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

December 9, 2024 updated by: Laís Campos de Oliveira, Universidade Estadual do Norte do Parana

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Brazil
    • Paraná
      • Jacarezinho, Paraná, Brazil, 86400-000
        • Universidade
        • Contact:
        • Principal Investigator:
          • Laís C. de Oliveira, PhD
        • Principal Investigator:
          • Raphael G. de Oliveira, PhD
        • Principal Investigator:
          • Maria Clara F. Lucio, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
4. Brazilian Version of the Short Physical Performance Battery (SPPB)
Time Frame: 6 months
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)
Time Frame: 6 months
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
1. Dual-energy X-ray absorptiometry (DXA)
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
Evaluation of handgrip strength. The best value from three attempts will be used for each hand.
6 months
6. Timed Up and Go (TUG)
Time Frame: 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
9. Feeling Scale - Pleasure and Displeasure during Exercise
Time Frame: 6 months
The affective valence scale will be used to measure participants' feelings of pleasure/affect related to the exercises. The score ranges from +5, indicating pleasure during exercise with a feeling of "very good," to -5, indicating displeasure with a feeling of "very bad" during exercise execution. The closer the score is to +5, the more pleasure the participant experiences while performing the exercise.
6 months
7. Simple questionnaire to rapidly diagnose sarcopenia (SARC-F)
Time Frame: 6 months
It is a validated and consistent questionnaire to identify people at risk of adverse outcomes due to sarcopenia. It consists of 5 items, self-reported by patients, based on the individual's perception of their strength limitations, ability to walk, get up from a chair, climb stairs and history of falls. Each item can be scored from 0 to 2, with 0 being no difficulty, 1 being some difficulty, and 2 being very difficult or unable to perform. In the falls item, 0 corresponds to no falls, 1 corresponds to 1 to 3 falls and 2 corresponds to 4 or more falls. The final score can range from 0 to 10, with a score of 4 being considered predictive of sarcopenia.
6 months
8. Mini Nutritional Assessment (MNA)
Time Frame: 6 months
A screening tool for the nutritional status of participants, consisting of simple measures and six questions that can be answered in less than 5 minutes. It includes anthropometric measurements (body mass index, weight loss), global assessment (mobility), and dietary questionnaire and subjective evaluation (food intake, neuropsychological issues, acute illness). A score between 12-14 points indicates normal nutrition, 8-11 points indicates a risk of malnutrition, and 0-7 points indicates malnutrition.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Estadual do Norte do Parana

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laís C. de Oliveira, PhD, UENP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Multicomponent vs Pilates

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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