NCT04470362

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

Same day

First QC Date

July 10, 2020

Last Update Submit

July 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • EMG of quadriceps muscles

    The electromyographical analysis of quadriceps muscle at the onset of muscle fatigue and after recovery

    Two Months

Secondary Outcomes (2)

  • The fatigue index (FI)

    Two months

  • Rating-of-Fatigue Scale

    Two months

Study Arms (2)

Control group

PLACEBO COMPARATOR

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.

Device: Isokinetic dynamometer

Study group

EXPERIMENTAL

* 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.

Device: Isokinetic dynamometer

Interventions

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.

Control groupStudy group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderlies over 65 years old

You may not qualify if:

  • No previous history of lower extremity trauma, serious metabolic, neurological, muscular, inflammatory or cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni Suef University

Banī Suwayf, Beni Suweif Governorate, 43561, Egypt

Location

MeSH Terms

Conditions

Somatosensory Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Beni-Suef University

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 14, 2020

Study Start

April 1, 2021

Primary Completion

April 1, 2021

Study Completion

September 1, 2021

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations