The Effect of Bicycle Ergometer Training on Balance and Emg Activity

NCT05514392 | Unknown

• 1 other identifier: emgandbalance_cyclingergometer
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise, Aerobic

Keywords

electromyography; balance; muscle fatigue; single leg cycling training

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Fatigue Impact Scale

  Change from baseline fatigue scale values in 30 minutes

• Evaluation of Leg Fatigue with the Modified Borg Scale (MBS)

  Change from baseline leg fatigue scale values in 30 minutes

Study Arms (2)

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.

Device: HP Cosmos Torqoalizer

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.

Device: HP Cosmos Torqoalizer

Interventions

HP Cosmos Torqoalizer DEVICE

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; Receiving Single Leg Cycling Ergometer Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 33518019 BACKGROUND

• 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.

  PMID: 16799694 BACKGROUND

• 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.

  PMID: 27251336 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ayşe ARSLANCA

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Beyza DURAK

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Serra Nisa KIŞ

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Sude Asya ALŞAN

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra PEHLİVAN

CONTACT

0216 346 36 36; esra.pehlivan@sbu.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: September 15, 2022
• Primary Completion: December 15, 2022
• Study Completion: September 15, 2023
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

TU (1)