NCT03791502

Brief Summary

It will be an experimental study conducted with elderly of both sexes, these will be divided randomly into three groups and the intervention will happen twice a week, for 60 minutes, for 12 weeks. The aim of the study is to compare the effect of different volumes of Pilates exercise training on muscle strength, postural balance, flexibility, functional autonomy, depressive symptoms and lung function in the elderly community. The investigators believe that Pilates exercises will have beneficial effects for the elderly, but the hypothesis is that the group that performs a greater volume of Pilates exercise training will have a greater improvement in the investigated outcomes than the group with the lowest volume.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 2, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

November 7, 2018

Last Update Submit

February 1, 2020

Conditions

Keywords

Exercise Movement TechniquesElderlyMuscular StrengthPostural BalanceFlexibilityPilates

Outcome Measures

Primary Outcomes (7)

  • Change in muscle strength of lower limbs

    The Biofeedback System will be used for the practice of resistance exercises with elastic overload (E-lastic®). E-lastic® will measure maximal isometric voluntary contraction of the knee flexor and extensor muscles, flexors, extensors, adductors and hip abductors before and after the intervention. For the acquisition of force signals, a load cell is used to provide an electrical signal proportional to the force that deforms the equipment. The participants will perform 3 repetitions, maintaining the contraction for 5 seconds, with 60 seconds of recovery and the highest value will be recorded.

    12 weeks

  • change in muscle strength and resistance of lower limbs

    The 30-second chair stand test (30-s CST) will be used. It consists of getting up and sitting on a chair as many times as possible within 30 seconds. A seat with backrest and without armrest (with a seat height of 45 cm) is used. Initially, participants remain seated and are instructed to look forward after command "1, 2, 3, will" they raise with their arms crossed on their chest. The evaluator will explain and demonstrate the test and the participant will do once for familiarization. You will be given a rest of 2 minutes to start the test.

    12 weeks

  • Change in palmar grip strength

    Will be measured using the Saehan® hydraulic palmar gripper dynamometer, the position recommended by the American Society of Hand Therapists (ASHT) will be adopted: sitting comfortably positioned with shoulder lightly bent, elbow bent at 90 °, forearm in neutral position and, finally, the position of the handle may vary from 0 ° to 30 ° of extension. It will be used to record the maximum and average manual grip strength of three measurements and the values will be compared with the reference values.

    12 weeks

  • Change in static postural balance

    The static balance will be evaluated by measuring the time each participant can maintain in three progressively more difficult positions: semi-tandem, tandem and unipedal support. In all positions the individuals must be with their hands on their waist, the total time to stay in each position is 30 seconds and it will have 3 attempts in each position and the best time will be recorded. The evaluator will demonstrate the test once.

    12 weeks

  • Change in dynamic postural balance (TUG)

    To evaluate the dynamic balance, the Timed Up and Go Test (TUG) will be used. The TUG starts with the participant sitting in the chair, in the "go" command, he gets up from the chair, walks 3 meters at a comfortable pace, turns around, goes back to the chair and sits down. It will be demonstrated once and then it will do a repeat for familiarization.

    12 weeks

  • Change in dynamic postural balance (Step)

    To evaluate the dynamic balance, the Step Test will be used. The Alternative Step Test the participant is asked to make eight beats of foot, alternating between right and left, on a step in front of him with a height of 18 cm. Time will be timed and used in the analyzes. The test should be performed in 10 seconds.

    12 weeks

  • Change in flexibility

    To evaluate the flexibility of the hamstring muscles will be used the Sit and Go Test, using the Wells bench, participants will remain without footwear, sitting with knees extended, shoulders flexed, elbows extended and hands overlapped. Participants should perform trunk flexion at the front, perform a forced expiration, and move the seat ladder as far as possible, this procedure will be performed three times and immediately noted by the evaluator, with the best.

    12 weeks

Secondary Outcomes (6)

  • Functional Autonomy

    12 weeks

  • Depressive symptoms

    12 weeks

  • Change in respiratory muscle strength

    12 weeks

  • Change in pulmonary function (FVC)

    12 weeks

  • Change in pulmonary function (FEV1)

    12 weeks

  • +1 more secondary outcomes

Study Arms (3)

Pilates Method Exercises - lower volume

EXPERIMENTAL

The prescription will consist of 18 exercises, performed in a single series of seven to 10 repetitions, 60 seconds rest between exercises. Each week the exercises will be changed and the same exercise can only be repeated every three weeks. The progression will occur increasing the resistance of the springs and the level of difficulty of the exercises, but without modifying the repetitions. Training intensity will be measured using Modified Borg's Perceived Effort Scale and then kept moderate throughout the program.

Other: Pilates Method Exercises

Pilates Method Exercises - higher volume

EXPERIMENTAL

The participants will conduct a Pilates exercise program based on the recommendations of the American College Medicine of Sports. The prescription will consist of 12 exercises, performed in three sets of seven to ten repetitions and 60s of rest between sets. Every four weeks the exercises will be changed. The progression will occur increasing the resistance of the springs and the level of difficulty of the exercises. Training intensity will be measured using Modified Borg's Perceived Effort Scale and then kept moderate throughout the program.

Other: Pilates Method Exercises

Group control

NO INTERVENTION

The subjects allocated in the control group will remain with their usual activities, and after the reevaluation will be offered the intervention that presents the greater size of effect.

Interventions

Pilates Method exercises performed on the apparatus, on the ground and with accessories. They will always be performed by a physiotherapist with teaching certification in the Pilates methodology and will be supervised by two properly trained physiotherapy trainees. Participants will start the exercise program in small groups of up to 8 people, twice a week for 60 minutes, for 12 weeks, totaling 24 sessions. The first day of intervention for both groups will be devoted to explaining the six principles described by Joseph Pilates: centralization, concentration, control, precision, fluidity and breathing, and some fundamentals such as the neutral position of the spine. And in all sessions, these principles will be remembered by the physiotherapist.

Pilates Method Exercises - higher volumePilates Method Exercises - lower volume

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To present cognitive aptitude according to the Mental State Mini-Exam (MMSE)
  • Independent walking, without the use of auxiliary walking devices;
  • Not participating in other physical intervention research;
  • Not having undergone physiotherapeutic treatment and not having participated in a structured physical activity in the previous month;
  • Do not present neurological diseases, history of fractures or recent surgeries and serious cardiorespiratory diseases.

You may not qualify if:

  • Failure to attend all stages of evaluation;
  • They did not complete 80% of the intervention;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mônica Batista Duarte Caetano

Goiânia, Goiás, 74343530, Brazil

Location

Related Publications (22)

  • Nelson ME, Rejeski WJ, Blair SN, Duncan PW, Judge JO, King AC, Macera CA, Castaneda-Sceppa C; American College of Sports Medicine; American Heart Association. Physical activity and public health in older adults: recommendation from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1094-105. doi: 10.1161/CIRCULATIONAHA.107.185650. Epub 2007 Aug 1.

    PMID: 17671236BACKGROUND
  • Delmonico MJ, Harris TB, Lee JS, Visser M, Nevitt M, Kritchevsky SB, Tylavsky FA, Newman AB; Health, Aging and Body Composition Study. Alternative definitions of sarcopenia, lower extremity performance, and functional impairment with aging in older men and women. J Am Geriatr Soc. 2007 May;55(5):769-74. doi: 10.1111/j.1532-5415.2007.01140.x.

    PMID: 17493199BACKGROUND
  • Estrada M, Kleppinger A, Judge JO, Walsh SJ, Kuchel GA. Functional impact of relative versus absolute sarcopenia in healthy older women. J Am Geriatr Soc. 2007 Nov;55(11):1712-9. doi: 10.1111/j.1532-5415.2007.01436.x.

    PMID: 17979895BACKGROUND
  • Sturnieks DL, St George R, Lord SR. Balance disorders in the elderly. Neurophysiol Clin. 2008 Dec;38(6):467-78. doi: 10.1016/j.neucli.2008.09.001. Epub 2008 Oct 7.

    PMID: 19026966BACKGROUND
  • Milanovic Z, Pantelic S, Trajkovic N, Sporis G, Kostic R, James N. Age-related decrease in physical activity and functional fitness among elderly men and women. Clin Interv Aging. 2013;8:549-56. doi: 10.2147/CIA.S44112. Epub 2013 May 21.

    PMID: 23723694BACKGROUND
  • Stathokostas L, McDonald MW, Little RM, Paterson DH. Flexibility of older adults aged 55-86 years and the influence of physical activity. J Aging Res. 2013;2013:743843. doi: 10.1155/2013/743843. Epub 2013 Jun 19.

    PMID: 23862064BACKGROUND
  • de Oliveira Francisco C, de Almeida Fagundes A, Gorges B. Effects of Pilates method in elderly people: Systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jul;19(3):500-8. doi: 10.1016/j.jbmt.2015.03.003. Epub 2015 Mar 20.

    PMID: 26118523BACKGROUND
  • Irez GB, Ozdemir RA, Evin R, Irez SG, Korkusuz F. Integrating pilates exercise into an exercise program for 65+ year-old women to reduce falls. J Sports Sci Med. 2011 Mar 1;10(1):105-11. eCollection 2011.

    PMID: 24149302BACKGROUND
  • Bullo V, Bergamin M, Gobbo S, Sieverdes JC, Zaccaria M, Neunhaeuserer D, Ermolao A. The effects of Pilates exercise training on physical fitness and wellbeing in the elderly: A systematic review for future exercise prescription. Prev Med. 2015 Jun;75:1-11. doi: 10.1016/j.ypmed.2015.03.002. Epub 2015 Mar 12.

    PMID: 25773473BACKGROUND
  • Siqueira Rodrigues BG, Ali Cader S, Bento Torres NV, Oliveira EM, Martin Dantas EH. Pilates method in personal autonomy, static balance and quality of life of elderly females. J Bodyw Mov Ther. 2010 Apr;14(2):195-202. doi: 10.1016/j.jbmt.2009.12.005. Epub 2010 Jan 29.

    PMID: 20226367BACKGROUND
  • Mallery LH, MacDonald EA, Hubley-Kozey CL, Earl ME, Rockwood K, MacKnight C. The feasibility of performing resistance exercise with acutely ill hospitalized older adults. BMC Geriatr. 2003 Oct 7;3:3. doi: 10.1186/1471-2318-3-3.

    PMID: 14531932BACKGROUND
  • Bergamin M, Gobbo S, Bullo V, Zanotto T, Vendramin B, Duregon F, Cugusi L, Camozzi V, Zaccaria M, Neunhaeuserer D, Ermolao A. Effects of a Pilates exercise program on muscle strength, postural control and body composition: results from a pilot study in a group of post-menopausal women. Age (Dordr). 2015 Dec;37(6):118. doi: 10.1007/s11357-015-9852-3. Epub 2015 Nov 15.

    PMID: 26578458BACKGROUND
  • Markovic G, Sarabon N, Greblo Z, Krizanic V. Effects of feedback-based balance and core resistance training vs. Pilates training on balance and muscle function in older women: a randomized-controlled trial. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):117-23. doi: 10.1016/j.archger.2015.05.009. Epub 2015 May 27.

    PMID: 26036209BACKGROUND
  • Oliveira LC, Pires-Oliveira DA, Abucarub AC, Oliveira LS, Oliveira RG. Pilates increases isokinetic muscular strength of the elbow flexor and extensor muscles of older women: A randomized controlled clinical trial. J Bodyw Mov Ther. 2017 Jan;21(1):2-10. doi: 10.1016/j.jbmt.2016.03.002. Epub 2016 Mar 10.

    PMID: 28167180BACKGROUND
  • Borde R, Hortobagyi T, Granacher U. Dose-Response Relationships of Resistance Training in Healthy Old Adults: A Systematic Review and Meta-Analysis. Sports Med. 2015 Dec;45(12):1693-720. doi: 10.1007/s40279-015-0385-9.

    PMID: 26420238BACKGROUND
  • Neri AL, Ongaratto LL, Yassuda MS. Mini-Mental State Examination sentence writing among community-dwelling elderly adults in Brazil: text fluency and grammar complexity. Int Psychogeriatr. 2012 Nov;24(11):1732-7. doi: 10.1017/S104161021200097X. Epub 2012 Jul 5.

    PMID: 22874587BACKGROUND
  • Barker AL, Talevski J, Bohensky MA, Brand CA, Cameron PA, Morello RT. Feasibility of Pilates exercise to decrease falls risk: a pilot randomized controlled trial in community-dwelling older people. Clin Rehabil. 2016 Oct;30(10):984-996. doi: 10.1177/0269215515606197. Epub 2015 Sep 18.

    PMID: 26385357BACKGROUND
  • Bird ML, Fell J. Positive long-term effects of Pilates exercise on the aged-related decline in balance and strength in older, community-dwelling men and women. J Aging Phys Act. 2014 Jul;22(3):342-7. doi: 10.1123/japa.2013-0006. Epub 2013 Aug 6.

    PMID: 23921206BACKGROUND
  • Oliveira LC, Oliveira RG, Pires-Oliveira DA. Comparison between static stretching and the Pilates method on the flexibility of older women. J Bodyw Mov Ther. 2016 Oct;20(4):800-806. doi: 10.1016/j.jbmt.2016.01.008. Epub 2016 Feb 3.

    PMID: 27814860BACKGROUND
  • Lord SR, Menz HB, Tiedemann A. A physiological profile approach to falls risk assessment and prevention. Phys Ther. 2003 Mar;83(3):237-52.

    PMID: 12620088BACKGROUND
  • McCarthy EK, Horvat MA, Holtsberg PA, Wisenbaker JM. Repeated chair stands as a measure of lower limb strength in sexagenarian women. J Gerontol A Biol Sci Med Sci. 2004 Nov;59(11):1207-12. doi: 10.1093/gerona/59.11.1207.

    PMID: 15602077BACKGROUND
  • Wells C, Kolt GS, Bialocerkowski A. Defining Pilates exercise: a systematic review. Complement Ther Med. 2012 Aug;20(4):253-62. doi: 10.1016/j.ctim.2012.02.005. Epub 2012 Mar 13.

    PMID: 22579438BACKGROUND

Study Officials

  • Mônica D Caetano

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Subjects will be randomized into three groups, two intervention groups and one group will be the control. The randomization process will be done by a person who does not participate in the survey, at random.org, and concealment of the allocation will occur using opaque and sealed envelopes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Student of the Post-graduation Program in Rehabilitation Sciences da University de Brasilia

Study Record Dates

First Submitted

November 7, 2018

First Posted

January 2, 2019

Study Start

March 11, 2019

Primary Completion

October 2, 2019

Study Completion

December 2, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations