Clinical trial NCT03791502: Effect of Different Volumes of Training of Pilates Exercises on Elderly
Official title: Effect of Different Volumes of Training of Pilates Exercises on Muscle Strength, Postural Balance, Flexibility, Functional Autonomy, Depressive Symptoms and Pulmonary Function on Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Exercise Movement Techniques
Keywords: Exercise Movement Techniques
Elderly
Muscular Strength
Postural Balance
Flexibility
Pilates
Lead sponsor: University of Brasilia
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized into three groups, two intervention groups and one group will be the control. The randomization process will be done by a person who does not participate in the survey, at random.org, and concealment of the allocation will occur using opaque and sealed envelopes.
Primary purpose: SUPPORTIVE_CARE

Brief summary: It will be an experimental study conducted with elderly of both sexes, these will be divided randomly into three groups and the intervention will happen twice a week, for 60 minutes, for 12 weeks. The aim of the study is to compare the effect of different volumes of Pilates exercise training on muscle strength, postural balance, flexibility, functional autonomy, depressive symptoms and lung function in the elderly community. The investigators believe that Pilates exercises will have beneficial effects for the elderly, but the hypothesis is that the group that performs a greater volume of Pilates exercise training will have a greater improvement in the investigated outcomes than the group with the lowest volume.

Detailed description: Aging is an involuntary and progressive process that leads to biological, structural and functional changes such as loss of mass and muscle strength. The aging process leads to changes in the visual, vestibular, sensory and motor systems, causing slow reaction time, compromising the postural balance. Flexibility and mobility also tend to decrease with aging favoring the onset of lesions and loss of functional autonomy. The regular practice of physical exercise helps to prevent these changes related to aging. Among the various possibilities of physical exercise, the Pilates method has been well-suited for the elderly, since it incorporates the training components recommended by the American College of Sports Medicine (ACSM), is the strength, balance, and flexibility. However, researchers have questioned the lack of scientific evidence that confirms all the benefits of the method, especially in the elderly. The findings described in the literature are still controversial. A systematic review of six randomized controlled trials (RCTs) has shown limited evidence in improving strength, flexibility, and balance in both sexes.

Physical decline negatively affects the personal autonomy and quality of life of the elderly and Pilates seems to have positive effects on these aspects. Rodrigues et al. (2010) observed a significant evolution in the functional performance of healthy elderly women in rising from the seated position (11.8%) and lying position (26%) and a significant improvement in quality of life (p = 0.04) after intervention with Pilates exercises . As for depressive symptoms, Mokhtari et al. (2013) identified a significant reduction (p \<0.007) in this symptomatology after Pilates practice. However, both studies reached only two points on the PEDro Scale. Recent investigations found a significant increase in maximal inspiratory pressure (MIP) of 19.5%, maximal expiratory pressure (MEP) of 8.7% and Abdominal Transversal thickness of 42.3% after the program. However, the study presented some limitations, such as the absence of a control group and the inability of the blindness of the evaluators.

It is also important to highlight the lack of reports on how the programs are carried out and when there is a description there is a heterogeneity in the prescription of the exercises. In the two reviews cited above, only two of the included studies presented the prescribed volume: ten replicates and three series of ten repetitions. Some studies have also described the volume: two sets of ten repetitions, two to four sets of 15 to 20 seconds of contraction for isometric exercises and 15 to 20 repetitions for dynamic exercises. A single series of 10 replicates with a 30-second interval between the series. It is known that the literature suggests for the muscular strength gain in the elderly a training volume of two to three sets per exercise, seven to ten repetitions per set and a moderate to high intensity and as noted most Pilates exercise programs have not followed these recommendations. The aim of the study is to compare the effect of different volumes of Pilates exercise training on muscle strength, postural balance, flexibility, functional autonomy, depressive symptoms and lung function in the elderly community.

The elderly will be invited through advertisements in social networks, local media, and posters distributed in the centers for the coexistence of the elderly, health centers and churches. Initially, each individual who agrees to participate in the study will sign the Free and Informed Consent Form. Next, the investigators will collect the data referring to the variables: cognitive aptitude, sociodemographic, clinical characterization, and anthropometric measurements. All participants will be evaluated for muscle strength, balance, flexibility, functional autonomy, depression and lung function before and after the intervention, including those who do not complete 80% of their presence during the intervention period. For the self-report questionnaires an evaluator will be trained and for the performance questionnaires/tests two evaluators will be trained and they will be blind to the intervention.

The risks of participating in the research are: the participants feel embarrassed in some interview questions, present some imbalance and risk of falls, muscle aches and increased blood pressure (BP) and heart rate (HR). However, to minimize them, the participant may refuse to answer any of the questions and interrupt the interview, as each position of the balance tests the interviewer will first demonstrate the task, then support the participants and only withdraw support after the consent of the participant, always standing next to it. The stretching will be performed in case of muscle discomfort and the monitoring of cardiorespiratory variables will be done.

How much of the benefits will participants be contributing to a greater knowledge about the effects of Pilates exercises in the elderly, the results obtained with the research will favor the formulation of adequate exercise programs and an improvement of care for the elderly, improving the quality of care, in the prevention of functional problems and falls. In addition, participants will have a thorough assessment of their overall health, well-being, and physical and functional aspects and may improve the deficiencies presented by performing Pilates exercises. Pilates will promote improved strength, muscular flexibility and well-being and provide socialization.

Eligibility criteria: Inclusion Criteria:

* To present cognitive aptitude according to the Mental State Mini-Exam (MMSE)
* Independent walking, without the use of auxiliary walking devices;
* Not participating in other physical intervention research;
* Not having undergone physiotherapeutic treatment and not having participated in a structured physical activity in the previous month;
* Do not present neurological diseases, history of fractures or recent surgeries and serious cardiorespiratory diseases.

Exclusion Criteria:

* Failure to attend all stages of evaluation;
* They did not complete 80% of the intervention;

Primary outcomes:
measure: Change in muscle strength of lower limbs
timeFrame: 12 weeks
measure: change in muscle strength and resistance of lower limbs
timeFrame: 12 weeks
measure: Change in palmar grip strength
timeFrame: 12 weeks
measure: Change in static postural balance
timeFrame: 12 weeks
measure: Change in dynamic postural balance (TUG)
timeFrame: 12 weeks
measure: Change in dynamic postural balance (Step)
timeFrame: 12 weeks
measure: Change in flexibility
timeFrame: 12 weeks
Secondary outcomes:
measure: Functional Autonomy
timeFrame: 12 weeks
measure: Depressive symptoms
timeFrame: 12 weeks
measure: Change in respiratory muscle strength
timeFrame: 12 weeks
measure: Change in pulmonary function (FVC)
timeFrame: 12 weeks
measure: Change in pulmonary function (FEV1)
timeFrame: 12 weeks
measure: Change in pulmonary function (FEV1 / FVC ratio)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Mônica Batista Duarte Caetano
state: Goiás
Study officials:
affiliation: University of Brasilia
name: Mônica D Caetano
role: PRINCIPAL_INVESTIGATOR
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