Functional Later Rehabilitation in Older Adults: Effectiveness of Physical Exercises
NCT ID: NCT02295527
Last Updated: 2017-11-28
Study Results
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Basic Information
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UNKNOWN
NA
82 participants
INTERVENTIONAL
2014-11-30
2019-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Home-based physical exercise
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.
Home-based physical exercise intervention
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 Care
This group will receive usual care and the booklet regarding bone health information.
Control Group 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.
Interventions
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Home-based physical exercise intervention
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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Surgically treated in the later stage of rehabilitation phase (6 months up to 2 years after the fracture).
Exclusion Criteria
* 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) \[24\].
60 Years
ALL
No
Sponsors
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Universidade Cidade de Sao Paulo
OTHER
Responsible Party
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Monica Rodrigues Perracini
Professor at Master's and Doctoral Programs in Physical Therapy
Principal Investigators
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Monica R Perracini, Phd
Role: PRINCIPAL_INVESTIGATOR
Universidade Cidade de São Paulo
Locations
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Universidade Cidade de São Paulo
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Monica R Perracini, Phd
Role: primary
Camila A Lima
Role: backup
References
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Lima CA, Sherrington C, Guaraldo A, Moraes SA, Varanda RD, Melo JA, Kojima KE, Perracini M. Effectiveness of a physical exercise intervention program in improving functional mobility in older adults after hip fracture in later stage rehabilitation: protocol of a randomized clinical trial (REATIVE Study). BMC Geriatr. 2016 Nov 29;16(1):198. doi: 10.1186/s12877-016-0370-7.
Other Identifiers
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CAAE: 27398814.7.0000.0064
Identifier Type: -
Identifier Source: org_study_id