NCT03619070

Brief Summary

This study evaluate whether resistance training variables modulate the fatigability (power-duration relationship) and physical performance in adults and older adults

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

August 1, 2018

Last Update Submit

August 6, 2018

Conditions

Keywords

FatigabilityPostmenopausal WomanResistance trainingPhysical performanceOlder adults

Outcome Measures

Primary Outcomes (1)

  • Fatigability

    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 Outcomes (1)

  • Physical Performance

    Changes in physical performance measure (e.g. baseline and after 12 weeks of intervention)

Other Outcomes (2)

  • Body composition

    Changes in body composition (e.g. baseline and after 12 weeks of intervention)

  • Muscle strength

    Changes in muscle strength (e.g. baseline and after 12 weeks of intervention)

Study Arms (4)

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)

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)

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)

Other: Resistance training, HVHL

Control group, (CG)

OTHER

In CG, the postmenopausal women group will not perform exercise

Other: Control group, CG

Interventions

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)

Lower load resistance training (LL)

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)

Higher load resistance training (HL)

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)

Higher volume resistance training (HVHL)

The CG groups do not will performed the exercise.

Control group, (CG)

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women (\>12 months amenorrhea) with age above or equal 50 years old.
  • No hormone therapy or phytoestrogens

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post-degree program in physical education

Uberaba, MG - Minas Gerais, 38061-500, Brazil

RECRUITING

Related Publications (24)

  • 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.

    PMID: 12235031BACKGROUND
  • 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.

    PMID: 19204579BACKGROUND
  • 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.

    PMID: 15456348BACKGROUND
  • 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.

    PMID: 25853878BACKGROUND
  • 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.

    PMID: 19150854BACKGROUND
  • 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.

    PMID: 12473005BACKGROUND
  • 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.

    PMID: 27350928BACKGROUND
  • 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.

    PMID: 22808712BACKGROUND
  • 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.

    PMID: 16763836BACKGROUND
  • 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.

    PMID: 24739294BACKGROUND
  • 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.

    PMID: 26941023BACKGROUND
  • 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.

    PMID: 17167161BACKGROUND
  • 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.

    PMID: 16410852BACKGROUND
  • 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.

    PMID: 20060626BACKGROUND
  • 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.

    PMID: 26984105BACKGROUND
  • 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.

    PMID: 28135215BACKGROUND
  • 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.

    PMID: 28804047BACKGROUND
  • 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.

    PMID: 28604135BACKGROUND
  • 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.

    PMID: 18499368BACKGROUND
  • 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.

    PMID: 21986696BACKGROUND
  • 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.

    PMID: 19415539BACKGROUND
  • 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.

    PMID: 21388496BACKGROUND
  • 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.

    PMID: 27031742BACKGROUND
  • 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.

    PMID: 11856064BACKGROUND

MeSH Terms

Interventions

Resistance TrainingControl Groups

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Fabio L Orsatti, PhD

    Federal University of Triangulo Mineiro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio L Orsatti, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 7, 2018

Study Start

May 20, 2018

Primary Completion

September 30, 2018

Study Completion

November 15, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations