NCT02506491

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

July 21, 2015

Last Update Submit

July 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (10)

  • 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 weeks"

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

    "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"

  • number of falls

    participants will be followed every 4 weeks

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

    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.

    "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"

  • +5 more secondary outcomes

Study Arms (3)

Pilates exercise program

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.

Other: Pilates exercise

Muscular exercise program

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.

Other: Muscular exercise

Control group

ACTIVE COMPARATOR

Healthy active but nonexercising old women

Other: Control Group

Interventions

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).

Pilates exercise program

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 program

No exercise

Control group

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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

    RESULT
  • 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.

    RESULT
  • 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

    RESULT
  • Carrasco M, Vaquero M. Water training in postmenopausal women: effect on muscular strength. European Journal of Sport Science 12(2): 193-200, 2011

    RESULT
  • 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

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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.

MeSH Terms

Interventions

Exercise Movement TechniquesControl Groups

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Maria Carrasco, PhD

    Universidad de Almeria

    STUDY DIRECTOR
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 21, 2015

First Posted

July 23, 2015

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

July 5, 2018

Record last verified: 2018-07