OsteoporosisNCT01210469
Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis
A study testing Strengthening and balance exercises and Stretching and balance exercises in people with Osteoporosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Strengthening and balance exercises and Stretching and balance exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis: a Randomized Clinical Trial
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.
Read the 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).
- Conditions
- Osteoporosis
- Being tested
- Strengthening and balance exercises, Stretching and balance exercises
- Keywords
- elderly, postural balance, musculoskeletal equilibrium, posture, muscle strength, muscle stretching exercises
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening and balance exercisesOther
Also called Force Platform, Balance Master
The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
Stretching and balance exercisesOther
Also called Force Platform, Balance Master
The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Strengthening Group | Experimental | Performed balance training with lower limbs muscle strengthening. Receives: Other: Strengthening and balance exercises |
| Stretching Group | Experimental | Performed balance training with stretching Receives: Other: Stretching and balance exercises |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: eight weeks
Secondary outcomes (4)
Postural alignment
Postual alignment (thoracic kyphosis and forward head) measured by PAS/SAPO (Postural Assessment Software)
Measured: eight weeks
Lower limb muscle strength
The muscle strength in knee extension and knee flexion was evaluated by dynamometry.
Measured: eight weeks
Shortening of the hamstrings
The shortening of the hamstrings was evaluated by goniometry.
Measured: eight weeks
Berg Balance Scale
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startJul 2007
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Thomaz N Burke, MSc, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210469
- Sponsor's protocol ID
- 787/06
- Status last verified
- Mar 2008
- First submitted
- 27 Sep 2010
- Last updated
- 6 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Treatments on Posture and Balance in Elderly Women With Osteoporosis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01210469
- Acronym / sponsor ID
- 787/06
- Conditions
- Osteoporosis
- Keywords
- elderly, postural balance, musculoskeletal equilibrium, posture, muscle strength, muscle stretching exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Strengthening Group | Experimental | Other: Strengthening and balance exercisesPerformed balance training with lower limbs muscle strengthening. |
| Stretching Group | Experimental | Other: Stretching and balance exercisesPerformed balance training with stretching |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthening and balance exercisesAlso: Force Platform, Balance MasterThe group trained for 8 weeks, with sessions of about 60 minutes, twice a week. | Other | Strengthening Group |
| Stretching and balance exercisesAlso: Force Platform, Balance MasterThe group trained for 8 weeks, with sessions of about 60 minutes, twice a week. | Other | Stretching Group |
Primary outcome
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
4 secondary outcomes
Postural alignment
Time frame: eight weeks
Lower limb muscle strength
Time frame: eight weeks
Shortening of the hamstrings
Time frame: eight weeks
Berg Balance Scale
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2010.
- Link to my thesis in portugueseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomaz N Burke, MSc principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening and balance exercises and Stretching and balance exercises in people with Osteoporosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Control (time frame: eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2010.