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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05514392
Other study ID # emgandbalance_cyclingergometer
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 15, 2022
Est. completion date September 15, 2023

Study information

Verified date August 2022
Source Saglik Bilimleri Universitesi
Contact Esra PEHLIVAN
Phone 0216 346 36 36
Email esra.pehlivan@sbu.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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 360ĚŠ 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date September 15, 2023
Est. primary completion date December 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
HP Cosmos Torqoalizer
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.

Locations

Country Name City State
Turkey Saglik Bilimleri Üniversitesi Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

Raez MB, Hussain MS, Mohd-Yasin F. Techniques of EMG signal analysis: detection, processing, classification and applications. Biol Proced Online. 2006;8:11-35. Epub 2006 Mar 23. Erratum in: Biol Proced Online. 2006;8:163. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Superficial Electromyographic (EMG) Measurement 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
Primary Static-Dynamic Balance Evaluation with Isokinetic Balance Device 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
Primary Static Balance Evaluation with One Leg Standing Balance Test 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 Fatigue Impact Scale 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
Secondary Evaluation of Leg Fatigue with the Modified Borg Scale (MBS) 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
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