- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02506491
A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women
July 2, 2018 updated by: Maria Carrasco, Universidad Católica San Antonio de Murcia
A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women: Study Protocol for a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pilates exercise program
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.
|
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).
|
Experimental: Muscular exercise program
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.
|
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).
|
Active Comparator: Control group
Healthy active but nonexercising old women
|
No exercise
|
What is the study measuring?
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.
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).
|
"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.
Time Frame: Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
|
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
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.
|
"Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
|
number of falls
Time Frame: participants will be followed every 4 weeks
|
number of falls registration
|
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 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.
|
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.
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).
|
"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.
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.
|
"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
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.
|
"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
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.
|
"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"
|
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
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.
|
"Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Maria Carrasco, PhD, Universidad de Almeria
- Principal Investigator: Domingo J Ramos-Campo, PhD, Universidad Católica San Antonio. Murcia
- Principal Investigator: Jacobo A Rubio-Arias, PhD, Universidad Católica San Antonio. Murcia
- Principal Investigator: Delia Reche-Orenes, PhD student, Universidad Católica San Antonio. Murcia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
- 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.
- 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
- Carrasco M, Vaquero M. Water training in postmenopausal women: effect on muscular strength. European Journal of Sport Science 12(2): 193-200, 2011
- 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
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
July 21, 2015
First Submitted That Met QC Criteria
July 22, 2015
First Posted (Estimate)
July 23, 2015
Study Record Updates
Last Update Posted (Actual)
July 5, 2018
Last Update Submitted That Met QC Criteria
July 2, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- PMAFI/24/14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Aged Women
-
Charite University, Berlin, GermanyCompleted
-
Near East University, TurkeyCompletedHealthy Postmenopausal Women | Serum CNP Levels | Healthy Reproductive Age Women | Healthy Perimenopausal WomenCyprus
-
Samsung Medical CenterGangnam Community Health Center; Gangnam-gu Center for DementiaUnknown
-
University of Kansas Medical CenterNational Dairy CouncilCompleted
-
Gerontopôle des Pays de la LoireUniversity Hospital, AngersCompletedHealthy | Aged (80 or More)France
-
University of PittsburghBill and Melinda Gates FoundationCompleted
-
Aziende Chimiche Riunite Angelini Francesco S.p.ACross Research S.A.CompletedHealthy WomenSwitzerland
-
University Hospital, Clermont-FerrandInstitut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement and other collaboratorsCompletedHealthy Volunteers (Middle-aged Smokers)France
-
Celal Bayar UniversityCompleted
-
Rennes University HospitalCompleted
Clinical Trials on Pilates exercise
-
Universidad de AntioquiaCompletedHealthy VolunteersColombia
-
Gazi UniversityUnknownRheumatoid ArthritisTurkey
-
Saglik Bilimleri UniversitesiCompleted
-
National University of Ireland, Galway, IrelandCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.Completed
-
Universidade Federal de Santa MariaCompleted
-
Eastern Mediterranean UniversityCompleted
-
Paulista UniversityCompleted
-
Istanbul Medipol University HospitalCompleted
-
Suleyman Demirel UniversityEnrolling by invitationBody Weight Changes | ExerciseTurkey
-
Eastern Mediterranean UniversityUnknownThe Effect of Exercise Training on Balance and Functional Status in Individuals With Osteoarthritis'Osteo Arthritis Knee | BalanceCyprus