Hip FracturesREATIVENCT02295527
Functional Later Rehabilitation in Older Adults: Effectiveness of Physical Exercises
A study testing Home-based physical exercise intervention in people with Hip Fractures, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
Hip fractures resulting from falls increase substantially with advancing age and less than a half of the elderly that have sustained and survived after the surgery regain their former levels of mobility. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Home-based physical exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2014to Dec 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- After the first hip fragility fracture following a fall from standing height or while turning
- Surgically treated in the later stage of rehabilitation phase (6 months up to 2 years after the fracture).
Who cannot join
- Sustained a hip fracture trauma due to falls from higher surfaces or motor vehicle accidents or due to a tumors or disease (other than osteoporosis)
- Several cognitive impairment, assessed by Mini-Mental State Examination adjusted for educational level [22];
- Inability to walk, either with walking aid;
- Progressive or severe neurological disease (e.g., Parkinson's disease, stroke);
- Communication disability (several uncompensated visual or hearing deficits);
- Medical condition contraindications exercise (e.g. unstable angina, severe valvular heart disease, large or expanding aortic aneurysm, etc.) [23];
- Engaged in a regular exercise program, with a frequency more or equal than twice a week, 30 minutes a day (excluding walking and senior dance) [24].
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Cidade de São Paulo
São Paulo, São Paulo, 08371-110
Monica R Perracini, Phd, +551121781565, monica.perracini@unicid.edu.br
Camila A Lima, +5511992105950, camilabrown@hotmail.com
About this study
Official title: Effectiveness of a Physical Exercise Intervention Program in Improving Functional Mobility in Older Adults After Hip Fracture in Later Stage Rehabilitation: a Randomized Clinical Trial
Hip fractures resulting from falls increase substantially with advancing age and less than a half of the elderly that have sustained and survived after the surgery regain their former levels of mobility. There is increasing evidence that rehabilitation interventions involving exercises and extended beyond the sub acute phase or even in a later stage of care have a positive impact on various functional abilities. The purpose of this study is to determine if an exercise program training for people who have suffered a fall-related hip fracture will improve functional mobility when compared with usual care. Randomized controlled trial using blinded assessors and intention-to-treat analysis. We will recruit 82 older adults, 60 years or over who have suffered a hip fracture due to a fall and have or have not completed physiotherapy and/or rehabilitation. These participants will be in a later stage rehabilitation phase (6 months up to 2 years after the fracture). Participants randomized to the Intervention Group (IG) will be submitted to a physical exercise program involving a progressive and challenging balance training and a neuromuscular and functional training of the lower limbs, conducted at home by physiotherapists, once a week, lasting about one hour, in the first, second and third month after randomization and will be oriented to perform exercises, twice a week, through a booklet. Visits to follow up exercises progression will be conducted once a month, from de fourth to the sixth month and each two months until the end of the follow up at the 12th month, summing up 18 sessions. Participants will receive monthly phone calls to increase exercise adherence. The control group will receive usual care. The primary outcome will be mobility-related disability and participants will be assessed in the baseline, at the end of the intervention (3 months), at 6 and 12 months. The participants will receive monthly phone calls to investigate falls and exercise adherence. Adverse effects will be monitored.
Read the detailed description
Over a lifetime, about half of women and a quarter of men will suffer a fragility bone fracture [1, 2], mostly due to falling [2]. Among the most serious and common fractures are hip fractures, reaching significant levels of mortality [2] and disability [3]. Hip fracture is an increasingly important problem internationally, particularly in developing countries, due to the growth in the numbers of older people. It is estimated that in 2050 the global number of hip fractures will be between 7.3 and 21.3 million [4] and the cost with the treatment will be approximately of 131.5 billion dollars [5], due the population increase.
Physical and psychological limitations post-fracture, such as decreased mobility [6] and muscle strength of lower limbs [7], deficit balance [6], lack of trust [7], fear of falling [6] and increased risk of falls [8], hamper around 40% of older people from returning to their daily activities to live independently and safely [3, 9]. Even after two years of injury, more than half of the elderly do not regain the functional level prior to injury [10], persisting with moderate to high risk of falls [6].
Risk of falls and future falls in this population may be due either to physical limitations [11, 12] (due to insufficient recovery of balance, muscle strength and consequently mobility) and the fact they have already suffered a fracture previously [13], further increasing the chances of new fractures in this population [14].
There is no consensus about the best intervention for functionality of the elderly after hip fracture. However, recently different exercise programs have been suggested to improve the mobility of these patients [8]. Some studies have shown the effectiveness of rehabilitation programs in the period of up to 6 months after injury [15-18]. Although, few studies have explored the late period rehabilitation (over 6 months) [19, 20], when functional limitations can persist due to inadequate dose as well as the type of exercise performed. Population in Brazil is growing age in one of the fastest rates in the world and will be even greater in the coming decades. The number of seniors will double between 2002 and 2020, from 15 million to 32 million and reach 64 million by 2050 (about 30% of the total population in Brazil) [21]. Furthermore, the elderly aged 80 and over will increase exponentially over the next four decades, putting a growing and disproportionate demand on the health system and social support [21].
The purpose of this study is to determine if an exercise program training for people who have suffered a fall-related hip fracture will improve functional mobility when compared with usual care.
- Conditions
- Hip Fractures
- Being tested
- Home-based physical exercise intervention, Control Group Usual Care
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based physical exercise interventionOther
Also called REATIVE
Progressive strengthening of muscle groups ankle dorsi flexors, knee extensors and hip abductors and progressive balance training according to individual capacity:weight-bearing, limits of stability, change of position/direction, maintenance of static and dynamic stability, anticipatory adjustments using different bases of support and different sensory conditions. Dynamic exercises involving spin on its own axis, sitting and standing, up and down stairs, functional reach, steps in different directions and walk training. In the first session the physiotherapist will choose two exercises that best address the participant function goals and will add more exercises each week according to the level of participants' ability and motivation. Participants will receive a detailed booklet, containing photos and instructions of the12 exercises.Visits to follow up exercises will be conducted by the physiotherapists to progress the exercises.
Control Group Usual CareOther
Also called Usual care
This group will receive usual care and will not have any disadvantage in participating in the study. We understand that usual care is what participant receives based on the network of health care in which he/she is inserted. The participants will receive at baseline assessment a diary falls logbook and a guidance booklet containing information about prevention of falls, fractures and bone health that will be explained at the moment.
| Study group | Role | What they receive |
|---|---|---|
| Home-based physical exercise | Experimental | Participants randomized to the Intervention Group (IG) will be submitted to a physical exercise program involving a progressive and challenging balance training and a neuromuscular and functional training of the lower limbs, conducted at home by physiotherapists, once a week, lasting about one hour, in the first, second and third month after randomization and will be oriented to perform exercises, twice a week, through a booklet. Visits to follow up exercises progression will be conducted once a month, from de fourth to the sixth month and each two months until the end of the follow up at the 12th month, summing up 18 sessions. Participants will receive monthly phone calls to increase exercise adherence. Receives: Other: Home-based physical exercise intervention |
| Control Group Usual Care | Other | This group will receive usual care and the booklet regarding bone health information. Receives: Other: Control Group Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity function (Short Physical Performance Battery (SPPB)
will be measured by theSPPB [27], that consists of three blocks of tests that assess static balance, walking speed and, indirectly, the strength of the lower limbs (sitting and standing from a chair unassisted). Each test has a score of zero (worst performance) to 4 points (best performance), summing a total final score of 12 points. Change from baseline will be assessed at 6 and 12 months.
Measured: Change from baseline will be assessed at 6 and 12 months
Secondary outcomes (6)
Physiological risk of falls (Profile Physiological Assessment long version (PPA)
will be measured by the PPA [12] which provides an overall score for risk of falling through a series of tests that evaluates the systems involved in the postural stability system. The results are computed on a software specifically developed for the test that generates a report assessing the risk of falls including 4 components: the individuals score on a global chart of fall risk, profile of the individuals performance in the tests, indicating in a table individuals performance in relation to the standards of the same age. Additionally, individual score for muscle strength, reaction time test, balance, sway and coordination will be also ascertained. Change from baseline will be assessed at 6 and 12 months.
Measured: Change from baseline will be assessed at 6 and 12 months
Functional performance (WHO Disability Assessment Schedule (WHODAS II)
measured by the WHODAS II [29]. This scale measures the population health and functionality in 6 domains: cognition, mobility, self-care, interpersonal relationships, daily activities and participation. It was developed by WHO with theoretical model to the International Classification of Functioning, Disability and Health (ICF), and it is not intended for any specific health condition. This short version assesses the difficulty degree of performing 12 activities in past 30 days, which can be classified as none, mild, moderate, severe and extreme (cannot be performed). The degree of difficulty reported is based on the presence of increased effort, discomfort or pain, slowness or the presence of some change in the way of doing the activity. Change from baseline will be assessed at 6 and 12 months.
Measured: Change from baseline will be assessed at 6 and 12 months
Quality of life (WHOQOL-bref)
measured by WHOQOL-bref [30], consists of 26 questions divided in 4 domains: physical, psychological, social relationships and environment. The questionnaire is based on the last 2 weeks of the participant and evaluated, for example, how safe he/she feel in her/his daily life and how satisfied is he/she with his/her ability to perform daily life activities. Change from baseline will be assessed at 6 and 12 months.
Measured: Change from baseline will be assessed at 6 and 12 months
Physical activity intensity (Planned Exercise Questionnaire - IPEQ_W)
will be measured by the IPEQ_W [31], ten questions designed to measure physical activity planned and unplanned for older people. The version estimates the intensity of physical activity during the last week will be used. The participant will be questioned for the frequency (every day, 3-6 times per week, twice a week, once a week or less than once per week) and duration of activity (less than 15 minutes per day, more than 15 minutes and under 30 minutes per day, more than 30 minutes and less than 1 hour, less over 1 h and 2 h per day more and less than 4h per day 2h, 4h, and daily or more). The total score is derived by multiplying the frequency categories by categories of activity duration, expressed in hours per week. The ICC for the IPEQ_W total score was 0.81. The concurrent validity was adequate whereas the instrument was able to identify older people of different ages and degrees of disability. Change from baseline will be assessed at 6 and 12 months.
Measured: Change from baseline will be assessed at 6 and 12 months
Occurrence of falls
will be assessed by monthly phone calls to participants. They will be encouraged to fill the diary that containing the record daily and the number of falls. A structured questionnaire will be used to identify possible falls and their consequences. The intervention group will be compared to control group at 6 and 12 months follow-up in relation to the number of falls, the incidence of falls and the proportion of elderly fallers. Change from baseline will be assessed at 6 and 12 months.
Measured: Change from baseline will be assessed at 6 and 12 months
Usual gait speed (evaluate acceleration and deceleration using a stopwatch)
will be evaluated on a distance of 4.6 meters, including 2 meters for acceleration and 2 meters for deceleration using a stopwatch. The participant will be instructed to walk at their normal pace as if they were going to buy something at the grocery store. The time that the elderly takes to complete the course will be recorded three times. The computed velocity in meters per second will be calculated dividing the course in meters by the time taken to complete the course. The average of three attempts will be used. The use of walking aids will be allowed during the test [28]. Change from baseline will be assessed at 6 and 12 months.
Measured: Change from baseline will be assessed at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Rodrigues Perracini, Universidade Cidade de Sao Paulo
- Investigators
- Monica R Perracini, Phd, Principal investigator, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295527
- Sponsor's protocol ID
- CAAE: 27398814.7.0000.0064
- Acronym
- REATIVE
- Status last verified
- Nov 2017
- First submitted
- 3 Nov 2014
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Akesson K, Marsh D, Mitchell PJ, McLellan AR, Stenmark J, Pierroz DD, Kyer C, Cooper C; IOF Fracture Working Group. Capture the Fracture: a Best Practice Framework and global campaign to break the fragility fracture cycle. Osteoporos Int. 2013 Aug;24(8):2135-52. doi: 10.1007/s00198-013-2348-z. Epub 2013 Apr 16.
PubMed 23589162Johnell O, Kanis J. Epidemiology of osteoporotic fractures. Osteoporos Int. 2005 Mar;16 Suppl 2:S3-7. doi: 10.1007/s00198-004-1702-6. Epub 2004 Sep 8.
PubMed 15365697Magaziner J, Simonsick EM, Kashner TM, Hebel JR, Kenzora JE. Predictors of functional recovery one year following hospital discharge for hip fracture: a prospective study. J Gerontol. 1990 May;45(3):M101-7. doi: 10.1093/geronj/45.3.m101.
PubMed 2335719Gullberg B, Johnell O, Kanis JA. World-wide projections for hip fracture. Osteoporos Int. 1997;7(5):407-13. doi: 10.1007/pl00004148.
PubMed 9425497Johnell O. The socioeconomic burden of fractures: today and in the 21st century. Am J Med. 1997 Aug 18;103(2A):20S-25S; discussion 25S-26S. doi: 10.1016/s0002-9343(97)90023-1.
PubMed 9302894Shumway-Cook A, Ciol MA, Gruber W, Robinson C. Incidence of and risk factors for falls following hip fracture in community-dwelling older adults. Phys Ther. 2005 Jul;85(7):648-55.
PubMed 15982171Portegijs E, Edgren J, Salpakoski A, Kallinen M, Rantanen T, Alen M, Kiviranta I, Sihvonen S, Sipila S. Balance confidence was associated with mobility and balance performance in older people with fall-related hip fracture: a cross-sectional study. Arch Phys Med Rehabil. 2012 Dec;93(12):2340-6. doi: 10.1016/j.apmr.2012.05.022. Epub 2012 Jun 12.
PubMed 22698990Handoll HH, Sherrington C, Mak JC. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2011 Mar 16;(3):CD001704. doi: 10.1002/14651858.CD001704.pub4.
PubMed 21412873Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. doi: 10.1093/ageing/afl084.
PubMed 16926202Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, Felsenthal G, Kenzora J. Recovery from hip fracture in eight areas of function. J Gerontol A Biol Sci Med Sci. 2000 Sep;55(9):M498-507. doi: 10.1093/gerona/55.9.m498.
PubMed 10995047Sherrington C, Tiedemann A, Cameron I. Physical exercise after hip fracture: an evidence overview. Eur J Phys Rehabil Med. 2011 Jun;47(2):297-307. Epub 2011 May 10.
PubMed 21555983Lord SR, Menz HB, Tiedemann A. A physiological profile approach to falls risk assessment and prevention. Phys Ther. 2003 Mar;83(3):237-52.
PubMed 12620088Perracini MR, Ramos LR. [Fall-related factors in a cohort of elderly community residents]. Rev Saude Publica. 2002 Dec;36(6):709-16. doi: 10.1590/s0034-89102002000700008. Portuguese.
PubMed 12488937Berry SD, Samelson EJ, Hannan MT, McLean RR, Lu M, Cupples LA, Shaffer ML, Beiser AL, Kelly-Hayes M, Kiel DP. Second hip fracture in older men and women: the Framingham Study. Arch Intern Med. 2007 Oct 8;167(18):1971-6. doi: 10.1001/archinte.167.18.1971.
PubMed 17923597Binder EF, Brown M, Sinacore DR, Steger-May K, Yarasheski KE, Schechtman KB. Effects of extended outpatient rehabilitation after hip fracture: a randomized controlled trial. JAMA. 2004 Aug 18;292(7):837-46. doi: 10.1001/jama.292.7.837.
PubMed 15315998
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Physical Exercise Intervention Program in Improving Functional Mobility in Older Adults After Hip Fracture in Later Stage Rehabilitation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02295527
- Acronym / sponsor ID
- REATIVE / CAAE: 27398814.7.0000.0064
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Nov 2014 (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.
Hip fractures resulting from falls increase substantially with advancing age and less than a half of the elderly that have sustained and survived after the surgery regain their former levels of mobility. There is increasing evidence that rehabilitation interventions involving exercises and extended beyond the sub acute phase or even in a later stage of care have a positive impact on various functional abilities. The purpose of this study is to determine if an exercise program training for people who have suffered a fall-related hip fracture will improve functional mobility when compared with usual care. Randomized controlled trial using blinded assessors and intention-to-treat analysis. We will recruit 82 older adults, 60 years or over who have suffered a hip fracture due to a fall and have or have not completed physiotherapy and/or rehabilitation. These participants will be in a later stage rehabilitation phase (6 months up to 2 years after the fracture). Participants randomized to the Intervention Group (IG) will be submitted to a physical exercise program involving a progressive and challenging balance training and a neuromuscular and functional training of the lower limbs, conducted at home by physiotherapists, once a week, lasting about one hour, in the first, second and third month after randomization and will be oriented to perform exercises, twice a week, through a booklet. Visits to follow up exercises progression will be conducted once a month, from de fourth to the sixth month and each two months until the end of the follow up at the 12th month, summing up 18 sessions. Participants will receive monthly phone calls to increase exercise adherence. The control group will receive usual care. The primary outcome will be mobility-related disability and participants will be assessed in the baseline, at the end of the intervention (3 months), at 6 and 12 months. The participants will receive monthly phone calls to investigate falls and exercise adherence. Adverse effects will be monitored.
Detailed description
Over a lifetime, about half of women and a quarter of men will suffer a fragility bone fracture [1, 2], mostly due to falling [2]. Among the most serious and common fractures are hip fractures, reaching significant levels of mortality [2] and disability [3]. Hip fracture is an increasingly important problem internationally, particularly in developing countries, due to the growth in the numbers of older people. It is estimated that in 2050 the global number of hip fractures will be between 7.3 and 21.3 million [4] and the cost with the treatment will be approximately of 131.5 billion dollars [5], due the population increase.
Physical and psychological limitations post-fracture, such as decreased mobility [6] and muscle strength of lower limbs [7], deficit balance [6], lack of trust [7], fear of falling [6] and increased risk of falls [8], hamper around 40% of older people from returning to their daily activities to live independently and safely [3, 9]. Even after two years of injury, more than half of the elderly do not regain the functional level prior to injury [10], persisting with moderate to high risk of falls [6].
Risk of falls and future falls in this population may be due either to physical limitations [11, 12] (due to insufficient recovery of balance, muscle strength and consequently mobility) and the fact they have already suffered a fracture previously [13], further increasing the chances of new fractures in this population [14].
There is no consensus about the best intervention for functionality of the elderly after hip fracture. However, recently different exercise programs have been suggested to improve the mobility of these patients [8]. Some studies have shown the effectiveness of rehabilitation programs in the period of up to 6 months after injury [15-18]. Although, few studies have explored the late period rehabilitation (over 6 months) [19, 20], when functional limitations can persist due to inadequate dose as well as the type of exercise performed. Population in Brazil is growing age in one of the fastest rates in the world and will be even greater in the coming decades. The number of seniors will double between 2002 and 2020, from 15 million to 32 million and reach 64 million by 2050 (about 30% of the total population in Brazil) [21]. Furthermore, the elderly aged 80 and over will increase exponentially over the next four decades, putting a growing and disproportionate demand on the health system and social support [21].
The purpose of this study is to determine if an exercise program training for people who have suffered a fall-related hip fracture will improve functional mobility when compared with usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based physical exercise | Experimental | Other: Home-based physical exercise interventionParticipants randomized to the Intervention Group (IG) will be submitted to a physical exercise program involving a progressive and challenging balance training and a neuromuscular and functional training of the lower limbs, conducted at home by physiotherapists, once a week, lasting about one hour, in the first, second and third month after randomization and will be oriented to perform exercises, twice a week, through a booklet. Visits to follow up exercises progression will be conducted once a month, from de fourth to the sixth month and each two months until the end of the follow up at the 12th month, summing up 18 sessions. Participants will receive monthly phone calls to increase exercise adherence. |
| Control Group Usual Care | Other | Other: Control Group Usual CareThis group will receive usual care and the booklet regarding bone health information. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- After the first hip fragility fracture following a fall from standing height or while turning
- Surgically treated in the later stage of rehabilitation phase (6 months up to 2 years after the fracture).
Key exclusion criteria (7 listed)
- Sustained a hip fracture trauma due to falls from higher surfaces or motor vehicle accidents or due to a tumors or disease (other than osteoporosis)
- Several cognitive impairment, assessed by Mini-Mental State Examination adjusted for educational level [22];
- Inability to walk, either with walking aid;
- Progressive or severe neurological disease (e.g., Parkinson's disease, stroke);
- Communication disability (several uncompensated visual or hearing deficits);
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 |
|---|---|---|
| Home-based physical exercise interventionAlso: REATIVEProgressive strengthening of muscle groups ankle dorsi flexors, knee extensors and hip abductors and progressive balance training according to individual capacity:weight-bearing, limits of stability, change of position/direction, maintenance of static and dynamic stability, anticipatory adjustments using different bases of support and different sensory conditions. Dynamic exercises involving spin on its own axis, sitting and standing, up and down stairs, functional reach, steps in different directions and walk training. In the first session the physiotherapist will choose two exercises that best address the participant function goals and will add more exercises each week according to the level of participants' ability and motivation. Participants will receive a detailed booklet, containing photos and instructions of the12 exercises.Visits to follow up exercises will be conducted by the physiotherapists to progress the exercises. | Other | Home-based physical exercise |
| Control Group Usual CareAlso: Usual careThis group will receive usual care and will not have any disadvantage in participating in the study. We understand that usual care is what participant receives based on the network of health care in which he/she is inserted. The participants will receive at baseline assessment a diary falls logbook and a guidance booklet containing information about prevention of falls, fractures and bone health that will be explained at the moment. | Other | Control Group Usual Care |
Primary outcome
Lower extremity function (Short Physical Performance Battery (SPPB)
Time frame: Change from baseline will be assessed at 6 and 12 months
will be measured by theSPPB [27], that consists of three blocks of tests that assess static balance, walking speed and, indirectly, the strength of the lower limbs (sitting and standing from a chair unassisted). Each test has a score of zero (worst performance) to 4 points (best performance), summing a total final score of 12 points. Change from baseline will be assessed at 6 and 12 months.
6 secondary outcomes
Physiological risk of falls (Profile Physiological Assessment long version (PPA)
Time frame: Change from baseline will be assessed at 6 and 12 months
Functional performance (WHO Disability Assessment Schedule (WHODAS II)
Time frame: Change from baseline will be assessed at 6 and 12 months
Quality of life (WHOQOL-bref)
Time frame: Change from baseline will be assessed at 6 and 12 months
Physical activity intensity (Planned Exercise Questionnaire - IPEQ_W)
Time frame: Change from baseline will be assessed at 6 and 12 months
Occurrence of falls
Time frame: Change from baseline will be assessed at 6 and 12 months
Usual gait speed (evaluate acceleration and deceleration using a stopwatch)
Time frame: Change from baseline will be assessed at 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Background: PubMed 23589162Akesson K, Marsh D, Mitchell PJ, McLellan AR, Stenmark J, Pierroz DD, Kyer C, Cooper C; IOF Fracture Working Group. Capture the Fracture: a Best Practice Framework and global campaign to break the fragility fracture cycle. Osteoporos Int. 2013 Aug;24(8):2135-52. doi: 10.1007/s00198-013-2348-z. Epub 2013 Apr 16.
- Background: PubMed 15365697Johnell O, Kanis J. Epidemiology of osteoporotic fractures. Osteoporos Int. 2005 Mar;16 Suppl 2:S3-7. doi: 10.1007/s00198-004-1702-6. Epub 2004 Sep 8.
- Background: PubMed 2335719Magaziner J, Simonsick EM, Kashner TM, Hebel JR, Kenzora JE. Predictors of functional recovery one year following hospital discharge for hip fracture: a prospective study. J Gerontol. 1990 May;45(3):M101-7. doi: 10.1093/geronj/45.3.m101.
- Background: PubMed 9425497Gullberg B, Johnell O, Kanis JA. World-wide projections for hip fracture. Osteoporos Int. 1997;7(5):407-13. doi: 10.1007/pl00004148.
- Background: PubMed 9302894Johnell O. The socioeconomic burden of fractures: today and in the 21st century. Am J Med. 1997 Aug 18;103(2A):20S-25S; discussion 25S-26S. doi: 10.1016/s0002-9343(97)90023-1.
- Background: PubMed 15982171Shumway-Cook A, Ciol MA, Gruber W, Robinson C. Incidence of and risk factors for falls following hip fracture in community-dwelling older adults. Phys Ther. 2005 Jul;85(7):648-55.
- Background: PubMed 22698990Portegijs E, Edgren J, Salpakoski A, Kallinen M, Rantanen T, Alen M, Kiviranta I, Sihvonen S, Sipila S. Balance confidence was associated with mobility and balance performance in older people with fall-related hip fracture: a cross-sectional study. Arch Phys Med Rehabil. 2012 Dec;93(12):2340-6. doi: 10.1016/j.apmr.2012.05.022. Epub 2012 Jun 12.
- Background: PubMed 21412873Handoll HH, Sherrington C, Mak JC. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2011 Mar 16;(3):CD001704. doi: 10.1002/14651858.CD001704.pub4.
- Background: PubMed 16926202Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. doi: 10.1093/ageing/afl084.
- Background: PubMed 10995047Magaziner J, Hawkes W, Hebel JR, Zimmerman SI, Fox KM, Dolan M, Felsenthal G, Kenzora J. Recovery from hip fracture in eight areas of function. J Gerontol A Biol Sci Med Sci. 2000 Sep;55(9):M498-507. doi: 10.1093/gerona/55.9.m498.
- Background: PubMed 21555983Sherrington C, Tiedemann A, Cameron I. Physical exercise after hip fracture: an evidence overview. Eur J Phys Rehabil Med. 2011 Jun;47(2):297-307. Epub 2011 May 10.
- Background: PubMed 12620088Lord SR, Menz HB, Tiedemann A. A physiological profile approach to falls risk assessment and prevention. Phys Ther. 2003 Mar;83(3):237-52.
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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.
Monica R Perracini, Phd principal investigator
Universidade Cidade de São 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 Home-based physical exercise intervention in people with Hip Fractures, run by Universidade Cidade de Sao Paulo 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 7 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: status not confirmed, as of the sponsor's last update on 28 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monica R Perracini, Phd (+551121781565, monica.perracini@unicid.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity function (Short Physical Performance Battery (SPPB) (time frame: Change from baseline will be assessed at 6 and 12 months). 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 NCT02295527, which also lists 32 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 28 Nov 2017.