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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03287284
Other study ID # 59328316.9.0000.5345
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2017
Est. completion date December 22, 2017

Study information

Verified date July 2018
Source Federal University of Health Science of Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 22, 2017
Est. primary completion date December 22, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Active Low Level Laser Therapy
Active application of Low Level Laser Therapy with a dose of 240 Joules
Behavioral:
Resistance Training
Resistance Training
Device:
Placebo Low Level Laser Therapy
Placebo application of Low Level Laser Therapy

Locations

Country Name City State
Brazil Universidade Federal do Rio Grande do Sul Pôrto Alegre

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Isokinetic peak torque of quadriceps muscle Change from baseline in isokinetic peak torque at 12 weeks
Secondary Leg-extension 1RM test Change from baseline in leg-extension 1RM test at 12 weeks
Secondary Leg-press 1RM test Change from baseline in leg-press 1RM test at 12 weeks
Secondary Muscle architecture Change from baseline in muscle architecture at 12 weeks
Secondary Physical Function Change from baseline in physical function at 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT02095080 - Determination of the UL of Leucine in Healthy Elderly Men N/A