A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women

Study Overview
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Brief Summary
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This study is based on assess and contrast isometric and isokinetic core strength, static and dynamic balance, the number of falls, and functional autonomy in three different old women groups after a 18 weeks 1) Pilates-based structured exercise program, 2) muscular structured exercise program, and 3) nonexercising.

Detailed Description
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Real life conditions require concurrent attention-demanding tasks, increasing the risk of falling and contributing to disability. Pilates-based exercise is proposed as a combined core and mental training program grounded on learning functionally effective postural sets and motor patterns, that will provide better results than a muscular exercise program in old women trunk strength, the risk of falling, functional autonomy and other complementary physical and mental functions. This is a 30-weeks quasi-experimental randomized controlled trial in which 80 independent old women will be allocated to a Pilates-based exercise program, a muscular exercise program, and a no-exercise control group. The intervention is divided into 18 weeks of supervised exercise and a 12 weeks follow-up. Primary outcome will be isokinetic and isometric trunk and hip flexion-extension strength, static and dynamic balance, the number of falls, and functional autonomy. Secondary outcome will include body composition, habitual physical activity and a standardized gerontological evaluation composed of body composition, daily physical activity, the independence to develop basic and instrumental activities of daily living, and the cognitive, affective and social function assessment. Every item will be measured at baseline, 18 and 30 weeks.

Official Title
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A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women: Study Protocol for a Randomized Controlled Trial

Conditions
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Healthy Aged Women

Intervention / Treatment
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* Other: Pilates exercise
* Other: Muscular exercise
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged from 60 to 80 years, physically and mentally able to enroll in the exercise programs. The level of education, toxic habits, medical treatment and/or diseases that can affect musculoskeletal or cardiovascular systems, mental illness, urinary incontinence, the presence of oedema and high blood pressure will be controlled. Exclusion Criteria: Current or prior participation in a structured Pilates-based or muscular exercise program in the past 3 months, and visual or auditory impairments not corrected with glasses or hearing aid. Each participant will also be at least 80% compliant to the exercise.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilates exercise program<br>Incorporate Pilates principles to stimulate core muscles in a dynamic and static way, and exercising arms and legs complementarity with balance as an essential part of standing exercises. | Other: Pilates exercise<br>* 2 sessions/week, 1 hour/session during 18 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES).<br>|
| Experimental: Muscular exercise program<br>To train core muscles in a dynamic and static way, and exercising arms and legs complementarity with balance as an essential part of standing exercises. | Other: Muscular exercise<br>* 2 sessions/week, 1 hour/session during 18 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES).<br>|
| Active Comparator: Control group<br>Healthy active but nonexercising old women | Other: Control Group<br>* No exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in trunk and hip isokinetic and isometric muscular flexion/extension peak torque, given in Newtons per meter. | assessed on a Biodex System III Pro Isokinetic Dynamometer (Biodex Medical System, NY, USA). | Changes from baseline at 18 weeks and Changes from baseline at 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in displacement of the center of pressure (millimeters) and time spent standing on two feet, tandem and monopodal display. | assessed with a portable force platform (Kistler, 9286AA). | Changes from baseline at 18 weeks and Changes from baseline at 30 weeks | 
| Changes in time spent to accomplish the Timed Up and Go test for dynamic balance | participants will be given instructions to stand up from a chair, walk 3 meters as quickly and safely as possible, turn around a cone, walk back and sit down. | Changes from baseline at 18 weeks and Changes from baseline at 30 weeks | 
| number of falls | number of falls registration | participants will be followed every 4 weeks | 
| Changes in time to accomplish the protocol GDLAM for assessing functional autonomy | protocol GDLAM consists of: 10 meters walking speed, standing up from a chair during 5 times, get up the floor from the ventral decubitus position, standing up from a chair and walk around a triangular circuit, and putting on and taking off a T-shirt. | Changes from baseline at 18 weeks and Changes from baseline at 30 weeks | 
| Changes in bone mineral, lean mass (nonbone), and fat mass for total body, head, chest, trunk, hip, right and left legs and arms regions. | assessed with a dual-energy X-ray bone densitometry (XR-46, Norland Corp., Fort Atkinson, USA). | Changes from baseline at 18 weeks and Changes from baseline at 30 weeks | 
| Changes in score from the Physical Activity Scale for the Elderly (PASE) to measure habitual physical activity. | The PASE is comprised of self-reported occupational, household and leisure items over a one-week period. | Changes from baseline at 18 weeks and Changes from baseline at 30 weeks | 
| Changes in the Katz scale index to assess the independence to develop basic activities of daily living | It summarizes performance in six functions: namely, bathing, dressing, going to toilet, transferring, continence and feeding. | Changes from baseline at 18 weeks and Changes from baseline at 30 weeks | 
| Changes in the Lawton and Brody's scale index to assess the independence to develop instrumental activities of daily living | It encomprises eight functional abilities, such as the use of the telephone, shopping, food preparation, housekeeping, laundry, mode of transport, taking medication and handling finances. | Changes from baseline at 22 weeks and Changes from baseline at 34 weeks | 
| Changes in the Mini-Mental State score to assess the cognitive function | It covers orientation, memory, attention, calculation, recall and language | Changes from baseline at 22 weeks and Changes from baseline at 34 weeks | 
| Changes in the Geriatric Depression Scale of Yesavage (GDSy) score to determine the affective function | It is composed of 15 questions that cover a wide variety of topics relevant to depression, such as somatic complaints, cognitive complaints, motivations, future/past orientation, self-image, losses, agitation, obsessive traits, and mood itself. | Changes from baseline at 22 weeks and Changes from baseline at 34 weeks |