- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05514392
The Effect of Bicycle Ergometer Training on Balance and Emg Activity
August 25, 2022 updated by: Saglik Bilimleri Universitesi
Comparison of Electromyographic Threshold and Dynamic Balance After Single Leg Cycling Ergometer and Double Leg Cycling Ergometer Training in Healthy Adults
The study will contribute to answering the question of 'in which exercise types of single-leg and double-leg exercise protocols will affect whether fatigue occurs early or not, and muscle activations will occur.
In response to this question, clinicians will prefer to focus on which type of exercise produces more muscle activation and late fatigue.
Few studies have been done on single and double leg bicycle ergometers in the literature.
From these studies; While examining the lactate and EMG threshold values after cycling ergometer training, another study compared the effectiveness of single and double leg cycling ergometers.
In the literature, EMG and dynamic balance were not used in the comparison after single and double leg bicycle ergometer training.
In this study, the effectiveness of single and double legged bicycle ergometers will be compared by looking at EMG and dynamic balance changes.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
In humans, one side of the body is often preferred over the other to perform voluntary motor actions.
There is evidence that in bipedal cycling training, where both legs are simultaneously involved in the motor task, the dominant leg contributes more to the power produced than the non-dominant leg.
The magnitude of asymmetries between both legs can vary (eg 1-40%) and depend on the variable of interest (eg power, torque, etc.), pedaling phase, intensity and cadence.
Bicycle ergometer leg exercise has been applied in the literature as an assessment tool for motor function, aerobic training method and also for individuals.
Cycling performance depends on the optimization of physiological, psychological and biomechanical parameters.
There are already many studies on physiological or psychological performance parameters.
The pedaling paradigm has many advantages.
It minimizes postural control, is characterized by a restricted kinematic trajectory, requires less effort for training control, and shares a similar muscle activation pattern with walking.
EMG is an indirect measure of muscle activity as it detects the electrical activity produced by the passage of a nerve impulse that causes an action potential in the muscle cell membrane.
This potential consists of three phases: membrane depolarization, repolarization, and hyperpolarization period, which produces an electric field picked up by the EMG electrodes.
Decomposition techniques have been applied to EMG signals to identify motor patterns of joint activation between muscle groups, called motor modules or muscle synergies.
Each synergy is represented by a spatial component that reflects the composition of muscle co-activation and a temporal component that elicits modulus uptake throughout the execution of the movement.
Successfully applied to different motor behaviors, this analysis supports the hypothesis of a low-dimensional modular organization at the central nervous system level.
Muscle electrical activity is measured using electromyography (EMG).
The amplitude of the EMG signal has a monotonic relationship with the number of activated muscle fibers and is therefore a good indicator of contraction intensity.
In dynamic studies, the signals reaching the motor unit, which can be detected at the location of the electrode, overlap electrically and are observed as a bipolar signal with symmetrical negative and positive amplitude distribution.
The signal obtained without filtering is called the "Raw signal", which consists of periods of contraction and relaxation.
During the rest period, the baseline EMG is observed, which depends on many factors (quality of the amplifier, environmental noise, and the quality of the given sensing condition) and should not exceed line 3 if these factors are within appropriate limits.
5 microvolts (mV).
During normal bipedal bicycle pedaling, when the leg extensor muscles are active during the first half of the 360̊ crank cycle, crank torque is mainly produced in the down phase of each leg while pedaling.
For training and rehabilitation purposes, they sometimes engage in 1-leg pedaling with crank torque produced by only one leg, emphasizing the need for ipsilateral flexor activity in the upward movement of the foot to produce crank torque while pedaling and produce a smooth pedaling motion throughout.
the entire crank cycle.
Therefore, single-leg pedaling requires cyclists to change how they control.
multiple extensor and flexor leg muscles during the crank cycle.
Therefore, the 1-leg bike has been proposed as a training tool to improve pedaling performance and is used in clinical settings for rehabilitation.
EMG studies with bicycle ergometer are insufficient in the literature.
During this activity, there is no study in the literature comparing single-leg and double-leg exercises during single-leg cycling exercise, which is frequently used to prevent premature fatigue in leg muscles in chronic obstructive pulmonary patients.
Although ergometer exercise is frequently used in rehabilitation treatment, it increases maximum oxygen uptake and muscle strength, decreases systolic and diastolic blood pressures, decreases body weight and body fat, improves cognitive function, balance function and muscle activity in the literature is limited.
This study will contribute to answering this question that the exercise types of single-leg and double-leg exercise protocols will affect whether muscle activations occur early or not.
In response to this question, clinicians will prefer to focus on which type of exercise produces more muscle activation and late fatigue.
There have been a few studies in the literature on single and double leg bicycle ergometers.
From these studies; Looking at the lactate and EMG threshold values after cycling ergometer training, another study compared the effectiveness of a single ergometer.
Study Type
Observational
Enrollment (Anticipated)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey
- Recruiting
- Sağlık Bilimleri Üniversitesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy adult
Description
Inclusion Criteria:
- Volunteering to participate in the study
- Absence of comorbid disease of orthopedic, neurological, cardiopulmonary system
- Participants who have not participated in another clinical trial in the last 1 month
- Participants with a Body Mass Index (BMI) below 30 kg/m2
Exclusion Criteria:
- Participants who had hip, pelvis, knee, ankle surgery in the last year
- Participants with leg length inequality
- Those with known balance disorders in the last three months due to vestibular disorders, pregnancy, concussion participants
- Participants taking any medication that may affect alertness or balance.
- During the study protocol, the participants did not comply with the requested requests.
- Presence of peripheral nerve dysfunctions and neurological disorders
- Presence of a previous injury to the feet or legs
- Prior surgery on the lower extremities
- Systemic discomfort
- Pain and other medical conditions that may affect postural control
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Receiving Single Leg Cycling Ergometer Training
First of all, an initial warm-up will be done with 40 watts of exercise intensity for 3 minutes.
Exercise will be started with 80 watts of exercise intensity and will be increased by 40 watts every 3 minutes.
Cycling cadence will be determined as a pedaling speed of 80 revolutions per minute and patients will be asked to keep their dominant leg on the pedal and keep their non-dominant leg on the ground.
The exercise protocol will consist of 2 sets as 15 minutes of exercise + 1 minute of break + 15 minutes of exercise.
During the exercise, the heart rate and oxygen saturation of the participants will be monitored by finger pulse oximetry.
EMG measurements were taken at the beginning and end of the ergometer training.
|
Participants will sign a consent form approved by the ethics committee.
Height, weight, thigh length, leg length, foot length and kinematic foot length will be recorded before data collection.
Ergometer positions will be adjusted according to participant preference.
Participants will be invited to the Health Sciences University Physiotherapy and Rehabilitation Hall once.
Before starting the exercise of the participants, muscle activity, balance assessment, leg fatigue will be evaluated.
Participants will be made an exercise protocol.
At the end of the exercise, necessary evaluations will be made again, and then the person will rest for 1 hour.
After 1 hour, the exercise groups will change; Persons receiving single foot bicycle ergometer training will receive double foot bicycle ergometer training, and the group receiving double foot bicycle ergometer training will receive single foot bicycle ergometer training.
Necessary evaluations will be repeated at the end of the training.
|
|
Receiving Double Leg Cycling Ergometer Training
First, a 3-minute initial warm-up will be done with an exercise intensity of 40 watts.
The workout will begin with an exercise intensity of 80 watts and increase by 40 watts every 3 minutes.
Cycling cadence will be determined as a pedaling rate of 80 revolutions per minute and patients will be asked to pedal with both legs.
The exercise protocol will consist of 2 sets of 15 minutes of exercise + 1 minute of break + 15 minutes of exercise.
During the exercise, the heart rate and oxygen saturation of the participants will be monitored by finger pulse oximetry.
EMG measurements were taken at the beginning and end of the ergometer training.
|
Participants will sign a consent form approved by the ethics committee.
Height, weight, thigh length, leg length, foot length and kinematic foot length will be recorded before data collection.
Ergometer positions will be adjusted according to participant preference.
Participants will be invited to the Health Sciences University Physiotherapy and Rehabilitation Hall once.
Before starting the exercise of the participants, muscle activity, balance assessment, leg fatigue will be evaluated.
Participants will be made an exercise protocol.
At the end of the exercise, necessary evaluations will be made again, and then the person will rest for 1 hour.
After 1 hour, the exercise groups will change; Persons receiving single foot bicycle ergometer training will receive double foot bicycle ergometer training, and the group receiving double foot bicycle ergometer training will receive single foot bicycle ergometer training.
Necessary evaluations will be repeated at the end of the training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Superficial Electromyographic (EMG) Measurement
Time Frame: Change from baseline emg values in 30 minutes
|
In the dominant lower extremity to evaluate muscle activity, rectus femoris, surface EMG signals will be recorded with the Trigno Avanti Wireless Surface EMG System.
While the participant is standing in hip neutral and knee extension, the adhesive EMG electrode will be placed on the reference motor point.
Superficial EMG values will be recorded throughout the exercise.
During the research, EMG will be recorded from the stimulated muscles by applying two electrodes to the skin for each muscle.
The amplitude, duration and shape of the evoked muscle action potentials obtained will be reflected as a result.
The amplitudes of the EMG signals will be evaluated.
The method to be used when evaluating EMG signal amplitudes will be the raw EMG calculation.
While evaluating the data, the computer package programs will benefit.
|
Change from baseline emg values in 30 minutes
|
|
Static-Dynamic Balance Evaluation with Isokinetic Balance Device
Time Frame: Change from baseline static and dynamic balance values in 30 minutes
|
Static and dynamic balance performances will be evaluated using the isokinetic balance measurement system.
In this system, there is a sensor in the center of the platform that detects every angular movement and sends the information directly to the computer.
For the static balance test, it will be ensured that they stand on both feet and on the right/left foot with eyes open (EO) and eyes closed (EC), respectively.
The arms are positioned next to the body.
Between each test measurement lasting 20 seconds, approximately 40 seconds of rest will be given.
For the dynamic balance test, the difficulty level of the test will be set to "20".
In the test, they will be asked to circle clockwise 5 times in 60 seconds without bending their knees within the limited area on the computer screen.
The Patient Record database module enables the creation of clinical cards for each case.
It facilitates the comparison of each case's own tests.
|
Change from baseline static and dynamic balance values in 30 minutes
|
|
Static Balance Evaluation with One Leg Standing Balance Test
Time Frame: Change from baseline static balance values in 30 minutes
|
This test will be used to evaluate balance status in our study.
During the application, the person raises one foot while standing.
From this moment on, the time is kept with the help of a stopwatch.
As soon as the person's foot touches the ground again, the time is stopped.If the person can stand on one leg for 30 seconds, the test is over.
If the time is between 10 seconds and 5 seconds, there is an imbalance.
Even if it is less than 5 seconds, there is a risk of falling.
|
Change from baseline static balance values in 30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue Impact Scale
Time Frame: Change from baseline fatigue scale values in 30 minutes
|
It is used to measure the physical, cognitive and social effects of fatigue.
It consists of a total of 40 questions, of which 10 are cognitive, 10 are physical and 20 are social scales.
Each question scores between 1 and 4. The maximum total score is 160.
Effect of fatigue not at all (0-32) / a little (33-64) / moderate (65-96) / significant (97- 128) / very important (129-160) problem.
In our study, it will be used to evaluate the physical, cognitive and social effects of fatigue resulting from single-leg and double-leg cycling ergometer exercise.
|
Change from baseline fatigue scale values in 30 minutes
|
|
Evaluation of Leg Fatigue with the Modified Borg Scale (MBS)
Time Frame: Change from baseline leg fatigue scale values in 30 minutes
|
This scale was developed by Borg in 1970 to measure the effort expended during physical exercise.
It is a scale that is frequently used to evaluate the severity of dyspnea on exertion and the severity of dyspnea at rest.
It consists of ten items describing the severity of dyspnea according to their degrees.
Defining the severity of dyspnea on the scale makes it easier for patients to apply.
In the studies carried out; It is stated that MBS is a reliable scale for determining the severity of dyspnea at rest and exertion, and is associated with respiratory rate and pulmonary function tests.
In addition, it is emphasized that MBS is superior to other scales in terms of long-term reproducibility and can be used to predict ventilatory reserves of patients.
|
Change from baseline leg fatigue scale values in 30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayşe ARSLANCA, Sağlık Bilimleri Unıversity
- Principal Investigator: Beyza DURAK, Sağlık Bilimleri Unıversity
- Principal Investigator: Serra Nisa KIŞ, Sağlık Bilimleri Unıversity
- Principal Investigator: Sude Asya ALŞAN, Sağlık Bilimleri Unıversity
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Park S, Caldwell GE. Muscular activity patterns in 1-legged vs. 2-legged pedaling. J Sport Health Sci. 2021 Jan;10(1):99-106. doi: 10.1016/j.jshs.2020.01.003. Epub 2020 Jan 20.
- Raez MB, Hussain MS, Mohd-Yasin F. Techniques of EMG signal analysis: detection, processing, classification and applications. Biol Proced Online. 2006;8:11-35. doi: 10.1251/bpo115. Epub 2006 Mar 23. Erratum In: Biol Proced Online. 2006;8:163.
- Ambrosini E, De Marchis C, Pedrocchi A, Ferrigno G, Monticone M, Schmid M, D'Alessio T, Conforto S, Ferrante S. Neuro-Mechanics of Recumbent Leg Cycling in Post-Acute Stroke Patients. Ann Biomed Eng. 2016 Nov;44(11):3238-3251. doi: 10.1007/s10439-016-1660-0. Epub 2016 Jun 1.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 15, 2022
Primary Completion (ANTICIPATED)
December 15, 2022
Study Completion (ANTICIPATED)
September 15, 2023
Study Registration Dates
First Submitted
August 22, 2022
First Submitted That Met QC Criteria
August 22, 2022
First Posted (ACTUAL)
August 24, 2022
Study Record Updates
Last Update Posted (ACTUAL)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 25, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- emgandbalance_cyclingergometer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Exercise, Aerobic
-
Afyonkarahisar Health Sciences UniversityCompleted
-
University of Dublin, Trinity CollegeCompletedAerobic Exercise
-
Holy Name Medical Center, Inc.Not yet recruiting
-
University Hospital MuensterGerman Federal Ministry of Education and ResearchUnknownAerobic Exercise | Anaerobic Exercise | Unchanged ConditionGermany
-
University of MilanUniversita di VeronaRecruitingAerobic Exercise | StretchingItaly
-
Hasan Kalyoncu UniversityNot yet recruiting
-
University of North Carolina, GreensboroRecruitingCognitive Change | Aerobic ExerciseUnited States
-
Ondokuz Mayıs UniversityCompletedExercise Performance | Aerobic CapacityTurkey (Türkiye)
-
Chang Gung Memorial HospitalCompleted
-
Second Affiliated Hospital of Wenzhou Medical UniversityRecruitingAerobic and Resistance ExerciseChina
Clinical Trials on HP Cosmos Torqoalizer
-
Universiti Putra MalaysiaCompletedObesity | Type 2 Diabetes MellitusMalaysia
-
Fundació Institut de Recerca de l'Hospital de la...Programa de Reproducción Asistida F. Puigvert - HSCSPTerminatedPolycystic Ovary SyndromeSpain
-
LG ChemCompletedInfertility, FemaleKorea, Republic of
-
DePuy InternationalCompletedOsteoarthritis | Post-traumatic Arthritis | Gout | Pseudo-goutSwitzerland, Italy
-
HK inno.N CorporationAsan Medical CenterCompleted
-
Hospital de SabadellCorporacion Parc Tauli; Consorcio Centro de Investigación Biomédica en Red...Unknown
-
Purdue UniversitySuspendedAppetite and General Nutritional DisordersUnited States
-
Universidade Federal do ParaCompleted
-
Instituto Valenciano de Infertilidad, IVI VALENCIACompleted
-
Ferring PharmaceuticalsFerring SAUCompleted