OsteoporosisNCT00227071
Aquatic Verses Land Exercise to Decrease Fall Risk
A study testing exercise in people with Osteoporosis, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Compare the effect of aquatic,land and no exercise on fall risk factors in women diagnosed with osteoporosis Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 73 participants
- Where
- 1 siteCanada
- Study dates
- Sep 1999to Jun 2002
- 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 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 60 or older
- diagnosed with osteoporosis
- female
Who cannot join
- has not been involved in regular exercise in past 2 months
- does not have any medical or neurological condition that would significantly limit activities of daily living, such that involvement in an exercise program would jeopardize safety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Water Verses Land Exercise to Decrease Fall Risk in Older Women With Osteoporosis
Compare the effect of aquatic,land and no exercise on fall risk factors in women diagnosed with osteoporosis
Read the detailed description
Background and Purpose: Fall prevention through exercise is an ongoing goal of researchers and clinicians. This study compared the effects of aquatic exercise (AE), land exercise (LE) and no exercise (NE) on fall risk factors. Subjects: Seventy-three women, 60 or older, with osteoporosis (OP). Method: Randomized clinical trial comparing balance, posture, strength, mobility, function, falls, and quality of life. Results: Significant differences (p<0.05) were found for participants' ratings of global change (AE and LE > NE), tandem balance (AE > LE) and function (LE > AE). Joint pain and falls occurred more often during LE. Discussion and Conclusion: Participants experienced significant global improvement with both AE and LE. Less joint pain, reduced falls and improved balance were found in AE, however LE was more effective in improving functional ability at home. Clinicians should consider the individual's specific impairments and risk factors when recommending exercise programs on land or in water.
- Conditions
- Osteoporosis
- Being tested
- exercise
- Keywords
- accidental falls, osteoporosis, risk factors
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
balance
mobility
function
quality of life
Secondary outcomes (1)
bone status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startSep 1999
- Study completionJun 2002
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.
- 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
- Crossover
- Masking
- Single blind
- Enrolment
- 73 participants
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Investigators
- Cathy M Arnold, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227071
- Sponsor's protocol ID
- BMC 1999-65
- Status last verified
- Sep 2005
- First submitted
- 23 Sep 2005
- Last updated
- 4 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Water Verses Land Exercise to Decrease Fall Risk in Older Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT00227071
- Acronym / sponsor ID
- BMC 1999-65
- Conditions
- Osteoporosis
- Keywords
- accidental falls, osteoporosis, risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatchewan Health Research Foundation
- Study start
- Sep 1999
- Study completion
- Jun 2002
- First posted
- 27 Sep 2005 (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.
Compare the effect of aquatic,land and no exercise on fall risk factors in women diagnosed with osteoporosis
Detailed description
Background and Purpose: Fall prevention through exercise is an ongoing goal of researchers and clinicians. This study compared the effects of aquatic exercise (AE), land exercise (LE) and no exercise (NE) on fall risk factors. Subjects: Seventy-three women, 60 or older, with osteoporosis (OP). Method: Randomized clinical trial comparing balance, posture, strength, mobility, function, falls, and quality of life. Results: Significant differences (p<0.05) were found for participants' ratings of global change (AE and LE > NE), tandem balance (AE > LE) and function (LE > AE). Joint pain and falls occurred more often during LE. Discussion and Conclusion: Participants experienced significant global improvement with both AE and LE. Less joint pain, reduced falls and improved balance were found in AE, however LE was more effective in improving functional ability at home. Clinicians should consider the individual's specific impairments and risk factors when recommending exercise programs on land or in water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 60 or older
- diagnosed with osteoporosis
- female
Key exclusion criteria (2 listed)
- has not been involved in regular exercise in past 2 months
- does not have any medical or neurological condition that would significantly limit activities of daily living, such that involvement in an exercise program would jeopardize safety
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 |
|---|---|---|
| exercise | Behavioural | – |
Primary outcome
muscle strength
balance
mobility
function
quality of life
1 secondary outcome
bone status
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 4 Jan 2006.
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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.
Cathy M Arnold principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Osteoporosis, run by University of Saskatchewan at 1 site in Canada.
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 3 inclusion and 2 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 4 Jan 2006. 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 Canada. 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?
muscle strength. The study lists 5 primary outcomes in all. 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 4 Jan 2006.