Multicomponent vs Pilates on Mass, Strength, and Physical Performance in Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorUniversidade Estadual do Norte do Parana
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
ME
Other interventionExercises 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.
PE
Other interventionThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Multicomponent exercises (ME)Active comparator 1 intervention
Group B: Pilates exercises (PE)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months2
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.
Time frame
6 months3
3. Hydraulic Hand Dynamometer
Evaluation of handgrip strength. The best value from three attempts will be used for each hand.
Time frame
6 months4
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.
Time frame
6 monthsSecondary outcomes
1
7. Simple questionnaire to rapidly diagnose sarcopenia (SARC-F)
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.
Time frame
6 months2
8. Mini Nutritional Assessment (MNA)
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.
Time frame
6 months3
9. Feeling Scale - Pleasure and Displeasure during Exercise
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.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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