NCT03526757

Brief Summary

Importance: Aging is characterized by numerous molecular, physiological, functional, motor and psychological changes, such as loss of postural balance and reduced muscle mass/strength. Such modifications often lead to reduced physical-functional capacity in the elderly and increased risk of falls. Currently, physical exercise is widely used to improve physical performance and reduce, at least in part, postural instabilities and the risk of falls. In this context, the Pilates method may be a good strategy to improve body balance, muscle strength and, potentially, the perception of quality of life in this population, depending how the exercises are performed. This study seeks to assess whether practicing Pilates exercises in orthostatic position results in differential effects on walking mobility and postural balance in healthy elderly women when compared to the standard sequence in the Pilates method, which involves less time performing exercise in the orthostatic position. The study hypothesis is that a higher relative volume of Pilates exercises performed in the orthostatic position can promote greater benefits in terms of walking mobility and postural balance compared to the standard Pilates protocol in the elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

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

March 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

September 21, 2021

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

April 26, 2018

Last Update Submit

September 14, 2021

Conditions

Keywords

Postural balancePilates methodElderly

Outcome Measures

Primary Outcomes (1)

  • Walking mobility (Timed Up and Go Test)

    Walking mobility will be assessed using the Timed Up and Go tests (single and dual task - cognitive/motor). It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.

    Post-intervention (change after 12 weeks of training)

Secondary Outcomes (4)

  • Postural balance - Functional Reach Test

    Post-intervention (change after 12 weeks of training)

  • Postural balance - BERG Balance scale

    Post-intervention (change after 12 weeks of training)

  • Activities-specific Balance Confidence (ABC) Scale.

    Post-intervention (change after 12 weeks of training)

  • Quality of life (36-Item Short Form Health Survey - SF-36)

    Post-intervention (change after 12 weeks of training)

Other Outcomes (3)

  • Physical Activity Levels

    Baseline

  • Cognition screening

    Baseline

  • Depression screening

    Baseline

Study Arms (2)

Standing Pilates protocol

EXPERIMENTAL

Subjects will be submitted to a bi-weekly, 50-minute session of Pilates exercises focusing on orthostatic position, for twelve weeks. The following equipment will be used: The Cadillac, Reformer and Chair, emphasizing balance training in the orthostatic position.

Other: Standing Pilates protocol

Standard Pilates protocol

ACTIVE COMPARATOR

Subjects will be submitted to a bi-weekly, 50-minute session of the standard sequence of Pilates exercises (traditional sequence of the contemporary / classical method) for twelve weeks. The exercises will be performed using the same equipment used in the intervention group, but following the dorsal decubitus, sedestation and orthostasis, in a time-balanced distribution in each session.

Other: Standard Pilates protocol

Interventions

Subjects will be submitted to a bi-weekly, 50-minute session of Pilates exercises focusing on orthostatic position, for twelve weeks. The following equipment will be used: The Cadillac, Reformer and Chair, emphasizing balance training in the orthostatic position.

Also known as: Pilates exercises in orthostatic position
Standing Pilates protocol

Subjects will be submitted to a bi-weekly, 50-minute session of the standard sequence of Pilates exercises (traditional sequence of the contemporary / classical method) for twelve weeks. The exercises will be performed using the same equipment used in the intervention group, but following the dorsal decubitus, sedestation and orthostasis, in a time-balanced distribution in each session.

Also known as: Standard Pilates exercises
Standard Pilates protocol

Eligibility Criteria

Age60 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study seeks to investigate elderly women, since they show higher risk of falling.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary for at least 6 months
  • To be available for one hour, twice a week, on two different working days to perform the proposed exercises.
  • To show preserved cognitive function, according to the mini-mental state examination criteria;
  • Be able to come and go on their own to the training location (Physiotherapy Laboratory at PUCRS).

You may not qualify if:

  • Clinical contraindications for performing physical exercises;
  • To show severe heart, orthopedic, neurological or other diseases/conditions that may affect the outcome measures;
  • Practicing physical exercises outside the study protocol;
  • Absence of independent gait.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90619-900, Brazil

Location

Related Publications (8)

  • Bird ML, Hill KD, Fell JW. A randomized controlled study investigating static and dynamic balance in older adults after training with Pilates. Arch Phys Med Rehabil. 2012 Jan;93(1):43-9. doi: 10.1016/j.apmr.2011.08.005. Epub 2011 Oct 5.

    PMID: 21975148BACKGROUND
  • Walowska J, Bolach B, Bolach E. The influence of Pilates exercises on body balance in the standing position of hearing impaired people. Disabil Rehabil. 2018 Dec;40(25):3061-3069. doi: 10.1080/09638288.2017.1370731. Epub 2017 Nov 13.

    PMID: 29132250BACKGROUND
  • Bueno de Souza RO, Marcon LF, Arruda ASF, Pontes Junior FL, Melo RC. Effects of Mat Pilates on Physical Functional Performance of Older Adults: A Meta-analysis of Randomized Controlled Trials. Am J Phys Med Rehabil. 2018 Jun;97(6):414-425. doi: 10.1097/PHM.0000000000000883.

    PMID: 29283899BACKGROUND
  • Oliveira LC, Oliveira RG, Pires-Oliveira DAA. Pilates increases the isokinetic muscular strength of the knee extensors and flexors in elderly women. J Bodyw Mov Ther. 2017 Oct;21(4):815-822. doi: 10.1016/j.jbmt.2017.01.006. Epub 2017 Jan 8.

    PMID: 29037633BACKGROUND
  • Bertoli J, Biduski GM, de la Rocha Freitas C. Six weeks of Mat Pilates training are enough to improve functional capacity in elderly women. J Bodyw Mov Ther. 2017 Oct;21(4):1003-1008. doi: 10.1016/j.jbmt.2016.12.001. Epub 2016 Dec 3.

    PMID: 29037615BACKGROUND
  • Teixeira de Carvalho F, de Andrade Mesquita LS, Pereira R, Neto OP, Amaro Zangaro R. Pilates and Proprioceptive Neuromuscular Facilitation Methods Induce Similar Strength Gains but Different Neuromuscular Adaptations in Elderly Women. Exp Aging Res. 2017 Oct-Dec;43(5):440-452. doi: 10.1080/0361073X.2017.1369624. Epub 2017 Sep 26.

    PMID: 28949820BACKGROUND
  • Vieira ND, Testa D, Ruas PC, Salvini TF, Catai AM, de Melo RC. The effects of 12 weeks Pilates-inspired exercise training on functional performance in older women: A randomized clinical trial. J Bodyw Mov Ther. 2017 Apr;21(2):251-258. doi: 10.1016/j.jbmt.2016.06.010. Epub 2016 Jun 21.

    PMID: 28532866BACKGROUND
  • Greblo Jurakic Z, Krizanic V, Sarabon N, Markovic G. Effects of feedback-based balance and core resistance training vs. Pilates training on cognitive functions in older women with mild cognitive impairment: a pilot randomized controlled trial. Aging Clin Exp Res. 2017 Dec;29(6):1295-1298. doi: 10.1007/s40520-017-0740-9. Epub 2017 Mar 1.

    PMID: 28251569BACKGROUND

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Régis G Mestriner, PhD

    Pontifícia Universidade Católica do Rio Grande do Sul

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors are masked for subject allocation.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: The subjects will be allocated to one of two groups: intervention protocol (high volume of standing Pilates exercises) or control protocol (standard sequence of Pilates exercises).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 16, 2018

Study Start

March 1, 2018

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

September 21, 2021

Record last verified: 2019-07

Locations