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Completed

NCT Number: NCT02506491

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

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.

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Key information

Conditions

Healthy Aged Women

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pilates exercise

Other

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).

Muscular exercise

Other

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).

Control Group

Other

No exercise

Primary outcomes

  1. Changes in trunk and hip isokinetic and isometric muscular flexion/extension peak torque, given in Newtons per meter.

    Time frame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"

    assessed on a Biodex System III Pro Isokinetic Dynamometer (Biodex Medical System, NY, USA).

Secondary outcomes

  1. Changes in displacement of the center of pressure (millimeters) and time spent standing on two feet, tandem and monopodal display.

    Time frame: Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"

    assessed with a portable force platform (Kistler, 9286AA).

  2. Changes in time spent to accomplish the Timed Up and Go test for dynamic balance

    Time frame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"

    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.

  3. number of falls

    Time frame: participants will be followed every 4 weeks

    number of falls registration

  4. Changes in time to accomplish the protocol GDLAM for assessing functional autonomy

    Time frame: Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks

    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.

  5. Changes in bone mineral, lean mass (nonbone), and fat mass for total body, head, chest, trunk, hip, right and left legs and arms regions.

    Time frame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"

    assessed with a dual-energy X-ray bone densitometry (XR-46, Norland Corp., Fort Atkinson, USA).

  6. Changes in score from the Physical Activity Scale for the Elderly (PASE) to measure habitual physical activity.

    Time frame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"

    The PASE is comprised of self-reported occupational, household and leisure items over a one-week period.

  7. Changes in the Katz scale index to assess the independence to develop basic activities of daily living

    Time frame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"

    It summarizes performance in six functions: namely, bathing, dressing, going to toilet, transferring, continence and feeding.

  8. Changes in the Lawton and Brody's scale index to assess the independence to develop instrumental activities of daily living

    Time frame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"

    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.

  9. Changes in the Mini-Mental State score to assess the cognitive function

    Time frame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"

    It covers orientation, memory, attention, calculation, recall and language

  10. Changes in the Geriatric Depression Scale of Yesavage (GDSy) score to determine the affective function

    Time frame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"

    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.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Collaborators

  • Hospital Universitario Virgen de la Arrixaca

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 23, 2015
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.