Accidental FallsPhase 1NCT00187317
Evaluation of a Balance-recovery Specific Falls Prevention Exercise Program
A Phase 1 study testing Balance training (exercise) and Flexibility and relaxation exercise in people with Accidental Falls, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This study aims to investigate the potential to train compensatory stepping and grasping reactions for the prevention of falls. Read more about this study
- Who is it for?
- Ages 64 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Balance training (exercise) and Flexibility and relaxation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2005to Mar 2008
- Phase
- Phase 1
- 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 64 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community dwelling
- History of falls (at least 1 fall in the past 12 months) or poor balance
- Functional mobility (no dependence on mobility aids)
Who cannot join
- Neurological or musculoskeletal disorder
- Cognitive disorder (e.g. dementia)
- Osteoporosis
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Studies in Aging, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Development and Evaluation of a Perturbation-based Balance-training Program for Older Adults
This study aims to investigate the potential to train compensatory stepping and grasping reactions for the prevention of falls.
Read the detailed description
Physical activity and exercise have been shown to prevent falling in older adults, although the exact mechanisms by which exercise prevents falls is unclear. Compensatory stepping and grasping reactions are frequently used to prevent a fall to the ground following a loss of balance. Age-related impairment in these reactions may be related to an increased risk of falling. Therefore, the purpose of this study is to investigate means for reversing age-related impairment in compensatory stepping and grasping reactions. A training program involving perturbation-evoked reactions will be evaluated.
Comparison(s): Balance recovery ability before and after a 6-week training program will be assessed. Performance of the training group will be compared to a control group not receiving stepping and grasping training.
- Conditions
- Accidental Falls
- Being tested
- Balance training (exercise), Flexibility and relaxation exercise
- Keywords
- Exercise, Rehabilitation, Postural Balance, Accidental Falls, Geriatrics
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance training (exercise)Behavioural
Perturbation-based balance training. 30-minute sessions three times per week for six weeks.
Flexibility and relaxation exerciseOther
30-minute sessions, three times per week for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| PERT | Experimental | Perturbation-based balance training. Receives: Behavioral: Balance training (exercise) |
| CON | Placebo comparator | Flexibility and relaxation training. Receives: Other: Flexibility and relaxation exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to recover balance by stepping and grasping
Measured: Before and after 6-week intervention
Secondary outcomes (1)
Fall frequency; clinical measures related to balance and fall risk (e.g. FallScreen, Community Balance and Mobility Scale, balance confidence)
Measured: One year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2005
- Primary completionMar 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Brian Maki, PhD, PEng, Principal investigator, Sunnybrook & Women's College Health Sciences Centre; University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187317
- Sponsor's protocol ID
- NET-54025-01
- Status last verified
- Apr 2010
- First submitted
- 9 Sep 2005
- Last updated
- 2 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Maki BE, McIlroy WE, Perry SD. Influence of lateral destabilization on compensatory stepping responses. J Biomech. 1996 Mar;29(3):343-53. doi: 10.1016/0021-9290(95)00053-4.
PubMed 8850640Province MA, Hadley EC, Hornbrook MC, Lipsitz LA, Miller JP, Mulrow CD, Ory MG, Sattin RW, Tinetti ME, Wolf SL. The effects of exercise on falls in elderly patients. A preplanned meta-analysis of the FICSIT Trials. Frailty and Injuries: Cooperative Studies of Intervention Techniques. JAMA. 1995 May 3;273(17):1341-7.
PubMed 7715058Rogers MW, Johnson ME, Martinez KM, Mille ML, Hedman LD. Step training improves the speed of voluntary step initiation in aging. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):46-51. doi: 10.1093/gerona/58.1.m46.
PubMed 12560410McIlroy WE, Maki BE. Age-related changes in compensatory stepping in response to unpredictable perturbations. J Gerontol A Biol Sci Med Sci. 1996 Nov;51(6):M289-96. doi: 10.1093/gerona/51a.6.m289.
PubMed 8914501Maki BE, McIlroy WE. Change-in-support balance reactions in older persons: an emerging research area of clinical importance. Neurol Clin. 2005 Aug;23(3):751-83, vi-vii. doi: 10.1016/j.ncl.2005.01.002. No abstract available.
PubMed 16026675Maki BE, Cheng KC, Mansfield A, Scovil CY, Perry SD, Peters AL, McKay S, Lee T, Marquis A, Corbeil P, Fernie GR, Liu B, McIlroy WE. Preventing falls in older adults: new interventions to promote more effective change-in-support balance reactions. J Electromyogr Kinesiol. 2008 Apr;18(2):243-54. doi: 10.1016/j.jelekin.2007.06.005. Epub 2007 Sep 4.
PubMed 17766146Mansfield A, Peters AL, Liu BA, Maki BE. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial. BMC Geriatr. 2007 May 31;7:12. doi: 10.1186/1471-2318-7-12.
PubMed 17540020Mansfield A, Peters AL, Liu BA, Maki BE. Effect of a perturbation-based balance training program on compensatory stepping and grasping reactions in older adults: a randomized controlled trial. Phys Ther. 2010 Apr;90(4):476-91. doi: 10.2522/ptj.20090070. Epub 2010 Feb 18.
PubMed 20167644
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Perturbation-based Balance-training Program for Older Adults
- ClinicalTrials.gov ID
- NCT00187317
- Acronym / sponsor ID
- NET-54025-01
- Conditions
- Accidental Falls
- Keywords
- Exercise, Rehabilitation, Postural Balance, Accidental Falls, Geriatrics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 16 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.
This study aims to investigate the potential to train compensatory stepping and grasping reactions for the prevention of falls.
Detailed description
Physical activity and exercise have been shown to prevent falling in older adults, although the exact mechanisms by which exercise prevents falls is unclear. Compensatory stepping and grasping reactions are frequently used to prevent a fall to the ground following a loss of balance. Age-related impairment in these reactions may be related to an increased risk of falling. Therefore, the purpose of this study is to investigate means for reversing age-related impairment in compensatory stepping and grasping reactions. A training program involving perturbation-evoked reactions will be evaluated.
Comparison(s): Balance recovery ability before and after a 6-week training program will be assessed. Performance of the training group will be compared to a control group not receiving stepping and grasping training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PERT | Experimental | Behavioral: Balance training (exercise)Perturbation-based balance training. |
| CON | Placebo comparator | Other: Flexibility and relaxation exerciseFlexibility and relaxation training. |
Who may qualify
- Ages
- 64 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Community dwelling
- History of falls (at least 1 fall in the past 12 months) or poor balance
- Functional mobility (no dependence on mobility aids)
Key exclusion criteria (3 listed)
- Neurological or musculoskeletal disorder
- Cognitive disorder (e.g. dementia)
- Osteoporosis
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 |
|---|---|---|
| Balance training (exercise)Perturbation-based balance training. 30-minute sessions three times per week for six weeks. | Behavioural | PERT |
| Flexibility and relaxation exercise30-minute sessions, three times per week for six weeks. | Other | CON |
Primary outcome
Ability to recover balance by stepping and grasping
Time frame: Before and after 6-week intervention
1 secondary outcome
Fall frequency; clinical measures related to balance and fall risk (e.g. FallScreen, Community Balance and Mobility Scale, balance confidence)
Time frame: One year post-intervention
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 2 Apr 2010.
- Background: PubMed 8850640Maki BE, McIlroy WE, Perry SD. Influence of lateral destabilization on compensatory stepping responses. J Biomech. 1996 Mar;29(3):343-53. doi: 10.1016/0021-9290(95)00053-4.
- Background: PubMed 7715058Province MA, Hadley EC, Hornbrook MC, Lipsitz LA, Miller JP, Mulrow CD, Ory MG, Sattin RW, Tinetti ME, Wolf SL. The effects of exercise on falls in elderly patients. A preplanned meta-analysis of the FICSIT Trials. Frailty and Injuries: Cooperative Studies of Intervention Techniques. JAMA. 1995 May 3;273(17):1341-7.
- Background: PubMed 12560410Rogers MW, Johnson ME, Martinez KM, Mille ML, Hedman LD. Step training improves the speed of voluntary step initiation in aging. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):46-51. doi: 10.1093/gerona/58.1.m46.
- Background: PubMed 8914501McIlroy WE, Maki BE. Age-related changes in compensatory stepping in response to unpredictable perturbations. J Gerontol A Biol Sci Med Sci. 1996 Nov;51(6):M289-96. doi: 10.1093/gerona/51a.6.m289.
- Background: PubMed 16026675Maki BE, McIlroy WE. Change-in-support balance reactions in older persons: an emerging research area of clinical importance. Neurol Clin. 2005 Aug;23(3):751-83, vi-vii. doi: 10.1016/j.ncl.2005.01.002. No abstract available.
- Background: PubMed 17766146Maki BE, Cheng KC, Mansfield A, Scovil CY, Perry SD, Peters AL, McKay S, Lee T, Marquis A, Corbeil P, Fernie GR, Liu B, McIlroy WE. Preventing falls in older adults: new interventions to promote more effective change-in-support balance reactions. J Electromyogr Kinesiol. 2008 Apr;18(2):243-54. doi: 10.1016/j.jelekin.2007.06.005. Epub 2007 Sep 4.
- Results publication: PubMed 17540020Mansfield A, Peters AL, Liu BA, Maki BE. A perturbation-based balance training program for older adults: study protocol for a randomised controlled trial. BMC Geriatr. 2007 May 31;7:12. doi: 10.1186/1471-2318-7-12.
- Results publication: PubMed 20167644Mansfield A, Peters AL, Liu BA, Maki BE. Effect of a perturbation-based balance training program on compensatory stepping and grasping reactions in older adults: a randomized controlled trial. Phys Ther. 2010 Apr;90(4):476-91. doi: 10.2522/ptj.20090070. Epub 2010 Feb 18.
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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.
Brian Maki, PhD, PEng principal investigator
Sunnybrook & Women's College Health Sciences Centre; University of Toronto
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 Balance training (exercise) and Flexibility and relaxation exercise in people with Accidental Falls, run by Sunnybrook Health Sciences Centre 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 3 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 2 Apr 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?
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?
Ability to recover balance by stepping and grasping (time frame: Before and after 6-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00187317, which also lists 8 linked publications.
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 2 Apr 2010.