Addition of Aerobic Training to Conventional Rehabilitation After Femur Fracture
关键词
抽象
描述
Every year in Italy more than 100,000 persons aged > 65 incur in a hip fracture [Piscitelli et al. 2010; Tarantino et al. 2018]. The direct costs sustained by National Health System both for hospitalization and rehabilitation following hip fracture in elderly people were estimated in more than one billion euro [Tarantino et al. 2018; Rossini et al. 2005]. Despite incidence rate is decreasing in the last years, the number of hospitalizations for hip fractures is still increasing due to the population aging [Tarantino et al. 2018]. Some estimates assume that the number of fractures per year will double by 2050 [Tarantino et al. 2018; Brown et al. 2012]. Observational studies suggest that following hip fracture, only 40-60% of people who survive are likely to reach their prefracture level of mobility [Shah et al. 2001; Magaziner et al. 2000; Norton et al. 2000]. Up to 70% may recover their level of independence for basic activities of daily living [Shah et al. 2001; Norton et al. 2000; Beaupre et al. 2007] and less than half of all people experiencing hip fracture may regain their ability to perform instrumental ADLs [Vergara et al. 2014].
In Italy, as in Western nations, approximately 10-20% of patients are institutionalized after a hip fracture [Piscitelli et al. 2012], which imposes a large cost burden on society [Marottoli et al. 1994].Then, it is widely recognised that a vicious cycle can occur after a hip fracture where pain and hospitalization result in disuse atrophy of muscles and general low level of aerobic fitness which increases the risk of immobility and new fractures [French et al. 2008]. The aerobic fitness level of older adults is a primary determinant of health and morbidity and thus serves as a powerful predictor of quality of life and independent living [Taylor et al. 2004]. Moreover, a number of guidelines [Geneva: WHO, 2010; ACSM's Exercise for Older Adults, 2011] recommend that older people, aged over 65, perform at least 150 minutes per week of medium-intensity aerobic activity (where aerobic activity refers to different activities, such as example: walking, cycling, etc.). Elderly subjects undergoing rehabilitation should be physically active to the extent granted by disability and health status [Geneva: WHO, 2010].
Contrary to this, patients post-surgery of femur fracture perform low levels of physical activity. In fact patients spend at least 98% of the day during the rehabilitation period in a sitting or lying down position in the bed [Davenport et al. 2015]. On average, these patients take 36 steps a day, which results in less than the 2,000-9,000 steps needed to stay healthy [Tudor-Locke et al. 2009]. Indeed deconditioning can be consider a major determining factor for the unsatisfactory recovery of motor skills for patients undergoing femoral surgery during rehabilitation [Davenport et al. 2015].
There is irrefutable evidence showing the beneficial effects of exercise in both prevention and treatment of several diseases. A lot of studies have shown that both men and women who report increased levels of physical activity and fitness have reductions in relative risk of death (by about 20%-35%) [Macera et al. 2003]. The benefits of exercise are evident, not only in healthy persons but also in patients.
Unfortunately, it is hardly conceivable that these patients could reach, in a hospitalization regime, activity levels equal to those recommended by the guidelines. For all these reasons, we have introduced aerobic training performed with an arm cycle ergometer, in patients hospitalized and subjected to conventional rehabilitation.
The primary purpose of this randomized controlled clinical trial is to verify the feasibility of an aerobic exercise program in subjects with recent proximal femur fracture treated surgically.
The secondary purpose is to verify whether the addition of aerobic activity can increase motor performance compared to a program in which no aerobic activity is foreseen. In particular, we expect the patients belonging to the intervention group to walk faster than those who have performed only conventional physiotherapy treatment.
日期
最后验证: | 03/31/2019 |
首次提交: | 07/16/2019 |
提交的预估入学人数: | 07/17/2019 |
首次发布: | 07/18/2019 |
上次提交的更新: | 07/17/2019 |
最近更新发布: | 07/18/2019 |
实际学习开始日期: | 02/12/2019 |
预计主要完成日期: | 07/31/2020 |
预计完成日期: | 12/30/2020 |
状况或疾病
干预/治疗
Other: Conventional rehabilitation
Other: Aerobic exercise
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Conventional rehabilitation Conventional rehabilitation treatment for inpatients with femur fracture | |
Active Comparator: Aerobic exercise Addition of cycle ergometer for upper limb to conventional rehabilitation treatment for femur fracture | Other: Aerobic exercise 30 min/day of aerobic exercise with arm cycle ergometer added to 1h/day for 5 days/week of conventional rehabilitation for femur fracture |
资格标准
有资格学习的年龄 | 65 Years 至 65 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: 1. Older men or women aged 65 years and older (with no upper age limit). 2. An intertrochanteric fracture, AO Type 31-A (Muller Classification), confirmed with hip radiographs, surgically repaired by internal fixation. 3. Low energy fracture (defined as a fall from standing height). 4. No other major trauma. 5. Admission to the rehabilitation clinic from 8 to 12 days after the surgery 6. Patients autonomous prior to fracture. 7. Provision of informed consent by patient. Exclusion Criteria: 1. Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip) or upper extremity (i.e., radius, ulna or humerus fracture). 2. Orthopedic contraindications to mobilization and to lower extremity operated load; 3. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia). 4. Patients with neurological diseases. 5. Patients with important cardiac diseases. 6. Patients with a pathologic fracture. 7. Patients with subtrochanteric fracture or with a fracture AO Type 31-B or 31-C (Muller Classification). 8. Patients with a previous history of frank dementia. 9. Terminally-ill (life expectation < 6 months). 10. Patients who lived in an institution before the fracture event or were not self-sufficient. |
结果
主要结果指标
1. Analysis of feasibility [Up to 4 weeks]
次要成果指标
1. Timed Up and Go (TUG) test [Up to 4 weeks]
2. 10-meter Walking Test (10mWT) [Up to 4 weeks]
3. Cumulated Ambulation Score - Italian version (CAS-I) [Up to 4 weeks]
4. Activities-Specific Balance Confidence Scale - 5 levels (ABC 5-levels) [Up to 4 weeks]
5. Maximum isometric force of the knee extensors [Up to 4 weeks]
6. Verbal Ranking Scale (VRS) [Up to 4 weeks]