Accidental FallsNCT02541305
EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM IN INSTITUTIONALIZED ELDERLY
A study testing propioceptive program and No propioceptive program in people with Accidental Falls, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
Knowing the effects of proprioceptive exercise program in improving balance, gait and risk of falls in institutionalized elderly. Read more about this study
- Who is it for?
- Ages 65 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- propioceptive program and No propioceptive program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2015to Dec 2015
- 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 85 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being institutionalized,
- own ability to read and write,
- and access the study voluntarily.
Who cannot join
- Significant degree of cognitive impairment;
- intolerance moderate physical activity, caused by cardiovascular or respiratory disease,
- as well as those who did not complete 90% of the sessions.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz
Badajoz, Extremadura, 06006
About this study
Official title: EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM ON PREDICTORS OF RISK OF FALLS IN INSTITUTIONALIZED ELDERLY
Knowing the effects of proprioceptive exercise program in improving balance, gait and risk of falls in institutionalized elderly.
Read the detailed description
The aim of this study will be to determine the effects of proprioceptive exercise program in improving balance and gait as well as reducing the risk of falls in institutionalized elderly in a healthcare center. To evaluate this effect, a total of 45 subjects will participate in a longitudinal and controlled trial. Inclusion criteria will be over 65 years olds, be institutionalized in the center and have ability to read and write.
Thereafter, participants will be separated into two different groups (experimental and control). Randomization was performed using sealed envelopes with different numbers of intervention inside. Both groups will be evaluated both at the start of the first session and in the last working session.
The control group performed a geriatric revitalization program as the experimental group. Besides this one, experimental group performed a program of proprioceptive exercises. The intervention rate will 2 weekly sessions for 12 weeks for both groups (24 sessions), lasting 55 minutes. The variables analyzed were: the questionnaire risk of falls in hospital (MORSE), Tinetti scale, the test Timed Up and Go (TUG), the time of one leg and the Cooper test running 12 minutes.
The data analysis will perform using the Statistical Package for the Social Sciences (SPSS statistical software), version 19.0 for Windows, Chicago.
To determine the normal distribution of the data the Shapiro-Wilks test and comparison by ANOVA was performed. The values obtained in the pretest and posttest assessment for each variable will be compared by Student t test for related samples or by the Wilcoxon rank test.
- Conditions
- Accidental Falls
- Being tested
- propioceptive program, No propioceptive program
- Keywords
- falls prevention, proprioception, physical condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propioceptive programOther
The training program has 6 specific proprioceptive exercises, each five minutes long, which will conducted in static and dynamic positions for a period of 30 minutes. Each exercise session will include 55 minutes (15 minutes of warm-up with slow walk, mobility and stretching exercise, followed by 30 minutes of a propioceptive exercises program, and finishing with 10 minutes of cool down through stretching and relaxation exercises)
No propioceptive programOther
The control group continued to perform their daily activities without changing any habit. Geriatric revitalization program without proprioceptive exercises.
| Study group | Role | What they receive |
|---|---|---|
| Cotrol | Active comparator | No propioceptive program. Receives: Other: No propioceptive program |
| Experimental | Experimental | Propioceptive program Receives: Other: propioceptive program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Up and Go (TUG) test
Evaluates mobility testing both static balance and the dynamic by measuring the time taken to perform a task.
Measured: Participants will be followed an expected average of 5 weeks.
Secondary outcomes (4)
Tinnetti scale
It consists of two subscales, gait and balance, where less than 19 points overall results indicate a high risk of falling
Measured: Participants will be followed an expected average of 5 weeks.
Questionnaire risk of falls in hospital (Morse)
This questionnaire has 6 items with a total range of 0-125.
Measured: Participants will be followed an expected average of 5 weeks.
Cooper test
Walking for 12 minutes around cones along the floor.
Measured: Participants will be followed an expected average of 5 weeks.
Support time monopodal
Postural control is valued.
Measured: Participants will be followed an expected average of 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz
- Responsible party
- Principal investigator, JOSE VICENTE TOLEDO MARHUENDA, Universidad Miguel Hernandez de Elche
- Investigators
- María Ángeles Cardero-Durán, PhD, Principal investigator, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541305
- Sponsor's protocol ID
- JVT001
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2015
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mather AS, Rodriguez C, Guthrie MF, McHarg AM, Reid IC, McMurdo ME. Effects of exercise on depressive symptoms in older adults with poorly responsive depressive disorder: randomised controlled trial. Br J Psychiatry. 2002 May;180:411-5. doi: 10.1192/bjp.180.5.411.
PubMed 11983637Geiger RA, Allen JB, O'Keefe J, Hicks RR. Balance and mobility following stroke: effects of physical therapy interventions with and without biofeedback/forceplate training. Phys Ther. 2001 Apr;81(4):995-1005.
PubMed 11276182Iwamoto J, Suzuki H, Tanaka K, Kumakubo T, Hirabayashi H, Miyazaki Y, Sato Y, Takeda T, Matsumoto H. Preventative effect of exercise against falls in the elderly: a randomized controlled trial. Osteoporos Int. 2009 Jul;20(7):1233-40. doi: 10.1007/s00198-008-0794-9. Epub 2008 Nov 15.
PubMed 19011727Stathokostas L, Little RM, Vandervoort AA, Paterson DH. Flexibility training and functional ability in older adults: a systematic review. J Aging Res. 2012;2012:306818. doi: 10.1155/2012/306818. Epub 2012 Nov 8.
PubMed 23209904Hewitt J, Refshauge KM, Goodall S, Henwood T, Clemson L. Does progressive resistance and balance exercise reduce falls in residential aged care? Randomized controlled trial protocol for the SUNBEAM program. Clin Interv Aging. 2014 Feb 21;9:369-76. doi: 10.2147/CIA.S53931. eCollection 2014.
PubMed 24591821Jorstad EC, Hauer K, Becker C, Lamb SE; ProFaNE Group. Measuring the psychological outcomes of falling: a systematic review. J Am Geriatr Soc. 2005 Mar;53(3):501-10. doi: 10.1111/j.1532-5415.2005.53172.x.
PubMed 15743297Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.
PubMed 22071817Sturnieks DL, Finch CF, Close JC, Tiedemann A, Lord SR, Pascoe DA. Exercise for falls prevention in older people: assessing the knowledge of exercise science students. J Sci Med Sport. 2010 Jan;13(1):59-64. doi: 10.1016/j.jsams.2008.11.005. Epub 2009 Feb 20.
PubMed 19230765Orr R, Raymond J, Fiatarone Singh M. Efficacy of progressive resistance training on balance performance in older adults : a systematic review of randomized controlled trials. Sports Med. 2008;38(4):317-43. doi: 10.2165/00007256-200838040-00004.
PubMed 18348591Cameron ID, Gillespie LD, Robertson MC, Murray GR, Hill KD, Cumming RG, Kerse N. Interventions for preventing falls in older people in care facilities and hospitals. Cochrane Database Syst Rev. 2012 Dec 12;12:CD005465. doi: 10.1002/14651858.CD005465.pub3.
PubMed 23235623Barnett A, Smith B, Lord SR, Williams M, Baumand A. Community-based group exercise improves balance and reduces falls in at-risk older people: a randomised controlled trial. Age Ageing. 2003 Jul;32(4):407-14. doi: 10.1093/ageing/32.4.407.
PubMed 12851185O'Connell B, Myers H. The sensitivity and specificity of the Morse Fall Scale in an acute care setting. J Clin Nurs. 2002 Jan;11(1):134-6. doi: 10.1046/j.1365-2702.2002.00578.x. No abstract available.
PubMed 11845750Tinetti ME, Williams TF, Mayewski R. Fall risk index for elderly patients based on number of chronic disabilities. Am J Med. 1986 Mar;80(3):429-34. doi: 10.1016/0002-9343(86)90717-5.
PubMed 3953620Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
PubMed 10960937Vellas BJ, Wayne SJ, Romero L, Baumgartner RN, Rubenstein LZ, Garry PJ. One-leg balance is an important predictor of injurious falls in older persons. J Am Geriatr Soc. 1997 Jun;45(6):735-8. doi: 10.1111/j.1532-5415.1997.tb01479.x.
PubMed 9180669
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF AN EXERCISE PROPRIOCEPTIVE PROGRAM ON PREDICTORS OF RISK OF FALLS IN INSTITUTIONALIZED ELDERLY
- ClinicalTrials.gov ID
- NCT02541305
- Acronym / sponsor ID
- JVT001
- Conditions
- Accidental Falls
- Keywords
- falls prevention, proprioception, physical condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Socio- Health Center Puente Real ( Health Care for Older © ) of Badajoz
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Sep 2015 (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.
Knowing the effects of proprioceptive exercise program in improving balance, gait and risk of falls in institutionalized elderly.
Detailed description
The aim of this study will be to determine the effects of proprioceptive exercise program in improving balance and gait as well as reducing the risk of falls in institutionalized elderly in a healthcare center. To evaluate this effect, a total of 45 subjects will participate in a longitudinal and controlled trial. Inclusion criteria will be over 65 years olds, be institutionalized in the center and have ability to read and write.
Thereafter, participants will be separated into two different groups (experimental and control). Randomization was performed using sealed envelopes with different numbers of intervention inside. Both groups will be evaluated both at the start of the first session and in the last working session.
The control group performed a geriatric revitalization program as the experimental group. Besides this one, experimental group performed a program of proprioceptive exercises. The intervention rate will 2 weekly sessions for 12 weeks for both groups (24 sessions), lasting 55 minutes. The variables analyzed were: the questionnaire risk of falls in hospital (MORSE), Tinetti scale, the test Timed Up and Go (TUG), the time of one leg and the Cooper test running 12 minutes.
The data analysis will perform using the Statistical Package for the Social Sciences (SPSS statistical software), version 19.0 for Windows, Chicago.
To determine the normal distribution of the data the Shapiro-Wilks test and comparison by ANOVA was performed. The values obtained in the pretest and posttest assessment for each variable will be compared by Student t test for related samples or by the Wilcoxon rank test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cotrol | Active comparator | Other: No propioceptive programNo propioceptive program. |
| Experimental | Experimental | Other: propioceptive programPropioceptive program |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Being institutionalized,
- own ability to read and write,
- and access the study voluntarily.
Key exclusion criteria (3 listed)
- Significant degree of cognitive impairment;
- intolerance moderate physical activity, caused by cardiovascular or respiratory disease,
- as well as those who did not complete 90% of the sessions.
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 |
|---|---|---|
| propioceptive programThe training program has 6 specific proprioceptive exercises, each five minutes long, which will conducted in static and dynamic positions for a period of 30 minutes. Each exercise session will include 55 minutes (15 minutes of warm-up with slow walk, mobility and stretching exercise, followed by 30 minutes of a propioceptive exercises program, and finishing with 10 minutes of cool down through stretching and relaxation exercises) | Other | Experimental |
| No propioceptive programThe control group continued to perform their daily activities without changing any habit. Geriatric revitalization program without proprioceptive exercises. | Other | Cotrol |
Primary outcome
Time Up and Go (TUG) test
Time frame: Participants will be followed an expected average of 5 weeks.
Evaluates mobility testing both static balance and the dynamic by measuring the time taken to perform a task.
4 secondary outcomes
Tinnetti scale
Time frame: Participants will be followed an expected average of 5 weeks.
Questionnaire risk of falls in hospital (Morse)
Time frame: Participants will be followed an expected average of 5 weeks.
Cooper test
Time frame: Participants will be followed an expected average of 5 weeks.
Support time monopodal
Time frame: Participants will be followed an expected average of 5 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 20 Jul 2023.
- Background: PubMed 11983637Mather AS, Rodriguez C, Guthrie MF, McHarg AM, Reid IC, McMurdo ME. Effects of exercise on depressive symptoms in older adults with poorly responsive depressive disorder: randomised controlled trial. Br J Psychiatry. 2002 May;180:411-5. doi: 10.1192/bjp.180.5.411.
- Background: PubMed 11276182Geiger RA, Allen JB, O'Keefe J, Hicks RR. Balance and mobility following stroke: effects of physical therapy interventions with and without biofeedback/forceplate training. Phys Ther. 2001 Apr;81(4):995-1005.
- Background: PubMed 19011727Iwamoto J, Suzuki H, Tanaka K, Kumakubo T, Hirabayashi H, Miyazaki Y, Sato Y, Takeda T, Matsumoto H. Preventative effect of exercise against falls in the elderly: a randomized controlled trial. Osteoporos Int. 2009 Jul;20(7):1233-40. doi: 10.1007/s00198-008-0794-9. Epub 2008 Nov 15.
- Background: PubMed 23209904Stathokostas L, Little RM, Vandervoort AA, Paterson DH. Flexibility training and functional ability in older adults: a systematic review. J Aging Res. 2012;2012:306818. doi: 10.1155/2012/306818. Epub 2012 Nov 8.
- Results publication: PubMed 24591821Hewitt J, Refshauge KM, Goodall S, Henwood T, Clemson L. Does progressive resistance and balance exercise reduce falls in residential aged care? Randomized controlled trial protocol for the SUNBEAM program. Clin Interv Aging. 2014 Feb 21;9:369-76. doi: 10.2147/CIA.S53931. eCollection 2014.
- Results publication: PubMed 15743297Jorstad EC, Hauer K, Becker C, Lamb SE; ProFaNE Group. Measuring the psychological outcomes of falling: a systematic review. J Am Geriatr Soc. 2005 Mar;53(3):501-10. doi: 10.1111/j.1532-5415.2005.53172.x.
- Results publication: PubMed 22071817Howe TE, Rochester L, Neil F, Skelton DA, Ballinger C. Exercise for improving balance in older people. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD004963. doi: 10.1002/14651858.CD004963.pub3.
- Results publication: PubMed 19230765Sturnieks DL, Finch CF, Close JC, Tiedemann A, Lord SR, Pascoe DA. Exercise for falls prevention in older people: assessing the knowledge of exercise science students. J Sci Med Sport. 2010 Jan;13(1):59-64. doi: 10.1016/j.jsams.2008.11.005. Epub 2009 Feb 20.
- Results publication: PubMed 18348591Orr R, Raymond J, Fiatarone Singh M. Efficacy of progressive resistance training on balance performance in older adults : a systematic review of randomized controlled trials. Sports Med. 2008;38(4):317-43. doi: 10.2165/00007256-200838040-00004.
- Results publication: PubMed 23235623Cameron ID, Gillespie LD, Robertson MC, Murray GR, Hill KD, Cumming RG, Kerse N. Interventions for preventing falls in older people in care facilities and hospitals. Cochrane Database Syst Rev. 2012 Dec 12;12:CD005465. doi: 10.1002/14651858.CD005465.pub3.
- Results publication: PubMed 12851185Barnett A, Smith B, Lord SR, Williams M, Baumand A. Community-based group exercise improves balance and reduces falls in at-risk older people: a randomised controlled trial. Age Ageing. 2003 Jul;32(4):407-14. doi: 10.1093/ageing/32.4.407.
- Results publication: PubMed 11845750O'Connell B, Myers H. The sensitivity and specificity of the Morse Fall Scale in an acute care setting. J Clin Nurs. 2002 Jan;11(1):134-6. doi: 10.1046/j.1365-2702.2002.00578.x. No abstract available.
- Individual participant dataSharing planned: No
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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.
María Ángeles Cardero-Durán, PhD principal investigator
University of Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propioceptive program and No propioceptive program in people with Accidental Falls, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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 20 Jul 2023. 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 Spain. 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?
Time Up and Go (TUG) test (time frame: Participants will be followed an expected average of 5 weeks.). 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 NCT02541305, which also lists 19 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 20 Jul 2023.