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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02506491
Enrollment
60
Registered
2015-07-23
Start date
2014-09-30
Completion date
2016-12-31
Last updated
2018-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Aged Women

Brief summary

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

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.

Interventions

OTHERPilates exercise

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).

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).

OTHERControl Group

No exercise

Sponsors

Hospital Universitario Virgen de la Arrixaca
CollaboratorOTHER
Universidad Católica San Antonio de Murcia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
60 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in trunk and hip isokinetic and isometric muscular flexion/extension peak torque, given in Newtons per meter.Changes from baseline at 18 weeks and Changes from baseline at 30 weeksassessed on a Biodex System III Pro Isokinetic Dynamometer (Biodex Medical System, NY, USA).

Secondary

MeasureTime frameDescription
Changes in time spent to accomplish the Timed Up and Go test for dynamic balanceChanges from baseline at 18 weeks and Changes from baseline at 30 weeksparticipants 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.
number of fallsparticipants will be followed every 4 weeksnumber of falls registration
Changes in time to accomplish the protocol GDLAM for assessing functional autonomyChanges from baseline at 18 weeks and Changes from baseline at 30 weeksprotocol 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 in bone mineral, lean mass (nonbone), and fat mass for total body, head, chest, trunk, hip, right and left legs and arms regions.Changes from baseline at 18 weeks and Changes from baseline at 30 weeksassessed with a dual-energy X-ray bone densitometry (XR-46, Norland Corp., Fort Atkinson, USA).
Changes in displacement of the center of pressure (millimeters) and time spent standing on two feet, tandem and monopodal display.Changes from baseline at 18 weeks and Changes from baseline at 30 weeksassessed with a portable force platform (Kistler, 9286AA).
Changes in the Katz scale index to assess the independence to develop basic activities of daily livingChanges from baseline at 18 weeks and Changes from baseline at 30 weeksIt summarizes performance in six functions: namely, bathing, dressing, going to toilet, transferring, continence and feeding.
Changes in the Lawton and Brody's scale index to assess the independence to develop instrumental activities of daily livingChanges from baseline at 22 weeks and Changes from baseline at 34 weeksIt 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 in the Mini-Mental State score to assess the cognitive functionChanges from baseline at 22 weeks and Changes from baseline at 34 weeksIt covers orientation, memory, attention, calculation, recall and language
Changes in the Geriatric Depression Scale of Yesavage (GDSy) score to determine the affective functionChanges from baseline at 22 weeks and Changes from baseline at 34 weeksIt 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 in score from the Physical Activity Scale for the Elderly (PASE) to measure habitual physical activity.Changes from baseline at 18 weeks and Changes from baseline at 30 weeksThe PASE is comprised of self-reported occupational, household and leisure items over a one-week period.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026