The Effect of Exercise Training on Individuals With Osteoporotic Vertebral Fractures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain Assessment
研究概览
简要总结
Physiotherapy has an important place in the treatment of osteoporotic vertebral fractures. Therapeutic exercise is often recommended for patients with vertebral fractures to reduce pain and restore functional movement. There is not enough evidence in the literature to determine the effects of long-term exercise on osteoporotic fractures and their side effects.
Therefore, the aim of this study is to evaluate the effectiveness of 12-week exercise training in patients with osteoporotic vertebral fractures.
详细描述
Osteoporotic vertebral fractures are associated with increased morbidity (eg, pain, poor quality of life) and mortality. Therapeutic exercise is a conservative non-pharmacological treatment that is often recommended for patients with vertebral fractures to reduce pain and restore functional movement.
There are preliminary studies showing that exercise may have an important role in improving quality of life and reducing the risk of re-fracture in these individuals. There are several reports of pain relief after short-term (6-10 weeks) exercise programs in people with spinal fractures, suggesting that there is uncertainty in the effects reported after longer-term (12-24 weeks) exercise. Data are scarce and there are only four studies examining this question, and one is a multi-component physical therapy intervention that includes exercise. Not all studies have examined individuals with severe pain at baseline. The quality assessment of the evidence for the effects of exercise on pain is very low.
There is insufficient evidence in the literature to determine the effects of exercise on osteoporotic fractures and their side effects.
Therefore, the aim of the study is to evaluate the effectiveness of 12-week resistance and balance exercises in patients with osteoporotic vertebral fractures.The group of patients who will exercise will be compared with individuals who do not receive any treatment or exercise.
It is aimed to reveal the effects of exercise on pain, physical performance, quality of life, depression, loss of function, kinesiophobia and sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory,
- •55 years and over,
- •A minimum pain score of 3 in the Short Form Mc-Gill, which we will use for pain assessment.
- •Able to use mobile phone by himself or with the support of his family,
- •Having at least one vertebral fracture at least 6 months ago as a result of X-ray,
- •It was defined as having osteoporosis (Lumbar spine DEXA T score <-2.5).
排除标准
- •Metabolic disease that will prevent participation in exercise,
- •Pain at a level that prevents participation in exercise (a score above 7 in Short Form Mc Gill)
- •Severe cardiovascular or pulmonary diseases (such as Uncontrolled Hypertension, resting heart rate 100 beats/min),
- •Psychiatric diseases
- •Determined as a recent fracture history
结局指标
主要结局
Pain Assessment
时间窗: within 1 week of study completion (average 12 weeks)
The assessment of low back pain will be performed with the Short Form McGill Pain Scale. The form consists of three parts. In the first part, there are 15 descriptive word groups. Of these, 11 evaluate the sensory dimension of the pain, and 4 evaluate the perceptual dimension. These descriptors are rated on an intensity scale from 0 to 3 (0= none, 1= Mild, 2=Moderate, 3= Excess). In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. In the second part of the form, there are five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. In the third part, the current pain intensity of the patient is evaluated using a visual comparison scale.
次要结局
- Physical Performance Assessment(within 1 week of study completion (average 12 weeks))
- Kinesiophobia Assessment(within 1 week of study completion (average 12 weeks))
- Sleepiness State Assessment(within 1 week of study completion (average 12 weeks))
- Sleep Quality Assessment(within 1 week of study completion (average 12 weeks))
- Quality of Life Assessment(within 1 week of study completion (average 12 weeks))
- Depression Assessment(within 1 week of study completion (average 12 weeks))
- Loss of Function Assessment(within 1 week of study completion (average 12 weeks))
研究者
Yasemin Salkin
LECTURER
Hasan Kalyoncu University