- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04470362
Effect of Proprioceptive Training on Muscle Fatigue in Older Adults
Beni-Suef University
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study protocol A single blinded randomized parallel study design will be used in this study. 40 participants will be recruited for this study aged from 65 to 90 years old. The randomization will be performed using simple envelop methods. Participants will be divided into two groups, control and study groups. The control group will receive an isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing the quadriceps power and strength.
Participants in the study group will perform the same exercise parameters used in the control group but in a different manner. The isokinetic exercise will be done with a closed eye to improve the proprioception function. This exercise will be performed for 6 sets. We will add another set, in which the participant will be instructed that the range of motion of the knee joint will be divided into three ranges, the outer range (from 0 to 90 degrees of knee flexion), the middle range (90 degrees of flexion) and inner range (from 90 degrees to 145 degree of flexion). During this set, the isokinetic device will be stopped at a different joint angle and the participant will be asked to identify at which range the knee joint is in. This modification is directed to improve the function of muscle spindles and Golgi tendon organs.
Additional training will be performed by the application of three vibrators above and on both sides of the knee joint to improve the function of the Pacinian and Meissner corpuscles which is one of the included receptors in the sensation of the fatigue. This vibration will be set at a subsensory intensity (Stochastic theory39) and a frequency fluctuating frequency from 50 Hz to 250 Hz to train both receptors40 and it will be performed for 20 min/each session. This programs will be performed for three sessions/week for two months.
The primary outcomes measure will be the electromyographical analysis of quadriceps muscle at the onset of muscle fatigue and after recovery. The secondary outcome measures will include the Fatigue Index (FI) and the Rating-of-Fatigue Scale. These measurements at baseline, After one month, After two months.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bani Suwayf
-
Banī Suwayf, Bani Suwayf, Egypt, 43561
- Beni Suef University
-
Contact:
- Ibrahim Ragab
- Phone Number: 01003068518
- Email: Ibrahim.Ragab982@gmail.com
-
Contact:
- Ayman
- Phone Number: 0100306818
- Email: dr_ayman_pt@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elderlies over 65 years old
Exclusion Criteria:
- No previous history of lower extremity trauma, serious metabolic, neurological, muscular, inflammatory or cardiovascular diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control group
The control group will receive an isokinetic strengthening program for the quadriceps muscles.
Twenty-four strengthening session will be performed using an isokinetic device.
The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback.
An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance.
Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors.
This program accomplished significant results in increasing quadriceps power and strength.
|
an isokinetic strengthening program for the quadriceps muscles.
Twenty-four strengthening session will be performed using an isokinetic device.
The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback.
An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance.
Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors.
This program accomplished significant results in increasing the quadriceps power and strength.
|
Experimental: Study group
|
an isokinetic strengthening program for the quadriceps muscles.
Twenty-four strengthening session will be performed using an isokinetic device.
The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback.
An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance.
Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors.
This program accomplished significant results in increasing the quadriceps power and strength.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EMG of quadriceps muscles
Time Frame: Two Months
|
The electromyographical analysis of quadriceps muscle at the onset of muscle fatigue and after recovery
|
Two Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The fatigue index (FI)
Time Frame: Two months
|
The fatigue index (FI) was calculated according to the following formula (Bar-Or, 1987): FI = (maximal pedal speed - minimal pedal speed) / maximal pedal speed * 100.
|
Two months
|
Rating-of-Fatigue Scale
Time Frame: Two months
|
he ROF scale consists of 11 numerical points that range from 0 to 10. There are also five descriptors and five diagrams to help the person understand the scale and make a rating. The Rating of fatigue scale consists of 11 numerical points that range from 0 to 10. There are also five descriptors and five diagrams to help the person understand the scale and make a rating. |
Two months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 250982
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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 Proprioceptive Disorders
-
KU LeuvenUniversitaire Ziekenhuizen KU LeuvenCompletedProprioceptive Postural ControlBelgium
-
Istanbul Aydın UniversityPamukkale UniversityActive, not recruitingHemiparesis Proprioceptive Disorders Gait, Hemiplegic, Healthy Individual, Comparative StudyTurkey
-
University Hospital, CaenCompletedProprioceptive DisordersFrance
-
Dokuz Eylul UniversityCompletedProprioceptive DisordersTurkey
-
Investigación en Hemofilia y FisioterapiaCompletedProprioceptive DisordersSpain
-
Investigación en Hemofilia y FisioterapiaCompletedProprioceptive DisordersSpain
-
Investigación en Hemofilia y FisioterapiaWithdrawnProprioceptive DisordersSpain
-
Investigación en Hemofilia y FisioterapiaCompletedProprioceptive DisordersSpain
-
Istituto Ortopedico RizzoliUniversity of BolognaCompleted
-
University of JazanCompletedMotor Activity | Proprioceptive Disorders | Balance; DistortedSaudi Arabia
Clinical Trials on Isokinetic dynamometer
-
University of BrasiliaCompleted
-
National Yang Ming UniversityFu Jen Catholic UniversityCompleted
-
University of Sao Paulo General HospitalCompletedSevere ObesityBrazil
-
São Paulo State UniversityCoordination for the Improvement of Higher Education PersonnelCompleted
-
São Paulo State UniversityCompletedMuscle Strength Quantitative Trait Locus 1Brazil
-
University Hospital, CaenInstitut National de la Santé Et de la Recherche Médicale, FranceUnknownACL Tear | ACL - Anterior Cruciate Ligament DeficiencyFrance
-
University of SharjahNot yet recruiting
-
Prof. Dr. Cemil Tascıoglu Education and Research...CompletedQuality of Life | Home ExerciseTurkey
-
University of Kansas Medical CenterKurume UniversityCompleted