention measurements, using the same units and instruments, aim to reveal the effects of the intervention on specified physical variables. This research provides insights into the potential benefits of combining toe-strengthening exercises with running training for enhanced physical performance.
| Study group | Role | What they receive |
|---|---|---|
| Routine exercise and running training | Other | 15 participants were in experimental group giving them Toe strengthening exercise protocol along with running training for three weeks, measure all values before giving them protocol and after protocol. In pre measurements I assessed the strength of big toe of right and left feet, using the hip and toe dynamometer in kilograms. Further I assessed height of vertical jump in centimeters, than I assessed horizontal jump in centimeters. For balance Y -balance test is measured, test is measured for agility T test I measured, after assessment of all variables I gave them plan for big toe strengthening ask them to do repetitions about 15 in three sets twice a day, for 4 weeks after pre measurements, with intensity should be moderate. Asked them to perform 5 exercises twice a day. After 4 weeks measured all variable in same units and used the same instruments that used in pre measurements. Receives: Other: Routine exercise and running training |
| Big Toe Strengthening Exercise | Experimental | Pre-assessment measurements included big toe strength, vertical and horizontal jump heights, Y-balance for balance, and T-tests for agility. Following pre-assessment, participants followed a structured toe-strengthening protocol, performing 15 repetitions in three sets twice a day for 4 weeks. Post-intervention measurements, using the same units and instruments, aim to reveal the effects of the intervention on specified physical variables. This research provides insights into the potential benefits of combining toe-strengthening exercises with running training for enhanced physical performance. Receives: Other: Big Toe Strengthening Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jump
measured by vertical jump
Measured: pre and 4 weeks post intervention
Balance
measured by Y balance test
Measured: pre and 4 weeks post intervention
Strength
measured by Toe/Hip Dynamometer
Measured: pre and 4 weeks post intervention
Agility
measured by T test
Measured: pre and 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start25 May 2023
- Primary completion25 Oct 2023
- Study completion5 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Resistance TrainingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aamir Gul Memon, MS-SPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197932
- Sponsor's protocol ID
- REC/RCR&AHS/22/09
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Denadai BS, Greco CC. Could middle- and long-distance running performance of well-trained athletes be best predicted by the same aerobic parameters? Curr Res Physiol. 2022 Jun 23;5:265-269. doi: 10.1016/j.crphys.2022.06.006. eCollection 2022.
PubMed 35800136Kurihara T, Terada M, Numasawa S, Kusagawa Y, Maeo S, Kanehisa H, Isaka T. Effects of age and sex on association between toe muscular strength and vertical jump performance in adolescent populations. PLoS One. 2021 Dec 31;16(12):e0262100. doi: 10.1371/journal.pone.0262100. eCollection 2021.
PubMed 34972181Yamauchi J, Koyama K. The mechanical role of the metatarsophalangeal joint in human jumping. PLoS One. 2022 May 20;17(5):e0268634. doi: 10.1371/journal.pone.0268634. eCollection 2022.
PubMed 35594285Yamauchi J, Koyama K. Importance of toe flexor strength in vertical jump performance. J Biomech. 2020 May 7;104:109719. doi: 10.1016/j.jbiomech.2020.109719. Epub 2020 Feb 26.
PubMed 32173032Shin H, Moon SW, Kim GS, Park JD, Kim JH, Jung MJ, Yoon CH, Lee ES, Oh MK. Reliability of the pinch strength with digitalized pinch dynamometer. Ann Rehabil Med. 2012 Jun;36(3):394-9. doi: 10.5535/arm.2012.36.3.394. Epub 2012 Jun 30.
PubMed 22837976Dobbs CW, Gill ND, Smart DJ, McGuigan MR. Relationship between vertical and horizontal jump variables and muscular performance in athletes. J Strength Cond Res. 2015 Mar;29(3):661-71. doi: 10.1519/JSC.0000000000000694.
PubMed 25226312
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 Big Toe Strength Training on Athletic Performance Parameter in Runners
- ClinicalTrials.gov ID
- NCT06197932
- Acronym / sponsor ID
- REC/RCR&AHS/22/09
- Conditions
- Resistance Training, Athletic Performance, Running
- Keywords
- Big toe strengthening, Runners, Athletic performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 9 Jan 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.
Running form and technique have a direct influence on a runner's economy, and therefore small changes in specific running mechanics could be useful to improving running performance. The thumb plays an important role in the functionality of the foot. During standing, the big toe is more loaded than the head of the five metatarsals and the heel. In this study, it will aimed to examine the relationship of big toe strength with parameters that affect anaerobic athletic performance in runners. In this study, it will aim to examine the relationship of big toe strength with parameters that affect anaerobic athletic performance in runners such as vertical jump, horizontally jumping, strength, agility and speed.
The study design will be Randomized Controlled Trial. This study will be conducted in Pakistan Sports Board (PSB) Lahore. The study will be completed within the time duration of eight to ten months after the approval of synopsis. Sample size will be 30 subjects. Non-probability convenient sampling technique will be used to recruit the individuals for the study and then randomization will be done by lottery method to divide the individuals into 2 treatment groups. The experimental group is given big toe strengthening program for 4 weeks along with running training on other hand control group will do only their running training and after that measures their pre post values on SPSS 25.
Detailed description
Overall performance, particularly in a very popular sports activity such as running, is typically influenced by the status of the musculoskeletal system and the level of training and conditioning of the biological structures. Any change in the musculoskeletal system's biomechanics, especially in the feet and ankles, will strongly influence the biomechanics of runners, possibly predisposing them to injuries. A thorough understanding of the effects of a therapeutic approach focused on feet biomechanics, on the strength and functionality of lower limb muscles will contribute to the adoption of more effective therapeutic and preventive strategies for runners. this study group consists of male runners between the ages of 18-28. The participants will consist of a total of 30 people, 15 of which were in the experimental group and 15 in the control group. Time of the Study: study was determined as 2 days a week for 4 weeks. During this period, exercise with resistance bands to improve the toe strength will apply to the experimental group together with running training. The control group continued their running training and general lower extremity strength during this time Content of the Study: Extension (up) and flexion (down) exercises for the big toe will apply to the experimental group on the thera-band. The exercise will be done in 3 sets and 10-15 repetitions. The athletes got on the platform and performed the exercise according to the instruction of the researcher. The researcher will determine the tempo of the repetition numbers. All participants will command at the same tempo, and the number of repetitions and rest between sets will adjust equally. Measurement of Height: The height measurements of the participants will make with the height measuring device/ inch tape in cm. Measurement of Body Weight: without shoes and clothes (shorts and t-shirts may be allowed) while keeping his/her balance. Weight will measure on a weight machine in kilograms (kg). Measurement of Big Toe Strength: The strength rate of the big toe will take by using the Baseline brand digital display hydraulic pinch meter manufactured in the USA. Athletes placed their feet on the ground prepared in accordance with the big toe and adjust their big toes according to the location of the pinch meter. During the measurement, athletes will ask to apply maximum force with their big toe. Strength measurements will be made on the athletes in the sitting position without any support. Dynamic balance measurements of the participants will take with the Y balance test. To examine the effect of this training on the athletic performance parameters (vertical jump, force, and dynamic balance) were determined. Primary Null Hypothesis: • There is no significant Role of training on the athletic performance parameters (vertical jump, force, and dynamic balance) Primary Alternative Hypothesis: ● There is significant Role of training on the athletic performance parameters (vertical jump, force, and dynamic balance) Beneficiary industry: Runner Athletes The performance measures are underdeveloped for runners in Pakistan. With the help of this instrument runners can measure the toe strength and can increase or decrease the quantity of specific training program. Impact on teaching / training / institutional capability / local industry etc: There is scientific evidence that training with measurements can improve the result and its efficacy so calculated force by toe dynamometer. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine exercise and running training | Other | Other: Routine exercise and running training15 participants were in experimental group giving them Toe strengthening exercise protocol along with running training for three weeks, measure all values before giving them protocol and after protocol. In pre measurements I assessed the strength of big toe of right and left feet, using the hip and toe dynamometer in kilograms. Further I assessed height of vertical jump in centimeters, than I assessed horizontal jump in centimeters. For balance Y -balance test is measured, test is measured for agility T test I measured, after assessment of all variables I gave them plan for big toe strengthening ask them to do repetitions about 15 in three sets twice a day, for 4 weeks after pre measurements, with intensity should be moderate. Asked them to perform 5 exercises twice a day. After 4 weeks measured all variable in same units and used the same instruments that used in pre measurements. |
| Big Toe Strengthening Exercise | Experimental | Other: Big Toe Strengthening ExercisePre-assessment measurements included big toe strength, vertical and horizontal jump heights, Y-balance for balance, and T-tests for agility. Following pre-assessment, participants followed a structured toe-strengthening protocol, performing 15 repetitions in three sets twice a day for 4 weeks. Post-intervention measurements, using the same units and instruments, aim to reveal the effects of the intervention on specified physical variables. This research provides insights into the potential benefits of combining toe-strengthening exercises with running training for enhanced physical performance. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both gender
- Runners
- Previous history Doing Running practice from 1year for 3-4 days in a week(40-60minutes per day)
Key exclusion criteria (3 listed)
- Any neurological signs.
- Any lower limb trauma or history of fracture past 6 month
- Diabetic, Hypertension
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 |
|---|---|---|
| Routine exercise and running trainingimpact of a 4-week running training program on physical performance variables in a control group comprising 15 participants. The control group exclusively underwent running training, and measurements were taken for variables such as the strength of the big toe of both right and left feet using a hip and toe dynamometer (measured in kilograms). Additionally, assessments included vertical jump height and horizontal jump distance (both measured in centimeters), balance using the Y-balance test, and agility via the T-test. All measurements were conducted with standardized equipment, both before and after the training period. se physical performance indicators. | Other | Routine exercise and running training |
| Big Toe Strengthening Exerciseimpact of a 4-week intervention involving toe-strengthening exercises and concurrent running training on 15 participants. Pre-assessment measurements included big toe strength, vertical and horizontal jump heights, Y-balance for balance, and T-tests for agility. Following pre-assessment, participants followed a structured toe-strengthening protocol, performing 15 repetitions in three sets twice a day for three weeks. Post-intervention measurements, using the same units and instruments, aim to reveal the effects of the intervention on specified physical variables. This research provides insights into the potential benefits of combining toe-strengthening exercises with running training for enhanced physical performance. | Other | Big Toe Strengthening Exercise |
Primary outcome
Jump
Time frame: pre and 4 weeks post intervention
measured by vertical jump
Balance
Time frame: pre and 4 weeks post intervention
measured by Y balance test
Strength
Time frame: pre and 4 weeks post intervention
measured by Toe/Hip Dynamometer
Agility
Time frame: pre and 4 weeks post intervention
measured by T test
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.
- Background: PubMed 35800136Denadai BS, Greco CC. Could middle- and long-distance running performance of well-trained athletes be best predicted by the same aerobic parameters? Curr Res Physiol. 2022 Jun 23;5:265-269. doi: 10.1016/j.crphys.2022.06.006. eCollection 2022.
- Background: PubMed 34972181Kurihara T, Terada M, Numasawa S, Kusagawa Y, Maeo S, Kanehisa H, Isaka T. Effects of age and sex on association between toe muscular strength and vertical jump performance in adolescent populations. PLoS One. 2021 Dec 31;16(12):e0262100. doi: 10.1371/journal.pone.0262100. eCollection 2021.
- Background: PubMed 35594285Yamauchi J, Koyama K. The mechanical role of the metatarsophalangeal joint in human jumping. PLoS One. 2022 May 20;17(5):e0268634. doi: 10.1371/journal.pone.0268634. eCollection 2022.
- Background: PubMed 32173032Yamauchi J, Koyama K. Importance of toe flexor strength in vertical jump performance. J Biomech. 2020 May 7;104:109719. doi: 10.1016/j.jbiomech.2020.109719. Epub 2020 Feb 26.
- Background: PubMed 22837976Shin H, Moon SW, Kim GS, Park JD, Kim JH, Jung MJ, Yoon CH, Lee ES, Oh MK. Reliability of the pinch strength with digitalized pinch dynamometer. Ann Rehabil Med. 2012 Jun;36(3):394-9. doi: 10.5535/arm.2012.36.3.394. Epub 2012 Jun 30.
- Background: PubMed 25226312Dobbs CW, Gill ND, Smart DJ, McGuigan MR. Relationship between vertical and horizontal jump variables and muscular performance in athletes. J Strength Cond Res. 2015 Mar;29(3):661-71. doi: 10.1519/JSC.0000000000000694.
- 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.
Aamir Gul Memon, MS-SPT principal investigator
Riphah International 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 Routine exercise and running training and Big Toe Strengthening Exercise in people with Resistance Training and Athletic Performance, run by Riphah International University at 1 site in Pakistan.
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 3 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 Pakistan. 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?
Jump (time frame: pre and 4 weeks post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06197932, which also lists 6 linked publications.
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.