Effects of Individually Tailored Home Based Exercise Program with Support Adherence for People with Chronic Low Back Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- (1) Exercise Adherence Rating Scale (EARS)
研究概览
简要总结
Background:
Low back pain affects near about 8% of the world adult population, and the life time prevalence of LBP in India was 66%. The standard practice guidelines to manage LBP and improve function recommends the use of exercise to be effective. Non-adherence to exercises is a challenge for healthcare providers particularly in the physical rehabilitation domains. However, most of the time the effect of the home-based exercise programs is often small, not sustained, and poorly adhered. The extent to which the LBP patients engage and adhere to the home-exercise program has been identified as an important predictor of the efficacy of the management and the prognostic outcome.
The objective of this study is to determine the efficacy of individually tailored exercise program integrated with exercise adherence strategies in improving the LBP patients home exercise engagements (adherence), exercise self-efficacy, and physical function.
Hypothesis;(Ha)
Our hypothesis (Ha) is that the individually tailored home-based LBP exercise program with adherence support interventions will be improving the exercise adherence, exercise self-efficacy, and physical function in comparison with the individually tailored home exercise program without adherence support for LBP patients.
Methods: A single-center, 2-arm parallel group (1:1 allocation) randomized controlled trial using blinded assessment at baseline, 6 weeks, and 12 weeks, will be conducted. All the eligible adult participants with chronic LBP visiting the SRMIST physiotherapy OPD for LBP management will be checked for eligibility to participate in this study. At the time of home exercise prescription, the participants will be either allocated to the tailored home exercise program with the additional exercise adherence support intervention program spread over the 6 weeks or the standard physiotherapy home-exercise program with the follow up at 12 weeks.
**Discussion;**This research will help in the testing the efficacy of the support adherence program for home exercise engagement for the LBP participants, and the effects of good exercise engagement to home-exercise program in improving the physical function and pain among the LBP patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Participants aged 18 and above are included 2 patients who had diagnosed with low back pain more than 3months.
- •3 Patients who are willing to do home exercises with adherence support are mainly included.
排除标准
- •1 Patients without personnel smart phone 2 Impaired hearing & speech 3 Cognitive impairment 4 Women planning for pregnancy 5 Patient who are not willing to sign the informed consent 6 Patient with psychological illness 7 Infectious conditions related to spine, groin, and abdomen.
结局指标
主要结局
(1) Exercise Adherence Rating Scale (EARS)
时间窗: baseline | at 6 weeks | at 12 weeks
(2) Self efficacy for Exercise (SEE) scale
时间窗: baseline | at 6 weeks | at 12 weeks
次要结局
- Roland Morris Disability Questionnaire(Numeric Pain Rating Scale)
研究者
Seeram Harika
SRM college of physiotherapy SRM institute of science and technology