AgingNCT02516189
Strength Training for Elderlies and Their Effects on Muscle Fatigue and Microcirculation - Randomized Clinical Trial
A study testing Strength training program in people with Aging, run by Professor Fernando Figueira Integral Medicine Institute.
Trial summary
The purpose of this study is to verify the effects of a strength training program on functional capacity, muscle performance and microcirculation in the elderly. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Strength training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2016
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- sedentary elderly
- individuals who have physical and medical conditions to perform strength training
- individuals who participate in the Open University Maturity Program
Who cannot join
- individuals who do not have physical and medical conditions to perform strength training
About this study
The purpose of this study is to verify the effects of a strength training program on functional capacity, muscle performance and microcirculation in the elderly.
Read the detailed description
Purpose
The primary research question is:
Do muscular strength training programs can improve functional capacity, muscle performance and microcirculation in the elderly? Hypothesis: Strength training program will promote electromyographic changes during the development of peripheral muscle fatigue and microcirculatory blood flow contributing to functional autonomy.
Secondary Research Questions
- Does the strength training program in the elderly improve the standard of electromyographic fatigue? Hypothesis: Elderly practitioners of strength exercise program showed increased neuromuscular efficiency and electromyographic fatigue index.
- Do the strength training program in the elderly improve peripheral microcirculation? Hypothesis: A regular program of strength exercise in the elderly increases the blood flow in peripheral microcirculation changing the process of muscle fatigue. These biomechanical and physiological changes contribute to increased functional autonomy and reducing the risk of falls in the elderly.
- Conditions
- Aging
- Being tested
- Strength training program
- Keywords
- Microcirculation, Electromyography, Motor Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength training programOther
Strength Training program applied twice a week for sixteen weeks. Each training exercises has a total time of 50 minutes. Warm-up: 5 minutes of stretching. Training: Leg press; Leg Curl; Vertical traction; Chest press; Abdominal crunch; Lower back. Gametherapy.
Relaxation: 5 minutes of stretching.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | group of elderly participants of strength training program Receives: Other: Strength training program |
| Group B | No intervention | group of seniors who did not practice strength training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in elderlies's microcirculatory blood flow after 4 months
The blood flow in the microcirculation in the elderly will be measured by laser-doppler flowmetry. The measures blood flow in the microcirculation will be quantified by the reactive hyperemia Post-occlusion protocol (PORH).
Measured: 4 months
Change in elderlies's muscle fatigue after 4 months
muscle fatigue will be quantified by surface electromyography of the muscles of the lower limbs. The electromyographic fatigue threshold and fatigue index will be calculated by the Root Mean Square (RMS) and Median Frequency variables after 4 months.
Measured: 4 months
Change in elderlies's functional capacity after 4 months
The functional capacity of the elderly will be evaluated by the Berg Balance Scale, the Timed up-and-go Test, and Falls Efficacy Scale International (FES-I) after 4 months
Measured: 4 months
Secondary outcomes (2)
Change in elderlies's strength after 4 months
The lower body strength of the elderly will be measured by 30-s chair test stand after 4 months.
Measured: 4 months
Change in elderlies's functional autonomy after 4 months
The functional autonomy of the elderly will be determined by the general functionality index of the Latin American Development Group to Maturity Protocol after 4 months.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual da Paraiba
- Responsible party
- Principal investigator, João Guilherme Bezerra Alves, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- Danilo A Vasconcelos, MS, Principal investigator, Universidade Estadual da ParaibaJoão G Alves, PhD, Principal investigator, Instituto de Medicina Integral Professor Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516189
- Sponsor's protocol ID
- FEFMM
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2015
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training for Elderlies and Their Effects on Muscle Fatigue and Microcirculation - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02516189
- Acronym / sponsor ID
- FEFMM
- Conditions
- Aging
- Keywords
- Microcirculation, Electromyography, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Collaborators
- Universidade Estadual da Paraiba
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Aug 2015 (estimated)
- 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.
The purpose of this study is to verify the effects of a strength training program on functional capacity, muscle performance and microcirculation in the elderly.
Detailed description
Purpose
The primary research question is:
Do muscular strength training programs can improve functional capacity, muscle performance and microcirculation in the elderly? Hypothesis: Strength training program will promote electromyographic changes during the development of peripheral muscle fatigue and microcirculatory blood flow contributing to functional autonomy.
Secondary Research Questions
- Does the strength training program in the elderly improve the standard of electromyographic fatigue? Hypothesis: Elderly practitioners of strength exercise program showed increased neuromuscular efficiency and electromyographic fatigue index.
- Do the strength training program in the elderly improve peripheral microcirculation? Hypothesis: A regular program of strength exercise in the elderly increases the blood flow in peripheral microcirculation changing the process of muscle fatigue. These biomechanical and physiological changes contribute to increased functional autonomy and reducing the risk of falls in the elderly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Strength training programgroup of elderly participants of strength training program |
| Group B | No intervention | –group of seniors who did not practice strength training program |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- sedentary elderly
- individuals who have physical and medical conditions to perform strength training
- individuals who participate in the Open University Maturity Program
Key exclusion criteria (1 listed)
- individuals who do not have physical and medical conditions to perform strength training
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 |
|---|---|---|
| Strength training programStrength Training program applied twice a week for sixteen weeks. Each training exercises has a total time of 50 minutes. Warm-up: 5 minutes of stretching. Training: Leg press; Leg Curl; Vertical traction; Chest press; Abdominal crunch; Lower back. Gametherapy. Relaxation: 5 minutes of stretching. | Other | Group A |
Primary outcome
Change in elderlies's microcirculatory blood flow after 4 months
Time frame: 4 months
The blood flow in the microcirculation in the elderly will be measured by laser-doppler flowmetry. The measures blood flow in the microcirculation will be quantified by the reactive hyperemia Post-occlusion protocol (PORH).
Change in elderlies's muscle fatigue after 4 months
Time frame: 4 months
muscle fatigue will be quantified by surface electromyography of the muscles of the lower limbs. The electromyographic fatigue threshold and fatigue index will be calculated by the Root Mean Square (RMS) and Median Frequency variables after 4 months.
Change in elderlies's functional capacity after 4 months
Time frame: 4 months
The functional capacity of the elderly will be evaluated by the Berg Balance Scale, the Timed up-and-go Test, and Falls Efficacy Scale International (FES-I) after 4 months
2 secondary outcomes
Change in elderlies's strength after 4 months
Time frame: 4 months
Change in elderlies's functional autonomy after 4 months
Time frame: 4 months
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 15 Aug 2016.
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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.
Danilo A Vasconcelos, MS principal investigator
Universidade Estadual da Paraiba
João G Alves, PhD principal investigator
Instituto de Medicina Integral Professor Fernando Figueira
Questions about this trial
What is this clinical trial studying?
A study testing Strength training program in people with Aging, run by Professor Fernando Figueira Integral Medicine Institute.
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 3 inclusion and 1 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 15 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Change in elderlies's microcirculatory blood flow after 4 months (time frame: 4 months). The study lists 3 primary outcomes in all. 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 15 Aug 2016.