NCT01379235

Brief Summary

Background: The elderly population in western countries and in Israel is constantly growing. Falls are one of the common problems among this population. Thus there is a need for falls prevention exercise program to be offered in the different settings elderly reside. Most methods for physical exercise are dedicated to muscle strengthening and improving balance by strengthening external muscles. Pilatis exercise program focuses mainly on strengthening the in-depth muscles. The advantage of this method is in its simplicity and availability. This method is suitable also for special populations as patients in acute hospitalization. In this study, the investigators will evaluate if the pilatis exercise can improve balance of elderly population. Physical exercise usually improves the mood. Like any physical exercise, Pilatis exercise has a mental advantage, therefore, this study will also examine if pilatis exercise can improve quality of life of elderly population. Working hypothesis and aims: Pilatis exercise will improve balance and stability measurements, and quality of life among elderly population. Methods: Randomized, prospective study among elderly patients aged 65 and above belonging to Clalit Health Services primary care clinic . Participants of the intervention and control group will receive a brochure that will include nutrition and healthy life style recommendations. Intervention group: will receive 12 weeks of pilatis exercise 3 times a week. The control group will be offered the same intervention at the end of the study period. Balance evaluation will be performed using the: Tinetti Balance Gait Scale, Berg Balance Scale, Multidirectional Reach Test, Timed Up and Go, Step execution test. The SF-36 questionnaire will be use to evaluate quality of life. Importance: This study will examine the influence of pilatis exercise on balance among the elderly. If findings will determine that pilatis does improve balance in the elderly, the investigators can further examine pilatis's influence on falls prevention, and minimizing falls damages. Probable implications to the welfare and health of the aged population: Improving balance, falls preventing and minimizing falls damages among elderly; improvement in elderly quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started Jan 2012

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 19, 2014

Status Verified

June 1, 2012

Enrollment Period

9 months

First QC Date

February 15, 2011

Last Update Submit

November 18, 2014

Conditions

Keywords

independent 65 years old and above

Outcome Measures

Primary Outcomes (1)

  • postural stability test

    Statistically significance difference in postural stability test will be found when comparing pre and post intervention results in the intervention group of the Step execution test. This outcome is a combination of the variables: elliptical area(mm2), sway velocity (mm/s), mediolateral sway (mm)and anterior posterior sway (mm).

    3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group: will receive 12 weeks of pilatis exercise 3 times a week.

Other: Pilatis exercise

control group

OTHER

The control group will be offered the same intervention (pilatis exercise) at the end of the study period.

Other: Pilatis exercise

Interventions

12 weeks of pilatis exercise 3 times a week.

Intervention groupcontrol group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Man and Women aged 65 years old and above
  • Able to walk independently without devices (cane is exceptable)

You may not qualify if:

  • Unstable diseases (unstable angina; heart failure- NIHA 3 or 4; lung disease with shortness of breath on light effort; end stage liver and kidney diseases; terminal malignant diseases)
  • MMSE less then 24
  • After hip or knee surgery
  • After lower limb amputation
  • Neurological diseases with significant gait and balance instability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services (HMO)

Beersheba, Israel

Location

Study Officials

  • Yan Press, MD

    Ben-Gurion University of the Negev

    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
SPONSOR

Study Record Dates

First Submitted

February 15, 2011

First Posted

June 23, 2011

Study Start

January 1, 2012

Primary Completion

October 1, 2012

Study Completion

July 1, 2013

Last Updated

November 19, 2014

Record last verified: 2012-06

Locations