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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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The sample will consist of 100 elderly individuals of both sexes, aged between 60 and 80 years. The sample size calculation for this study was performed using the Bioestat 5.3 program, based on the values of whole-body DEXA (dual-energy X-ray absorptiometry) assessment, provided in a previous study (Seo et al., 2021). In this case, the post-intervention mean and standard deviation between the Resistance Training group (1566.75±189.47) and the Control group (maintaining routine habits) (1446.86 ± 206.42) were used, with a test power of 80%, an alpha value of 0.05, and a 15% error rate, which indicated the need for 50 participants in each group (Multicomponent Group and Pilates Group). Descriptive data analysis will be expressed as mean, standard deviation, and percentage delta of the difference. Normality will be assessed using the Shapiro-Wilk test. To verify if there are differences between the groups regarding baseline characteristics (age, weight, height, and BMI) at the pre-intervention stage, Student's t-test for independent samples or the Mann-Whitney U test will be used, depending on whether the data are parametric or non-parametric. To compare the groups post-intervention, ANCOVA will be used, with baseline data as covariates. If the data exhibit non-parametric characteristics, the Mann-Whitney U test will be applied to compare the groups based on the difference between pre- and post-intervention. A confidence interval of 95% (p\<0.05) will be accepted. Data will be processed using SPSS 25.0 software. Effect sizes (Cohen's d) will be calculated and classified as small (0.20), medium (0.50), or large (0.80). For effect size calculations, the GPower 3.1 program will be used.

Conditions

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Muscle Mass Muscle Strength Physical Performance

Keywords

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Aging Elderly Fragility Physical exercise Sarcopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Multicomponent exercises (ME)

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.

Group Type ACTIVE_COMPARATOR

ME

Intervention Type 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.

Pilates exercises (PE)

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.

Group Type EXPERIMENTAL

PE

Intervention Type 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.

Interventions

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ME

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.

Intervention Type OTHER

PE

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Laís Campos de Oliveira

Doctor Teacher Laís Campos de Oliveira

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laís C. de Oliveira, PhD

Role: PRINCIPAL_INVESTIGATOR

UENP

Locations

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Universidade

Jacarezinho, Paraná, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Maria Clara F. Lucio, PT

Role: CONTACT

Phone: (55)15 997667410

Email: [email protected]

Raphael G. de Oliveira, PhD

Role: CONTACT

Phone: (55) 43 996417628

Email: [email protected]

Facility Contacts

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Laís C. de Oliveira, PhD

Role: primary

References

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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.

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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.

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Reference Type BACKGROUND

PMID: 34201810 (View on PubMed)

Other Identifiers

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