AgingNCT03619070
Fatigability and Physical Performance: Effects of Resistance Training Variables Manipulation
A study testing Resistance training, LL, Resistance training, HL and Resistance training, HVHL in people with Aging, run by Universidade Federal do Triangulo Mineiro at 1 site in Brazil.
Trial summary
This study evaluate whether resistance training variables modulate the fatigability (power-duration relationship) and physical performance in adults and older adults Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Resistance training, LL, Resistance training, HL and Resistance training, HVHL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 20 May 2018to 15 Nov 2018
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women (>12 months amenorrhea) with age above or equal 50 years old.
- No hormone therapy or phytoestrogens
Who cannot join
- No-drinker alcohol (no alcohol intake whatsoever in their diet);
- Non- smokers;
- Hypertensive with uncontrolled blood pressure values;
- Diabetic with uncontrolled glycemia;
- Presence of arthropathies;
- Presence of myopathies;
- Skeletal musculotendinous disorder.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Post-degree program in physical education
Uberaba, MG - Minas Gerais, 38061-500
Fabio L Orsatti, +55 34 3700-6634, fabiorsatti@gmail.com
About this study
This study evaluate whether resistance training variables modulate the fatigability (power-duration relationship) and physical performance in adults and older adults
Read the detailed description
The resistance training variables manipulation is utilized for maximize the results of resistance training. However it is unclear whether the resistance training variables manipulation modulates the fatigability (i.e. power-duration relationship) and whether this explains the improvement on physical performance (i.e. gait speed, sit-to-stand and timed up and go tests).
- Conditions
- Aging
- Being tested
- Resistance training, LL, Resistance training, HL, Resistance training, HVHL, Control group, CG
- Keywords
- Fatigability, Postmenopausal Woman, Resistance training, Physical performance, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training, LLOther
In LL, the postmenopausal women will be submitted to 12 weeks of Resistance training with moderate volume (i.e. three sets per exercise) and low load (i.e. 30% of one repetition maximum)
Resistance training, HLOther
In HL, the postmenopausal women will be submitted to 12 weeks of Resistance training with moderate volume (i.e. three sets per exercise) and high load (i.e. 80% of one repetition maximum)
Resistance training, HVHLOther
In HVHL, the postmenopausal women will be submitted to 12 weeks of Resistance training with high volume (i.e. six sets per exercise) and hig load (i.e. 80% of one maximum repetition)
Control group, CGOther
The CG groups do not will performed the exercise.
| Study group | Role | What they receive |
|---|---|---|
| Lower load resistance training (LL) | Experimental | In the LL group, postmenopausal women will perform the resistance training with moderate volume (i.e. three sets per exercise performed until or close to failure) and low load (i.e. 30% of 1RM) Receives: Other: Resistance training, LL |
| Higher load resistance training (HL) | Experimental | In the HL group, postmenopausal women will perform the resistance training with moderate volume (i.e. three sets per exercise performed until or close to failure) and high load (i.e. 80% of 1RM) Receives: Other: Resistance training, HL |
| Higher volume resistance training (HVHL) | Experimental | In the HVHL group, postmenopausal women will perform the resistance training with high volume (i.e. six sets per exercise performed until or close to failure) and high load (i.e. 80% of 1RM) Receives: Other: Resistance training, HVHL |
| Control group, (CG) | Other | In CG, the postmenopausal women group will not perform exercise Receives: Other: Control group, CG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigability
The fatigability will be evaluate by 60 maximum voluntary isometric contractions (3 s contraction, 2 s rest) in knee extensors at 70 degree.
Measured: Changes in fatigability measure (e.g. baseline and after 12 weeks of intervention)
Secondary outcomes (1)
Physical Performance
The physical performance will be evaluate by gait speed tests (e.g. 10m walking at usual and fast pace, 400m walk at usual and fast pace).
Measured: Changes in physical performance measure (e.g. baseline and after 12 weeks of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start20 May 2018
- Primary completion30 Sep 2018 (estimated)
- Study completion15 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Triangulo Mineiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fábio Lera Orsatti, Universidade Federal do Triangulo Mineiro
- Investigators
- Fabio L Orsatti, PhD, Principal investigator, Federal University of Triangulo Mineiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619070
- Sponsor's protocol ID
- 85052218.0.0000.5154
- Status last verified
- Aug 2018
- First submitted
- 1 Aug 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aagaard P, Simonsen EB, Andersen JL, Magnusson P, Dyhre-Poulsen P. Increased rate of force development and neural drive of human skeletal muscle following resistance training. J Appl Physiol (1985). 2002 Oct;93(4):1318-26. doi: 10.1152/japplphysiol.00283.2002.
PubMed 12235031American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
PubMed 19204579Asikainen TM, Kukkonen-Harjula K, Miilunpalo S. Exercise for health for early postmenopausal women: a systematic review of randomised controlled trials. Sports Med. 2004;34(11):753-78. doi: 10.2165/00007256-200434110-00004.
PubMed 15456348Benini R, Prado Nunes PR, Orsatti CL, Barcelos LC, Orsatti FL. Effects of acute total body resistance exercise on hormonal and cytokines changes in men and women. J Sports Med Phys Fitness. 2015 Apr;55(4):337-44.
PubMed 25853878Burnley M. Estimation of critical torque using intermittent isometric maximal voluntary contractions of the quadriceps in humans. J Appl Physiol (1985). 2009 Mar;106(3):975-83. doi: 10.1152/japplphysiol.91474.2008. Epub 2009 Jan 15.
PubMed 19150854Ferrucci L, Penninx BW, Volpato S, Harris TB, Bandeen-Roche K, Balfour J, Leveille SG, Fried LP, Md JM. Change in muscle strength explains accelerated decline of physical function in older women with high interleukin-6 serum levels. J Am Geriatr Soc. 2002 Dec;50(12):1947-54. doi: 10.1046/j.1532-5415.2002.50605.x.
PubMed 12473005Fink J, Kikuchi N, Yoshida S, Terada K, Nakazato K. Impact of high versus low fixed loads and non-linear training loads on muscle hypertrophy, strength and force development. Springerplus. 2016 May 20;5(1):698. doi: 10.1186/s40064-016-2333-z. eCollection 2016.
PubMed 27350928Gurjao AL, Gobbi LT, Carneiro NH, Goncalves R, Ferreira de Moura R, Cyrino ES, Altimari LR, Gobbi S. Effect of strength training on rate of force development in older women. Res Q Exerc Sport. 2012 Jun;83(2):268-75. doi: 10.1080/02701367.2012.10599857.
PubMed 22808712Klass M, Baudry S, Duchateau J. Voluntary activation during maximal contraction with advancing age: a brief review. Eur J Appl Physiol. 2007 Jul;100(5):543-51. doi: 10.1007/s00421-006-0205-x. Epub 2006 Jun 9.
PubMed 16763836Lera Orsatti F, Nahas EA, Maesta N, Nahas Neto J, Lera Orsatti C, Vannucchi Portari G, Burini RC. Effects of resistance training frequency on body composition and metabolics and inflammatory markers in overweight postmenopausal women. J Sports Med Phys Fitness. 2014 Jun;54(3):317-25.
PubMed 24739294Maffiuletti NA, Aagaard P, Blazevich AJ, Folland J, Tillin N, Duchateau J. Rate of force development: physiological and methodological considerations. Eur J Appl Physiol. 2016 Jun;116(6):1091-116. doi: 10.1007/s00421-016-3346-6. Epub 2016 Mar 3.
PubMed 26941023Marsh AP, Miller ME, Saikin AM, Rejeski WJ, Hu N, Lauretani F, Bandinelli S, Guralnik JM, Ferrucci L. Lower extremity strength and power are associated with 400-meter walk time in older adults: The InCHIANTI study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1186-93. doi: 10.1093/gerona/61.11.1186.
PubMed 17167161Masson CR, Dias-da-Costa JS, Olinto MT, Meneghel S, Costa CC, Bairros F, Hallal PC. [Prevalence of physical inactivity in adult women in Sao Leopoldo, Rio Grande do Sul, Brazil]. Cad Saude Publica. 2005 Nov-Dec;21(6):1685-95. doi: 10.1590/s0102-311x2005000600015. Epub 2006 Jan 9. Portuguese.
PubMed 16410852Muscaritoli M, Anker SD, Argiles J, Aversa Z, Bauer JM, Biolo G, Boirie Y, Bosaeus I, Cederholm T, Costelli P, Fearon KC, Laviano A, Maggio M, Rossi Fanelli F, Schneider SM, Schols A, Sieber CC. Consensus definition of sarcopenia, cachexia and pre-cachexia: joint document elaborated by Special Interest Groups (SIG) "cachexia-anorexia in chronic wasting diseases" and "nutrition in geriatrics". Clin Nutr. 2010 Apr;29(2):154-9. doi: 10.1016/j.clnu.2009.12.004. Epub 2010 Jan 8.
PubMed 20060626Nunes PR, Barcelos LC, Oliveira AA, Furlanetto Junior R, Martins FM, Orsatti CL, Resende EA, Orsatti FL. Effect of resistance training on muscular strength and indicators of abdominal adiposity, metabolic risk, and inflammation in postmenopausal women: controlled and randomized clinical trial of efficacy of training volume. Age (Dordr). 2016 Apr;38(2):40. doi: 10.1007/s11357-016-9901-6. Epub 2016 Mar 17.
PubMed 26984105
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigability and Physical Performance: Effects of Resistance Training Variables Manipulation
- ClinicalTrials.gov ID
- NCT03619070
- Acronym / sponsor ID
- 85052218.0.0000.5154
- Conditions
- Aging
- Keywords
- Fatigability, Postmenopausal Woman, Resistance training, Physical performance, Older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade Federal do Triangulo MineiroUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 15 Nov 2018 (estimated)
- First posted
- 7 Aug 2018 (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.
This study evaluate whether resistance training variables modulate the fatigability (power-duration relationship) and physical performance in adults and older adults
Detailed description
The resistance training variables manipulation is utilized for maximize the results of resistance training. However it is unclear whether the resistance training variables manipulation modulates the fatigability (i.e. power-duration relationship) and whether this explains the improvement on physical performance (i.e. gait speed, sit-to-stand and timed up and go tests).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lower load resistance training (LL) | Experimental | Other: Resistance training, LLIn the LL group, postmenopausal women will perform the resistance training with moderate volume (i.e. three sets per exercise performed until or close to failure) and low load (i.e. 30% of 1RM) |
| Higher load resistance training (HL) | Experimental | Other: Resistance training, HLIn the HL group, postmenopausal women will perform the resistance training with moderate volume (i.e. three sets per exercise performed until or close to failure) and high load (i.e. 80% of 1RM) |
| Higher volume resistance training (HVHL) | Experimental | Other: Resistance training, HVHLIn the HVHL group, postmenopausal women will perform the resistance training with high volume (i.e. six sets per exercise performed until or close to failure) and high load (i.e. 80% of 1RM) |
| Control group, (CG) | Other | Other: Control group, CGIn CG, the postmenopausal women group will not perform exercise |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women (>12 months amenorrhea) with age above or equal 50 years old.
- No hormone therapy or phytoestrogens
Key exclusion criteria (7 listed)
- No-drinker alcohol (no alcohol intake whatsoever in their diet);
- Non- smokers;
- Hypertensive with uncontrolled blood pressure values;
- Diabetic with uncontrolled glycemia;
- Presence of arthropathies;
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 |
|---|---|---|
| Resistance training, LLIn LL, the postmenopausal women will be submitted to 12 weeks of Resistance training with moderate volume (i.e. three sets per exercise) and low load (i.e. 30% of one repetition maximum) | Other | Lower load resistance training (LL) |
| Resistance training, HLIn HL, the postmenopausal women will be submitted to 12 weeks of Resistance training with moderate volume (i.e. three sets per exercise) and high load (i.e. 80% of one repetition maximum) | Other | Higher load resistance training (HL) |
| Resistance training, HVHLIn HVHL, the postmenopausal women will be submitted to 12 weeks of Resistance training with high volume (i.e. six sets per exercise) and hig load (i.e. 80% of one maximum repetition) | Other | Higher volume resistance training (HVHL) |
| Control group, CGThe CG groups do not will performed the exercise. | Other | Control group, (CG) |
Primary outcome
Fatigability
Time frame: Changes in fatigability measure (e.g. baseline and after 12 weeks of intervention)
The fatigability will be evaluate by 60 maximum voluntary isometric contractions (3 s contraction, 2 s rest) in knee extensors at 70 degree.
1 secondary outcome
Physical Performance
Time frame: Changes in physical performance measure (e.g. baseline and after 12 weeks of intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Background: PubMed 12235031Aagaard P, Simonsen EB, Andersen JL, Magnusson P, Dyhre-Poulsen P. Increased rate of force development and neural drive of human skeletal muscle following resistance training. J Appl Physiol (1985). 2002 Oct;93(4):1318-26. doi: 10.1152/japplphysiol.00283.2002.
- Background: PubMed 19204579American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
- Background: PubMed 15456348Asikainen TM, Kukkonen-Harjula K, Miilunpalo S. Exercise for health for early postmenopausal women: a systematic review of randomised controlled trials. Sports Med. 2004;34(11):753-78. doi: 10.2165/00007256-200434110-00004.
- Background: PubMed 25853878Benini R, Prado Nunes PR, Orsatti CL, Barcelos LC, Orsatti FL. Effects of acute total body resistance exercise on hormonal and cytokines changes in men and women. J Sports Med Phys Fitness. 2015 Apr;55(4):337-44.
- Background: PubMed 19150854Burnley M. Estimation of critical torque using intermittent isometric maximal voluntary contractions of the quadriceps in humans. J Appl Physiol (1985). 2009 Mar;106(3):975-83. doi: 10.1152/japplphysiol.91474.2008. Epub 2009 Jan 15.
- Background: PubMed 12473005Ferrucci L, Penninx BW, Volpato S, Harris TB, Bandeen-Roche K, Balfour J, Leveille SG, Fried LP, Md JM. Change in muscle strength explains accelerated decline of physical function in older women with high interleukin-6 serum levels. J Am Geriatr Soc. 2002 Dec;50(12):1947-54. doi: 10.1046/j.1532-5415.2002.50605.x.
- Background: PubMed 27350928Fink J, Kikuchi N, Yoshida S, Terada K, Nakazato K. Impact of high versus low fixed loads and non-linear training loads on muscle hypertrophy, strength and force development. Springerplus. 2016 May 20;5(1):698. doi: 10.1186/s40064-016-2333-z. eCollection 2016.
- Background: PubMed 22808712Gurjao AL, Gobbi LT, Carneiro NH, Goncalves R, Ferreira de Moura R, Cyrino ES, Altimari LR, Gobbi S. Effect of strength training on rate of force development in older women. Res Q Exerc Sport. 2012 Jun;83(2):268-75. doi: 10.1080/02701367.2012.10599857.
- Background: PubMed 16763836Klass M, Baudry S, Duchateau J. Voluntary activation during maximal contraction with advancing age: a brief review. Eur J Appl Physiol. 2007 Jul;100(5):543-51. doi: 10.1007/s00421-006-0205-x. Epub 2006 Jun 9.
- Background: PubMed 24739294Lera Orsatti F, Nahas EA, Maesta N, Nahas Neto J, Lera Orsatti C, Vannucchi Portari G, Burini RC. Effects of resistance training frequency on body composition and metabolics and inflammatory markers in overweight postmenopausal women. J Sports Med Phys Fitness. 2014 Jun;54(3):317-25.
- Background: PubMed 26941023Maffiuletti NA, Aagaard P, Blazevich AJ, Folland J, Tillin N, Duchateau J. Rate of force development: physiological and methodological considerations. Eur J Appl Physiol. 2016 Jun;116(6):1091-116. doi: 10.1007/s00421-016-3346-6. Epub 2016 Mar 3.
- Background: PubMed 17167161Marsh AP, Miller ME, Saikin AM, Rejeski WJ, Hu N, Lauretani F, Bandinelli S, Guralnik JM, Ferrucci L. Lower extremity strength and power are associated with 400-meter walk time in older adults: The InCHIANTI study. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1186-93. doi: 10.1093/gerona/61.11.1186.
- Individual participant dataSharing planned: No
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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.
Fabio L Orsatti, PhD principal investigator
Federal University of Triangulo Mineiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training, LL, Resistance training, HL and Resistance training, HVHL in people with Aging, run by Universidade Federal do Triangulo Mineiro 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabio L Orsatti, PhD (+55343700-6634, fabiorsatti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigability (time frame: Changes in fatigability measure (e.g. baseline and after 12 weeks of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03619070, which also lists 24 linked publications.
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 8 Aug 2018.