NCT04367727

Brief Summary

The purpose of this study is to determine the optimal time interval between light emitting diode application and exercise to improve fatigue resistance.The results of this study could be useful in planning a rehabilitation program in musculature disorders and also in athletic training.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

January 24, 2020

Last Update Submit

November 21, 2020

Conditions

Muscle Fatigue

Outcome Measures

Primary Outcomes (4)

  • Isometric peak torque of elbow flexors

    metric unit is Newton

    change from before light emitting diode application at 5 minutes, 1 hour and 5 hours

  • Isometric peak torque of elbow flexors

    metric unit is Newton

    change from before light emitting diode application at1 minute

  • Isokinetic peak torque of elbow flexors

    Metric unit is Newton and at angular velocity 60

    change from before light emitting diode application at 5 minutes, 1 hour and 5 hours

  • Isokinetic peak torque of elbow flexors

    Metric unit is Newton and at angular velocity 60

    change from before light emitting diode application at 1 minute after light emitting diode application

Study Arms (6)

5 minutes before 1

EXPERIMENTAL

Light emitting diode applied 5 minutes before fatiguing task

Device: Light emitting diode

5 minutes before 2

PLACEBO COMPARATOR

Light emitting diode applied 5 minutes before fatiguing task

Device: Light emitting diode

1 hour before 1

EXPERIMENTAL

Light emitting diode applied 1 hour before fatiguing task

Device: Light emitting diode

1 hour before 2

PLACEBO COMPARATOR

Light emitting diode applied 1 hour before fatiguing task

Device: Light emitting diode

5 hours before 1

EXPERIMENTAL

Light emitting diode applied 5 hours before fatiguing task

Device: Light emitting diode

5 hours before 2

PLACEBO COMPARATOR

Light emitting diode applied 5 hours before fatiguing task

Device: Light emitting diode

Interventions

Light emitting diodeDEVICE

Light emitting diode at a wavelength of 890 nm is produced by an array of 60 gallium aluminum arsenide light-emitting diodes located on flexible pads and the near infrared photo energy is delivered in a noninvasive, drug-free manner

1 hour before 11 hour before 25 hours before 15 hours before 25 minutes before 15 minutes before 2

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy non athletics subjects.
  • Age ranges from 20-40 years.
  • Body mass index is less than 25 kg/m 2

You may not qualify if:

  • Neurological deficit and recent injury to either upper extremity
  • non diagnosed pain .
  • Contraindications to LED irradiation (such as light hypersensitivity, fluctuating blood pressure, insufficient blood circulation, fever and inflammation of the skin)
  • Conditions in which physical exertion is contraindicated (such as cardiovascular deficits, hypertension and respiratory problems)
  • Restriction in shoulder or elbow range of motion;
  • Neoplasm,
  • Rheumatoid,
  • Strength training in the past 6 months;
  • Previous surgery in the spine or upper extremity;
  • Complaints of pain in the shoulder, elbow,wrist, and trunk musculature system;
  • Use of dietary supplements; and not in any other exercise program for at least the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 24, 2020

First Posted

April 29, 2020

Study Start

November 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

November 25, 2020

Record last verified: 2020-11

Locations

EG(1)