中文(简体)
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Addition of Aerobic Training to Conventional Rehabilitation After Femur Fracture

只有注册用户可以翻译文章
登陆注册
链接已保存到剪贴板
状态招聘中
赞助商
Istituti Clinici Scientifici Maugeri SpA

关键词

抽象

The primary purpose of this study is to assess the feasibility of an arm cycle ergometer training in subjects with proximal femur fracture surgically treated. The secondary purpose of this randomized controlled clinical trial is to verify whether the addition of aerobic activity can increase motor performance compared to a conventional exercise program in which no aerobic activity is foreseen.

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

Intertrochanteric Fractures

干预/治疗

Other: Conventional rehabilitation

Other: Aerobic exercise

-

手臂组

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
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]

To assess the feasibility, it will be evaluated: The eligibility rate (the total number of patients admitted with femur fractures and screening divided by the total number of patients meeting the criteria). The recruitment rate (the number of patients recruited among those eligible). The subjects' compliance level will be analyzed dichotomously (no compliance <10 sessions, yes compliance ≥ 10 sessions). Rate of patients who lost the evaluation at the end of the treatment and at the follow-up after 100 days. Any negative effects will be recorded and counted. The following types of adverse events will be calculated separately: a) adverse reactions, adverse events, serious adverse events and suspected serious adverse events. Adherence to treatment: the number of sessions in which patients have reached goal 1) of 30 minutes and 2) intensity between 50%-85% HRmax.

次要成果指标

1. Timed Up and Go (TUG) test [Up to 4 weeks]

TUG is a physical functional measure in which subjects are asked to stand up from a chair, walk 3 m to a horizontal line marked with tape on the floor, turn around, walk back and sit down at a comfortable pace (Podsiadlo et al., 1991).

2. 10-meter Walking Test (10mWT) [Up to 4 weeks]

In the 10mWT the time taken by the patient to travel a linear distance of 10 meters will be timed. During the execution of the test the number of supports will also be recorded, so as to secondly calculate the walking speed (speed (m / s) = space (m) / time (s)), the step length (step length (cm) = 1000 / number of steps) and cadence (cadence (steps / min) = number of steps / time (s) * 60) (Hollman et al., 2008).

3. Cumulated Ambulation Score - Italian version (CAS-I) [Up to 4 weeks]

The CAS-I is a 3-item scale assessing activities that characterize the patient's basic mobility skills: 1) getting in and out of bed, 2) sit-to-stand from a chair with armrests and 3) walking indoors with the use of appropriate walking aids. Each activity is assessed on a three-point ordinal scale from 0-2 (0 = Not able to, despite human assistance and verbal cueing, 1 = Able to, with human assistance and/or verbal cueing from one or more persons, 2 = Able to safely, without human assistance or verbal cueing, use of a walking aid allowed) resulting in a total daily CAS score ranging from zero to six. The CAS scale showed to be a potentially valuable score for early prediction of short-term postoperative outcome after hip fracture surgery.

4. Activities-Specific Balance Confidence Scale - 5 levels (ABC 5-levels) [Up to 4 weeks]

The scale led to assessing the confidence of self-reported balance during daily life activities. Each of the 16 items is assigned a score between 0 (no security) and 4 (total security).

5. Maximum isometric force of the knee extensors [Up to 4 weeks]

The maximum isometric force of the knee extensors will be evaluated pre- and post-training with the use of a manual dynamometer (Roy and Doherty, 2004). The patient will be required to perform a sub-maximal contraction in knee extension, followed by four maximal contractions during which the patient is verbally encouraged by the therapist. The evaluation will be performed first on the healthy limb, then on the operated limb, with a 30-second pause between one contraction and the next. The best value of the 4 tests will then be recorded.

6. Verbal Ranking Scale (VRS) [Up to 4 weeks]

Pain related to femoral fracture will be assessed using the Verbal Ranking Scale (VRS). Divided over 5 levels (VRS 0-4: 0 = no pain; 1 = mild; 2 = moderate; 3 = strong; 4 = extreme), it allows to record the maximum pain experienced by the patient in the previous 48 hours in the execution of some functional activities, such as sitting, keeping standing and walking (Leino et al., 2011).

加入我们的脸书专页

科学支持的最完整的草药数据库

  • 支持55种语言
  • 科学支持的草药疗法
  • 通过图像识别草药
  • 交互式GPS地图-在位置标记草药(即将推出)
  • 阅读与您的搜索相关的科学出版物
  • 通过药效搜索药草
  • 组织您的兴趣并及时了解新闻研究,临床试验和专利

输入症状或疾病,并阅读可能有用的草药,输入草药并查看所使用的疾病和症状。
*所有信息均基于已发表的科学研究

Google Play badgeApp Store badge