Overview

This trial is active, not recruiting.

Condition healthy aged women
Treatments pilates exercise, muscular exercise, control group
Sponsor Universidad Católica San Antonio de Murcia
Collaborator Hospital Universitario Virgen de la Arrixaca
Start date September 2014
End date December 2015
Trial size 80 participants
Trial identifier NCT02506491, PMAFI/24/14

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 22 weeks 1) Pilates-based structured exercise program, 2) muscular structured exercise program, and 3) nonexercising.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
pilates exercise
2 sessions/week, 1 hour/session during 22 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES).
(Experimental)
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.
muscular exercise
2 sessions/week, 1 hour/session during 22 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES).
(Active Comparator)
Healthy active but nonexercising old women
control group
No exercise

Primary Outcomes

Measure
Changes in trunk and hip isokinetic and isometric muscular flexion/extension peak torque, given in Newtons per meter.
time frame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
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 22 weeks" and "Changes from baseline at 34 weeks"
Changes in time spent to accomplish the Timed Up and Go test for dynamic balance
time frame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
number of falls
time frame: participants will be followed every 4 weeks
Changes in time to accomplish the protocol GDLAM for assessing functional autonomy
time frame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"

Secondary Outcomes

Measure
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 22 weeks" and "Changes from baseline at 34 weeks"
Changes in score from the Physical Activity Scale for the Elderly (PASE) to measure habitual physical activity.
time frame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
Changes in the Katz scale index to assess the independence to develop basic activities of daily living
time frame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
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"
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"
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"

Eligibility Criteria

Female participants from 60 years up to 80 years old.

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.

Additional Information

Official title A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women: Study Protocol for a Randomized Controlled Trial
Principal investigator Domingo J Ramos-Campo, PhD
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 34-weeks cluster 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 22 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, 22 and 34 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Universidad Católica San Antonio de Murcia.