Effect of Proprioceptive Training on Muscle Fatigue in Older Adults

July 10, 2020 updated by: Ayman Mohamed

Beni-Suef University

Summary Muscle fatigue is a serious problem commonly occur in older ages. Muscle fatigue disturbs both daily life activities and rehabilitation tolerance in elderlies. Muscle fatigue happens due to the motor or sensory dysfunctions. The previous interventions focused mainly on the motor causes of muscle fatigue, however the important role of the sensory system in driving the motor system. It has been demonstrated that proprioceptors are mainly responsible for sensing the muscle fatigue. Objectives: This study will be conducted to investigate 1. The effect of proprioception training on reducing the occurrence of muscle fatigue in elderlies. 2. The effect of proprioceptive training on delaying the deterioration in electromyographical data from muscles of lower limbs.

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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

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

63 years to 88 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

  • 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
  • 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.
  • 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.
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

This is where you will find people and organizations involved with this study.

Sponsor

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)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 250982

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

product manufactured in and exported from the U.S.

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.

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