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Phototherapy in Association to Resistance Training in the Elderly: the Effect on Muscle Strength, Muscle Mass and Functional Capacity

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ClinicalTrials.gov Identifier: NCT03287284
Recruitment Status : Completed
First Posted : September 19, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Bruno Manfredini Baroni, Federal University of Health Science of Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Elderly Men Device: Active Low Level Laser Therapy Behavioral: Resistance Training Device: Placebo Low Level Laser Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phototherapy in Association to Resistance Training in the Elderly: the Effect on Muscle Strength, Muscle Mass and Functional Capacity
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Arm Intervention/treatment
Active Comparator: LLLT Group
Active Low Level Laser Therapy application with a dose of 240 Joules before resistance training
Device: Active Low Level Laser Therapy
Active application of Low Level Laser Therapy with a dose of 240 Joules

Behavioral: Resistance Training
Resistance Training

Placebo Comparator: Placebo Group
Placebo Low Level Laser Therapy application before resistance training
Behavioral: Resistance Training
Resistance Training

Device: Placebo Low Level Laser Therapy
Placebo application of Low Level Laser Therapy




Primary Outcome Measures :
  1. Isokinetic peak torque of quadriceps muscle [ Time Frame: Change from baseline in isokinetic peak torque at 12 weeks ]

Secondary Outcome Measures :
  1. Leg-extension 1RM test [ Time Frame: Change from baseline in leg-extension 1RM test at 12 weeks ]
  2. Leg-press 1RM test [ Time Frame: Change from baseline in leg-press 1RM test at 12 weeks ]
  3. Muscle architecture [ Time Frame: Change from baseline in muscle architecture at 12 weeks ]
  4. Physical Function [ Time Frame: Change from baseline in physical function at 12 weeks ]


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287284


Locations
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Brazil
Universidade Federal do Rio Grande do Sul
Pôrto Alegre, Brazil
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre

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Responsible Party: Bruno Manfredini Baroni, Phd, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT03287284     History of Changes
Other Study ID Numbers: 59328316.9.0000.5345
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes