Elderly MenNCT03287284
Phototherapy in Association to Resistance Training in the Elderly: the Effect on Muscle Strength, Muscle Mass and Functional Capacity
A study testing Active Low Level Laser Therapy and Resistance Training in people with Elderly Men, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Elderly Men
- What is being tested?
- Active Low Level Laser Therapy and Resistance Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Mar 2017to 22 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elderly men with age ranging from 60 to 80 years in condition to participate in the strength training program.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Elderly Men
- Being tested
- Active Low Level Laser Therapy, Resistance Training, Placebo Low Level Laser Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Low Level Laser TherapyDevice
Active application of Low Level Laser Therapy with a dose of 240 Joules
Resistance TrainingBehavioural
Resistance Training
Placebo Low Level Laser TherapyDevice
Placebo application of Low Level Laser Therapy
| Study group | Role | What they receive |
|---|---|---|
| LLLT Group | Active comparator | Active Low Level Laser Therapy application with a dose of 240 Joules before resistance training Receives: Device: Active Low Level Laser Therapy; Behavioral: Resistance Training |
| Placebo Group | Placebo comparator | Placebo Low Level Laser Therapy application before resistance training Receives: Behavioral: Resistance Training; Device: Placebo Low Level Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic peak torque of quadriceps muscle
Measured: Change from baseline in isokinetic peak torque at 12 weeks
Secondary outcomes (4)
Leg-extension 1RM test
Measured: Change from baseline in leg-extension 1RM test at 12 weeks
Leg-press 1RM test
Measured: Change from baseline in leg-press 1RM test at 12 weeks
Muscle architecture
Measured: Change from baseline in muscle architecture at 12 weeks
Physical Function
Measured: Change from baseline in physical function at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start6 Mar 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Manfredini Baroni, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287284
- Sponsor's protocol ID
- 59328316.9.0000.5345
- Status last verified
- Jul 2018
- First submitted
- 15 Sep 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phototherapy in Association to Resistance Training in the Elderly: the Effect on Muscle Strength, Muscle Mass and Functional Capacity
- ClinicalTrials.gov ID
- NCT03287284
- Acronym / sponsor ID
- 59328316.9.0000.5345
- Conditions
- Elderly Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LLLT Group | Active comparator | Device: Active Low Level Laser Therapy, Behavioral: Resistance TrainingActive Low Level Laser Therapy application with a dose of 240 Joules before resistance training |
| Placebo Group | Placebo comparator | Behavioral: Resistance Training, Device: Placebo Low Level Laser TherapyPlacebo Low Level Laser Therapy application before resistance training |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elderly men with age ranging from 60 to 80 years in condition to participate in the strength training program.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Low Level Laser TherapyActive application of Low Level Laser Therapy with a dose of 240 Joules | Device | LLLT Group |
| Resistance TrainingResistance Training | Behavioural | LLLT Group, Placebo Group |
| Placebo Low Level Laser TherapyPlacebo application of Low Level Laser Therapy | Device | Placebo Group |
Primary outcome
Isokinetic peak torque of quadriceps muscle
Time frame: Change from baseline in isokinetic peak torque at 12 weeks
4 secondary outcomes
Leg-extension 1RM test
Time frame: Change from baseline in leg-extension 1RM test at 12 weeks
Leg-press 1RM test
Time frame: Change from baseline in leg-press 1RM test at 12 weeks
Muscle architecture
Time frame: Change from baseline in muscle architecture at 12 weeks
Physical Function
Time frame: Change from baseline in physical function at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Low Level Laser Therapy and Resistance Training in people with Elderly Men, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic peak torque of quadriceps muscle (time frame: Change from baseline in isokinetic peak torque at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.