NCT01210469

Brief Summary

The purpose of this study was compare the efficacy of two exercise programs - the first consisting of balance training and muscle strength and the second consisting of balance training and muscle stretching exercises - to improve postural control in elderly women with osteoporosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

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

Study Start

First participant enrolled

July 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
Last Updated

October 6, 2010

Status Verified

March 1, 2008

Enrollment Period

1.9 years

First QC Date

September 27, 2010

Last Update Submit

October 5, 2010

Conditions

Keywords

elderlypostural balancemusculoskeletal equilibriumposturemuscle strengthmuscle stretching exercises

Outcome Measures

Primary Outcomes (1)

  • Postural Control

    Postural control was evaluated by Modified Clinical Test of Sensory Interaction for Balance (CTSIBm) and Limits of Stability test (LOS) in Balance Master force plate

    eight weeks

Secondary Outcomes (4)

  • Postural alignment

    eight weeks

  • Lower limb muscle strength

    eight weeks

  • Shortening of the hamstrings

    eight weeks

  • Berg Balance Scale

    Eight weeks

Study Arms (3)

Strengthening Group

EXPERIMENTAL

Performed balance training with lower limbs muscle strengthening.

Other: Strengthening and balance exercises

Stretching Group

EXPERIMENTAL

Performed balance training with stretching

Other: Stretching and balance exercises

Control Group

NO INTERVENTION

Interventions

The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.

Also known as: Force Platform, Balance Master
Strengthening Group

The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.

Also known as: Force Platform, Balance Master
Stretching Group

Eligibility Criteria

Age65 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • women from 65 to 80 yrs of age
  • diagnosis of osteoporosis classified according to the criteria of the World Health Organization, with bone mineral densitometry reduced by at least 2.5 SD when compared with young adults (region of lumbar spine)

You may not qualify if:

  • severe visual deficiency
  • physically incapable of participating in the tests
  • neurological disorders, amputations, or prostheses
  • individuals with regular physical activity (twice or more per week) or who had recently participated in exercise programs for muscular strength or balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

Related Links

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Thomaz N Burke, MSc

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 27, 2010

First Posted

September 28, 2010

Study Start

July 1, 2007

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

October 6, 2010

Record last verified: 2008-03

Locations