NCT02527850

Brief Summary

Low level laser therapy (LLLT) was shown to affect muscle performance and fatigue. The aim of this study is to investigated the effect of B-cure laser on muscle performance and recovery after intense exercise.

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 Aug 2015

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

Study Start

First participant enrolled

August 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

August 18, 2015

Last Update Submit

August 20, 2015

Conditions

Physical Exertion

Outcome Measures

Primary Outcomes (2)

  • improvement in muscle power as indicated in 5 repetitions of flexion/extension of the knee using isokinetic dynamometer before and after laser treatment

    1 hour

  • evaluation of muscle power after induction of muscle fatigue in 5 repetitions of flexion/extension of the knee using isokinetic dynamometer before and after laser treatment

    2 hour

Study Arms (2)

treatment with real laser

EXPERIMENTAL

10 min irradiation with B-cure soft laser on 3 points of quadriceps muscle.

Device: B-cure laser

sham laser

SHAM COMPARATOR

10 min irradiation with sham B-cure soft laser on 3 points of quadriceps muscle.

Device: B-cure laser

Interventions

B-cure laserDEVICE
sham lasertreatment with real laser

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy physical education students, ages 20-35, light or intermediate skin color

You may not qualify if:

  • musculoskeletal injury to hips or knees in the previous 2 months, use pharmacological agents or nutritional supplements regularly, smokers, physical limitations on completing the exercise tests -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wingate Institute

Netanya, Israel

Location

Central Study Contacts

Sharon Tsuk, Ph.D

CONTACT

97298639235sharontsuk2@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 19, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

IL(1)