- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01210469
Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis
Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis: a Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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São Paulo, Brazil
- University of Sao Paulo General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
|
Experimental: Strengthening Group
Performed balance training with lower limbs muscle strengthening.
|
The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
Other Names:
|
|
Experimental: Stretching Group
Performed balance training with stretching
|
The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Control
Time Frame: eight weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural alignment
Time Frame: eight weeks
|
Postual alignment (thoracic kyphosis and forward head) measured by PAS/SAPO (Postural Assessment Software)
|
eight weeks
|
|
Lower limb muscle strength
Time Frame: eight weeks
|
The muscle strength in knee extension and knee flexion was evaluated by dynamometry.
|
eight weeks
|
|
Shortening of the hamstrings
Time Frame: eight weeks
|
The shortening of the hamstrings was evaluated by goniometry.
|
eight weeks
|
|
Berg Balance Scale
Time Frame: Eight weeks
|
Eight weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Thomaz N Burke, MSc, University of Sao Paulo
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 787/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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