Clinical trial NCT02506491: A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women
Official title: A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aged Women
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen de la Arrixaca
First posted: 2015-07-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in trunk and hip isokinetic and isometric muscular flexion/extension peak torque, given in Newtons per meter.
timeFrame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
Secondary outcomes:
measure: Changes in displacement of the center of pressure (millimeters) and time spent standing on two feet, tandem and monopodal display.
timeFrame: Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
measure: Changes in time spent to accomplish the Timed Up and Go test for dynamic balance
timeFrame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
measure: number of falls
timeFrame: participants will be followed every 4 weeks
measure: Changes in time to accomplish the protocol GDLAM for assessing functional autonomy
timeFrame: Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks
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.
timeFrame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
measure: Changes in score from the Physical Activity Scale for the Elderly (PASE) to measure habitual physical activity.
timeFrame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
measure: Changes in the Katz scale index to assess the independence to develop basic activities of daily living
timeFrame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
measure: Changes in the Lawton and Brody's scale index to assess the independence to develop instrumental activities of daily living
timeFrame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
measure: Changes in the Mini-Mental State score to assess the cognitive function
timeFrame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
measure: Changes in the Geriatric Depression Scale of Yesavage (GDSy) score to determine the affective function
timeFrame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
Other outcomes:
Locations:
Study officials:
affiliation: Universidad de Almeria
name: Maria Carrasco, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Católica San Antonio. Murcia
name: Domingo J Ramos-Campo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Católica San Antonio. Murcia
name: Jacobo A Rubio-Arias, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Católica San Antonio. Murcia
name: Delia Reche-Orenes, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carrasco M, Martínez I, Vaquero M. Cambios en la fuerza isométrica de las mujeres postmenopáusicas tras el ejercicio en el medio acuático. Revista Internacional de Medicina y Ciencias de la Actividad Física y el deporte 13(49): 73-85, 2013
citation: Zaragoza AB, Carrasco M. Condición Física y estado de salud mental en mujeres mayores físicamente independientes. European Journal of Investigation in Health, Psychology and Education. 4(3): 289-300, 2014.
citation: Carrasco M, Vaquero M. Training in a shallow pool: Its effect on upper extremity strength and total body weight in postmenopausal women. International SportMed Journal 12(1): 17-29, 2011
citation: Carrasco M, Vaquero M. Water training in postmenopausal women: effect on muscular strength. European Journal of Sport Science 12(2): 193-200, 2011
citation: Carrasco M, Reche D, Torres-Sobejano M, Romero E, Martínez I. Comparación de la movilidad del raquis entre mujeres de mediana edad practicantes de pilates y de otro tipo de ejercicio. Journal of Sport and Health Research 6(2): 169-176, 2014
citation: González-Galvez N, Carrasco M, Marcos-Pardo PJ, Feito Y. The effect of Pilates Method in scholar's trunk strength and hamstring flexibility. Gender differences. International Journal of Medical, Health, Pharmaceutical and Biomedical Engineerin 8(6): 348-351, 2014.
citation: Carrasco M, Martínez I, Navarro MD. Daily physical activity and bone mineral density in older women. Revista Brasileira de Medicina do Esporte 21(1): 22-26, 2015.
citation: Carrasco-Poyatos M, Ramos-Campo DJ, Rubio-Arias JA. Pilates versus resistance training on trunk strength and balance adaptations in older women: a randomized controlled trial. PeerJ. 2019 Nov 14;7:e7948. doi: 10.7717/peerj.7948. eCollection 2019.
citation: Carrasco-Poyatos M, Rubio-Arias JA, Ballesta-Garcia I, Ramos-Campo DJ. Pilates vs. muscular training in older women. Effects in functional factors and the cognitive interaction: A randomized controlled trial. Physiol Behav. 2019 Mar 15;201:157-164. doi: 10.1016/j.physbeh.2018.12.008. Epub 2018 Dec 8.