NCT03287284

Brief Summary

Phototherapy has been largely used in rehabilitation programs due to its analgesic, antiinflammatory and healing effects. Lately, its effects of optimizing the results of resistance training on young individuals have been studied. However, there is a lack of studies on its effect on the elderly population. The objective of the present study is to verify the effect of Low-Level Laser Therapy (LLLT) on the results of resistance training in the elderly. The study will be a randomized doubled-blinded controlled trial. 30 elderly men with age ranging from 60 to 80 years will be included and randomized between Placebo Group (placebo LLLT + Resistance Training) and LLLT Group (active LLLT + Resistance Training). All volunteers will be submitted to a control period of four weeks before the beginning of the resistance training, which will have 12 weeks of duration. The assessments will be done at baseline, after the control period and after the training period. The training sessions will be performed twice a week and the training protocol will be performed with repetition maximum periodization. The LLLT will be applied before the training sessions on eight points of the quadriceps muscles, leading to a total of 240 Joules on each leg. The placebo LLLT will be applied on the same way, but with the equipment turned off. The assessments will include muscle architecture by ultrasonography, muscle strength by isokinetic dynamometer and 1 Repetition Maximum test of leg-extension and leg-press exercises, and functional capacity by the 6-Minute Walking Test, 30s Sit to Stand Test, Timed Up-and-Go Test and Stair Ascent Test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 6, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2017

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

10 months

First QC Date

September 15, 2017

Last Update Submit

July 31, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Isokinetic peak torque of quadriceps muscle

    Change from baseline in isokinetic peak torque at 12 weeks

Secondary Outcomes (4)

  • Leg-extension 1RM test

    Change from baseline in leg-extension 1RM test at 12 weeks

  • Leg-press 1RM test

    Change from baseline in leg-press 1RM test at 12 weeks

  • Muscle architecture

    Change from baseline in muscle architecture at 12 weeks

  • Physical Function

    Change from baseline in physical function at 12 weeks

Study Arms (2)

LLLT Group

ACTIVE COMPARATOR

Active Low Level Laser Therapy application with a dose of 240 Joules before resistance training

Device: Active Low Level Laser TherapyBehavioral: Resistance Training

Placebo Group

PLACEBO COMPARATOR

Placebo Low Level Laser Therapy application before resistance training

Behavioral: Resistance TrainingDevice: Placebo Low Level Laser Therapy

Interventions

Active application of Low Level Laser Therapy with a dose of 240 Joules

LLLT Group

Resistance Training

LLLT GroupPlacebo Group

Placebo application of Low Level Laser Therapy

Placebo Group

Eligibility Criteria

Age60 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly men with age ranging from 60 to 80 years in condition to participate in the strength training program.

You may not qualify if:

  • Individuals who already participate in strength training programs;
  • Individuals who participated in strength training programs less than three months before the beginning of the study;
  • Individuals with any kind musculoskeletal injuries in the lower limbs that impair the performance of the exercises;
  • Individuals with contraindications to the performance of high intensity exercises, such as cardiovascular or neurological diseases;
  • Individuals with difficulties in understanding and/or performing the exercises;
  • Individuals who did not attend to at least 85% of the sessions or had 02 consecutive absences and did not recover them.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Pôrto Alegre, Brazil

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

September 15, 2017

First Posted

September 19, 2017

Study Start

March 6, 2017

Primary Completion

December 22, 2017

Study Completion

December 22, 2017

Last Updated

August 1, 2018

Record last verified: 2018-07

Locations