NCT06719505

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

Comparison Between a Multicomponent Training Program and Pilates on Muscle Mass, Muscle Strength, and Physical Performance in Older Adults: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universidade Estadual do Norte do Parana · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

• Muscle Mass
• Muscle Strength
• Physical Performance

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2024-12-05
• Last updated: 2024-12-13

Locations

1 site across 1 country: Brazil