- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03619070
Fatigability and Physical Performance: Effects of Resistance Training Variables Manipulation
August 6, 2018 updated by: Fábio Lera Orsatti, Universidade Federal do Triangulo Mineiro
This study evaluate whether resistance training variables modulate the fatigability (power-duration relationship) and physical performance in adults and older adults
Study Overview
Status
Unknown
Conditions
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 Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
MG - Minas Gerais
-
Uberaba, MG - Minas Gerais, Brazil, 38061-500
- Recruiting
- Post-degree program in physical education
-
Contact:
- Fabio L Orsatti
- Phone Number: +55 34 3700-6634
- Email: fabiorsatti@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Postmenopausal women (>12 months amenorrhea) with age above or equal 50 years old.
- No hormone therapy or phytoestrogens
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Lower load resistance training (LL)
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)
|
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)
|
|
EXPERIMENTAL: Higher load resistance training (HL)
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)
|
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)
|
|
EXPERIMENTAL: Higher volume resistance training (HVHL)
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)
|
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)
|
|
OTHER: Control group, (CG)
In CG, the postmenopausal women group will not perform exercise
|
The CG groups do not will performed the exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Changes in fatigability measure (e.g. baseline and after 12 weeks of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Performance
Time Frame: Changes in physical performance measure (e.g. baseline and after 12 weeks of intervention)
|
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).
|
Changes in physical performance measure (e.g. baseline and after 12 weeks of intervention)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition
Time Frame: Changes in body composition (e.g. baseline and after 12 weeks of intervention)
|
The body composition will be evaluate by dual-energy X-ray absorptiometry (DXA).
|
Changes in body composition (e.g. baseline and after 12 weeks of intervention)
|
|
Muscle strength
Time Frame: Changes in muscle strength (e.g. baseline and after 12 weeks of intervention)
|
Muscle strength will be assess in all subjects, by the one-repetition maximum (1-RM) test, for dynamic exercises.
The 1-RM is defined as the maximal weight that is lifted with proper body alignment and correct lifting technique.
|
Changes in muscle strength (e.g. baseline and after 12 weeks of intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- American 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.
- Muscaritoli 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.
- Poole DC, Burnley M, Vanhatalo A, Rossiter HB, Jones AM. Critical Power: An Important Fatigue Threshold in Exercise Physiology. Med Sci Sports Exerc. 2016 Nov;48(11):2320-2334. doi: 10.1249/MSS.0000000000000939.
- 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.
- Asikainen 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.
- Benini 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.
- Burnley 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.
- Ferrucci 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.
- Fink 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.
- Gurjao 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.
- Klass 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.
- Lera 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.
- Maffiuletti 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.
- Marsh 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.
- Masson 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.
- Nunes 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.
- Nunes PRP, Barcelos LC, Oliveira AA, Furlanetto R Jr, Martins FM, Resende EAMR, Orsatti FL. Muscular Strength Adaptations and Hormonal Responses After Two Different Multiple-Set Protocols of Resistance Training in Postmenopausal Women. J Strength Cond Res. 2019 May;33(5):1276-1285. doi: 10.1519/JSC.0000000000001788.
- Nunes PRP, Oliveira AA, Martins FM, Souza AP, Orsatti FL. Effect of resistance training volume on walking speed performance in postmenopausal women: A randomized controlled trial. Exp Gerontol. 2017 Oct 15;97:80-88. doi: 10.1016/j.exger.2017.08.011. Epub 2017 Aug 10.
- Orsatti FL, Maesta N, de Oliveira EP, Nahas Neto J, Burini RC, Nunes PRP, Souza AP, Martins FM, Nahas EP. Adding Soy Protein to Milk Enhances the Effect of Resistance Training on Muscle Strength in Postmenopausal Women. J Diet Suppl. 2018 Mar 4;15(2):140-152. doi: 10.1080/19390211.2017.1330794. Epub 2017 Jun 12.
- Orsatti FL, Nahas EA, Maesta N, Nahas-Neto J, Burini RC. Plasma hormones, muscle mass and strength in resistance-trained postmenopausal women. Maturitas. 2008 Apr 20;59(4):394-404. doi: 10.1016/j.maturitas.2008.04.002. Epub 2008 May 21.
- Orsatti FL, Nahas EA, Orsatti CL, de Oliveira EP, Nahas-Neto J, da Mota GR, Burini RC. Muscle mass gain after resistance training is inversely correlated with trunk adiposity gain in postmenopausal women. J Strength Cond Res. 2012 Aug;26(8):2130-9. doi: 10.1519/JSC.0b013e318239f837.
- Petri Nahas EA, Padoani NP, Nahas-Neto J, Orsatti FL, Tardivo AP, Dias R. Metabolic syndrome and its associated risk factors in Brazilian postmenopausal women. Climacteric. 2009 Oct;12(5):431-8. doi: 10.1080/13697130902718168.
- Pollanen E, Sipila S, Alen M, Ronkainen PH, Ankarberg-Lindgren C, Puolakka J, Suominen H, Hamalainen E, Turpeinen U, Konttinen YT, Kovanen V. Differential influence of peripheral and systemic sex steroids on skeletal muscle quality in pre- and postmenopausal women. Aging Cell. 2011 Aug;10(4):650-60. doi: 10.1111/j.1474-9726.2011.00701.x. Epub 2011 Apr 12.
- Steffen TM, Hacker TA, Mollinger L. Age- and gender-related test performance in community-dwelling elderly people: Six-Minute Walk Test, Berg Balance Scale, Timed Up & Go Test, and gait speeds. Phys Ther. 2002 Feb;82(2):128-37. doi: 10.1093/ptj/82.2.128.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 20, 2018
Primary Completion (ANTICIPATED)
September 30, 2018
Study Completion (ANTICIPATED)
November 15, 2018
Study Registration Dates
First Submitted
August 1, 2018
First Submitted That Met QC Criteria
August 1, 2018
First Posted (ACTUAL)
August 7, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 8, 2018
Last Update Submitted That Met QC Criteria
August 6, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 85052218.0.0000.5154
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.