ArthritisPhase 1NCT00289458
Aquatic Exercise and Efficacy Enhancement to Decrease Fall Risk in Older Adults With Hip Osteoarthritis
A Phase 1 study testing exercise and 2 in people with Arthritis, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The objective of this project is to determine the effect of aquatic exercise and aquatic exercise combined with an education program on decreasing fall risk in older adults with hip osteoarthritis. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- exercise and 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2005to Apr 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- over age 65
- clinical diagnosis of hip osteoarthritis
Who cannot join
- medical condition tha significantly decreases functional ability such that not safe to exercise in a community program
- already exercising in a moderate exercise program 2/week or more
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Aquatic Exercise and Aquatic Exercise Combined With Education and Efficacy Enhancement on Improving Indices of Fall Risk in Older Adults With Hip Osteoarthritis: a Randomized Controlled Clinical Trial
The objective of this project is to determine the effect of aquatic exercise and aquatic exercise combined with an education program on decreasing fall risk in older adults with hip osteoarthritis. The hypothesis is that aquatic exercise will improve function, strength and balance and the addition of the education session will enhance confidence in movement.
Read the detailed description
Older adults with hip osteoarthritis (OA) often experience pain and loss of mobility that significantly impairs their ability to walk, climb stairs, shop or participate in exercise programs. This can result in social isolation, depression and loss of confidence in their ability to manage independently in the community. A decline in physical and psycho-social function leads to increased risk of falling. It is crucial to identify high-risk fallers as well as the best interventions to decrease that risk; hip fractures from falls are devastating, resulting in death or admission to long-term care for the majority who sustain them.
Exercise programs designed to improve balance, strength and mobility can help to improve function and decrease risk of falling. However, individuals with hip OA may have difficulty participating in these programs due to pain. Aquatic exercise offers an activity alternative to improve mobility, strength and decrease fall risk. As well, the addition of a group program designed to enhance confidence in movement may further reduce the risk of falls by improving independence to be more active at home and in the community.
This project will evaluate the effect of aquatic exercise and aquatic exercise combined with a group educational program on decreasing fall risk in older adults with hip OA. Determining optimal fall prevention programs may avert death and loss of quality of life for older adults, clearly an important contribution to preventative health care.
- Conditions
- Arthritis
- Being tested
- exercise, 2, Control
- Keywords
- older adults, falls, arthritis, aquatic, exercise
- Medical subject headings
- Arthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
A community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls.
2Behavioural
Same as 1 with the addition of a 1/week educational group program to improve confidence in movement, learn about fall risk and fall prevention and the rationale for the exercises to decrease fall risk.
ControlBehavioural
no exercise
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Education | Experimental | Exercise combined with education Receives: Behavioral: 2 |
| Aquatic | Experimental | Not described Receives: Behavioral: exercise |
| Control | Placebo comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Balance
Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)
Measured: baseline and 11 weeks
Change in Chair Stands
change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)
Measured: baseline and 11 weeks
Change in Walking
change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks
Measured: baseline and 11 weeks
Change in Falls-Efficacy
change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)
Measured: baseline and 11 weeks
Change in Dual Task Function
change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)
Measured: baseline and 11 weeks
Secondary outcomes (1)
Change in Physical Activity
change in Physical Activity Scale for the Elderly (0 - up to 300, higher score more active)
Measured: baseline and 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startOct 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArthritisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Cathy M Arnold, MSc, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289458
- Sponsor's protocol ID
- BIO-REB 05-158
- Status last verified
- Jul 2010
- First submitted
- 7 Feb 2006
- Last updated
- 3 Aug 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aquatic Exercise and Aquatic Exercise Combined With Education and Efficacy Enhancement on Improving Indices of Fall Risk in Older Adults With Hip Osteoarthritis: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00289458
- Acronym / sponsor ID
- BIO-REB 05-158
- Conditions
- Arthritis
- Keywords
- older adults, falls, arthritis, aquatic, exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 9 Feb 2006 (estimated)
- Results
- Posted 3 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to determine the effect of aquatic exercise and aquatic exercise combined with an education program on decreasing fall risk in older adults with hip osteoarthritis. The hypothesis is that aquatic exercise will improve function, strength and balance and the addition of the education session will enhance confidence in movement.
Detailed description
Older adults with hip osteoarthritis (OA) often experience pain and loss of mobility that significantly impairs their ability to walk, climb stairs, shop or participate in exercise programs. This can result in social isolation, depression and loss of confidence in their ability to manage independently in the community. A decline in physical and psycho-social function leads to increased risk of falling. It is crucial to identify high-risk fallers as well as the best interventions to decrease that risk; hip fractures from falls are devastating, resulting in death or admission to long-term care for the majority who sustain them.
Exercise programs designed to improve balance, strength and mobility can help to improve function and decrease risk of falling. However, individuals with hip OA may have difficulty participating in these programs due to pain. Aquatic exercise offers an activity alternative to improve mobility, strength and decrease fall risk. As well, the addition of a group program designed to enhance confidence in movement may further reduce the risk of falls by improving independence to be more active at home and in the community.
This project will evaluate the effect of aquatic exercise and aquatic exercise combined with a group educational program on decreasing fall risk in older adults with hip OA. Determining optimal fall prevention programs may avert death and loss of quality of life for older adults, clearly an important contribution to preventative health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aquatic Education | Experimental | Behavioral: 2Exercise combined with education |
| Aquatic | Experimental | Behavioral: exercise |
| Control | Placebo comparator | Behavioral: Control |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- over age 65
- clinical diagnosis of hip osteoarthritis
Key exclusion criteria (2 listed)
- medical condition tha significantly decreases functional ability such that not safe to exercise in a community program
- already exercising in a moderate exercise program 2/week or more
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 |
|---|---|---|
| exerciseA community aquatic exercise program designed for older adults to improve balance, strength and mobility to decrease the risk of falls. | Behavioural | Aquatic |
| 2Same as 1 with the addition of a 1/week educational group program to improve confidence in movement, learn about fall risk and fall prevention and the rationale for the exercises to decrease fall risk. | Behavioural | Aquatic Education |
| Controlno exercise | Behavioural | Control |
Primary outcome
Change in Balance
Time frame: baseline and 11 weeks
Berg Balance Scale range 0 - 36 (36 is excellent balance, 0 is poor or no ability for standing balance)
Change in Chair Stands
Time frame: baseline and 11 weeks
change in number of repetitions (the number of times moving from full sitting to full standing in 30 seconds)
Change in Walking
Time frame: baseline and 11 weeks
change in 6 minute walk (distance in meters covered in 6 minutes)over 11 weeks
Change in Falls-Efficacy
Time frame: baseline and 11 weeks
change in Activities Balance Confidence Scale (0 - 100, 100 represents high confidence, 0 represents low confidence)
Change in Dual Task Function
Time frame: baseline and 11 weeks
change in Timed Up and Go Cognitive Test (time in sec., lower number means better performance)
1 secondary outcome
Change in Physical Activity
Time frame: baseline and 11 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MSc 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 Phase 1 study testing exercise and 2 in people with Arthritis, 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 2 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 3 Aug 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Balance (time frame: baseline and 11 weeks). 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 3 Aug 2010.