Back to resultsEffectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Strengthening and balance exercises
Stretching and balance exercises
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring elderly, postural balance, musculoskeletal equilibrium, posture, muscle strength, muscle stretching exercises
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- University of Sao Paulo General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Strengthening Group
Stretching Group
Control Group
Arm Description
Performed balance training with lower limbs muscle strengthening.
Performed balance training with stretching
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Postural alignment
Postual alignment (thoracic kyphosis and forward head) measured by PAS/SAPO (Postural Assessment Software)
Lower limb muscle strength
The muscle strength in knee extension and knee flexion was evaluated by dynamometry.
Shortening of the hamstrings
The shortening of the hamstrings was evaluated by goniometry.
Berg Balance Scale
Full Information
NCT ID
NCT01210469
First Posted
September 27, 2010
Last Updated
October 5, 2010
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01210469
Brief Title
Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis
Official Title
Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The decrease in postural control and muscle strength in lower limbs have been identified as major risk factors for falls in older people. Exercises have proven effective in decreasing risk factors in healthy elderly, but little is known about the effects of interventions with exercise in the elderly with osteoporosis.
Objective: To 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.
Methods: Fifty elderly aged 65 or older, with a diagnosis of osteoporosis, were randomized into 3 groups: Strength Group (n = 17) performed balance training with muscle strengthening; Stretching Group (n = 17) performed balance training with stretching; and Control Group (n =16) did not do activity. The groups trained for 8 weeks, with sessions of about 60 minutes, twice a week. 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, the functional balance by Berg Balance Scale (BBS), muscle strength by dynamometry, the shortening of the hamstrings by goniometry and posture by PAS/SAPO (Postural Assessment Software).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
elderly, postural balance, musculoskeletal equilibrium, posture, muscle strength, muscle stretching exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strengthening Group
Arm Type
Experimental
Arm Description
Performed balance training with lower limbs muscle strengthening.
Arm Title
Stretching Group
Arm Type
Experimental
Arm Description
Performed balance training with stretching
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Strengthening and balance exercises
Other Intervention Name(s)
Force Platform, Balance Master
Intervention Description
The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
Intervention Type
Other
Intervention Name(s)
Stretching and balance exercises
Other Intervention Name(s)
Force Platform, Balance Master
Intervention Description
The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
Primary Outcome Measure Information:
Title
Postural Control
Description
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
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
Postural alignment
Description
Postual alignment (thoracic kyphosis and forward head) measured by PAS/SAPO (Postural Assessment Software)
Time Frame
eight weeks
Title
Lower limb muscle strength
Description
The muscle strength in knee extension and knee flexion was evaluated by dynamometry.
Time Frame
eight weeks
Title
Shortening of the hamstrings
Description
The shortening of the hamstrings was evaluated by goniometry.
Time Frame
eight weeks
Title
Berg Balance Scale
Time Frame
Eight weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomaz N Burke, MSc
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
São Paulo
Country
Brazil
12. IPD Sharing Statement
Links:
URL
http://www.teses.usp.br/teses/disponiveis/5/5163/tde-08032010-162215/
Description
Link to my thesis in portuguese
Learn more about this trial
Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis
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