Multicomponent vs Pilates on Mass, Strength, and Physical Performance in Older Adults

NCT06719505 | Not Yet Recruiting DMC

• 1 other identifier: Multicomponent vs Pilates
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The aging process can result in several physiological changes, such as the loss of muscle mass, muscle strength, and physical performance, collectively defined as sarcopenia. Sarcopenia is considered one of the primary health challenges among older adults. To prevent this condition and improve related health outcomes, regular physical exercise is the most recommended strategy, with multicomponent exercises being particularly effective for older individuals. Pilates is another potential form of physical exercise that has gained popularity among older adults seeking to improve muscle mass, strength, and physical performance. However, significant gaps remain in the literature, with a notable lack of studies evaluating the efficacy of Pilates in improving sarcopenic outcomes. Objective: To compare the efficacy of multicomponent training programs versus Pilates in improving muscle mass, muscle strength, and physical performance in older adults. Methods: A total of 100 older adults aged 60 to 80 years, of both sexes, will be randomized into two intervention groups: the Multicomponent Training Group (n=50) and the Pilates Group (n=50). Evaluations will be conducted at three time points: baseline (before the intervention), mid-treatment (3 months), and post-treatment (6 months). The following instruments will be used: Dual-energy X-ray absorptiometry (DXA) will be used to assess muscle mass. Muscle strength will be evaluated using an isokinetic dynamometer for the lower limbs and a handgrip dynamometer for the upper limbs. Physical performance will be assessed through the Brazilian version of the Short Physical Performance Battery (SPPB), the gait speed test, and the Timed Up and Go (TUG) test. The Feeling Scale will be applied to determine the affective valence of the exercise programs. The Shapiro-Wilk test will be performed to check the normality of the data, Student's t-test or Mann-Whitney U test will be used depending on whether the distribution is parametric or non-parametric, and ANCOVA will be used to compare the groups post-intervention, considering a 95% confidence interval (p\<0.05). The data will be analyzed using SPSS 25.0 software.

Conditions

Muscle Mass; Muscle Strength; Physical Performance

Keywords

Aging; Elderly; Fragility; Physical exercise; Sarcopenia

Outcome Measures

Primary Outcomes (6)

• 1. Dual-energy X-ray absorptiometry (DXA)

  A high-precision reference standard used to measure lean muscle mass. The values will be calculated by the ratio of appendicular lean mass divided by the square of height in meters, with values lower than 7 kg/m² for men and 5.5 kg/m² for women confirming the diagnosis of low lean mass.

  6 months

• 2. Biodex Isokinetic Dynamometer System

  Evaluation of isokinetic muscle strength of the knee extensors and flexors. The assessment consists of knee extension and flexion (concentric/concentric) at an angular velocity of 60°/s, starting with the knee flexed at 90°. Three sets of five repetitions will be performed with a 30-second rest interval between sets, and the same procedure will be carried out with the left leg.

  6 months

• 3. Hydraulic Hand Dynamometer

  Evaluation of handgrip strength. The best value from three attempts will be used for each hand.

  6 months

• 4. Brazilian Version of the Short Physical Performance Battery (SPPB)

  A battery of tests to assess physical performance, including balance, gait speed, and chair rise tests. It has predictive validity and clinical applicability.

  6 months

• 5. Gait Speed Test: Evaluation of gait speed through the 4-meter Walking Speed Test and the 6-Minute Walk Test (6MWT)

  The 4-meter Walking Speed Test is used as a short-distance gait speed test, measuring habitual or maximum speed manually with a stopwatch or electronically with a device to measure the individual's walking time over a four-meter course. The 6MWT is a submaximal measure of aerobic capacity. Both tests are used to assess physical performance

  6 months

• 6. Timed Up and Go (TUG)

  A test used to assess physical function, commonly employed to evaluate the risk of falls. For the test, the time it takes for participants to rise from a chair, walk at a comfortable pace in a straight line for three meters, turn around, and return to the chair to sit down will be timed.

  6 months

Secondary Outcomes (3)

• 7. Simple questionnaire to rapidly diagnose sarcopenia (SARC-F)

  6 months

• 8. Mini Nutritional Assessment (MNA)

  6 months

• 9. Feeling Scale - Pleasure and Displeasure during Exercise

  6 months

Study Arms (2)

Multicomponent exercises (ME)

ACTIVE COMPARATOR

The interventions for the ME group will consist of exercises for aerobic training, strengthening, resistance, balance, and flexibility. The first week of the protocol will be dedicated to familiarizing the volunteers with the exercises, during which the correct execution of the movements will be demonstrated. Resources such as dumbbells, ankle weights, elastic bands, resistance bands, sticks, obstacles, and balls will be used.

Other: ME

Pilates exercises (PE)

EXPERIMENTAL

For the intervention of the PE group, the first week of the protocol will be used to familiarize participants with the exercises, during which the correct execution of the movements will be demonstrated and each principle of the method will be explained: concentration, centering, precision, breathing, control, and fluidity. Regarding the progression of spring resistance, it will occur according to the volunteers' progress by switching to a spring with higher resistance (changing the position of the springs on the equipment or replacing them with ones of higher resistance). The basic equipment used will include the Cadillac Trapeze, Combo Chair, Universal Reformer, Ladder Barrel, and Wall Unit.

Other: PE

Interventions

ME OTHER

Exercises selected with a focus on the major muscle groups. There will be one protocol for the first 3 months and a second protocol for months 4-6, with the number of repetitions for each exercise varying from 3 sets of 8 to 10 repetitions, totaling 18 exercises.

Multicomponent exercises (ME)

PE OTHER

The stretching and strengthening exercises will target the major muscle groups, and at the end of each session (lasting approximately 60 minutes), the instructor will guide the participant through a relaxation exercise using an EVA foam roller. The exercises were selected to improve overall muscle strength, as traditionally applied in Pilates. There will be one protocol for the first 3 months and a second protocol for months 4-6, with 17 exercises in each protocol, varying from 3 sets of 8 to 10 repetitions.

Pilates exercises (PE)

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Not currently participating in a physical training program for at least six months;
• No medical restrictions for physical activity and physical tests;
• Achieve a score of 19 or higher on the Mini-Mental State Examination.

You may not qualify if:

• Individuals with severe/disabling musculoskeletal and/or neurological dysfunctions;
• Neurological disorders or cognitive impairment;
• Use of supplements for muscle mass increase;
• History of recent fractures or surgeries and severe cardiorespiratory diseases.

Sponsors & Collaborators

• Universidade Estadual do Norte do Parana: lead

Study Sites (1)

Universidade

Jacarezinho, Paraná, 86400-000, Brazil

Location

Related Publications (10)

• Bottaro M, Russo AF, de Oliveira RJ. The effects of rest interval on quadriceps torque during an isokinetic testing protocol in elderly. J Sports Sci Med. 2005 Sep 1;4(3):285-90. eCollection 2005 Sep 1.

  PMID: 24453533 BACKGROUND

• Buckinx F, Aubertin-Leheudre M. Relevance to assess and preserve muscle strength in aging field. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Aug 30;94:109663. doi: 10.1016/j.pnpbp.2019.109663. Epub 2019 Jun 7.

  PMID: 31176745 BACKGROUND

• Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.

  PMID: 31171417 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters DL, Won Won C, Woo J, Vellas B, Fiatarone Singh M. International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. J Nutr Health Aging. 2021;25(7):824-853. doi: 10.1007/s12603-021-1665-8.

  PMID: 34409961 BACKGROUND

• Kaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony P, Charlton KE, Maggio M, Tsai AC, Grathwohl D, Vellas B, Sieber CC; MNA-International Group. Validation of the Mini Nutritional Assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging. 2009 Nov;13(9):782-8. doi: 10.1007/s12603-009-0214-7.

  PMID: 19812868 BACKGROUND

• Mehmet H, Yang AWH, Robinson SR. Measurement of hand grip strength in the elderly: A scoping review with recommendations. J Bodyw Mov Ther. 2020 Jan;24(1):235-243. doi: 10.1016/j.jbmt.2019.05.029. Epub 2019 May 24.

  PMID: 31987550 BACKGROUND

• Melo MO, Gomes LE, Silva YO, Bonezi A, Loss JF. Assessment of resistance torque and resultant muscular force during Pilates hip extension exercise and its implications to prescription and progression. Rev Bras Fisioter. 2011 Jan-Feb;15(1):23-30.

  PMID: 21519714 BACKGROUND

• 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: 28167180 BACKGROUND

• Seo MW, Jung SW, Kim SW, Lee JM, Jung HC, Song JK. Effects of 16 Weeks of Resistance Training on Muscle Quality and Muscle Growth Factors in Older Adult Women with Sarcopenia: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jun 23;18(13):6762. doi: 10.3390/ijerph18136762.

  PMID: 34201810 BACKGROUND

Related Links

• Approval of the Ethics Committee for Research with Human Beings in Brazil

MeSH Terms

Conditions

Motor Activity; Sarcopenia

Condition Hierarchy (Ancestors)

Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Laís C. de Oliveira, PhD

  UENP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Clara F. Lucio, PT

CONTACT

(55)15 997667410; mariaclaraitapo@gmail.com

Raphael G. de Oliveira, PhD

CONTACT

(55) 43 996417628; rgoliveira@uenp.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The sample randomization will be conducted secretly by a professional who is unaware of the study and the volunteers. This professional will perform the randomization using random numbers to assign the study sample into two groups: the Multicomponent Group (EM) (n=50) and the Pilates Group (EP) (n=50). The same professional will then place the assignments in opaque envelopes, which will be sealed and contain the group allocation inside. Participants will be informed that they may be allocated to either group during the recruitment and selection process. Moreover, both the participants and the researchers will only know which group each individual is assigned to at the moment of envelope delivery. Assessments will be conducted before the intervention, during the treatment (3 months), and after its completion (6 months) by the same professional, who will be blinded to the identities of the volunteers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Teacher Laís Campos de Oliveira

Model Details: The interventions will last for six months, three times per week, for one hour, on non-consecutive days. The interventions for the Multicomponent group will consist of exercises for aerobic training, strengthening, resistance, balance, and flexibility, with one protocol for the first 3 months and a second protocol for months 4-6. The number of repetitions for each exercise will range from 3 sets of 8 to 10 repetitions, totaling 18 exercises. The Pilates exercise group will perform stretching and strengthening exercises targeting the main muscle groups, with one protocol for the first 3 months and a second protocol for months 4-6. Each protocol will consist of 17 exercises, with 3 sets of 8 to 10 repetitions.

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)