Effectiveness of Multimodal Circuit Exercises for Chronic Musculoskeletal Pain in Older Adults: a Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Change on disability.
研究概览
简要总结
Analyze the effectiveness of a multimodal circuit exercise program on chronic musculoskeletal pain and disability in older adults.
详细描述
This is a randomized parallel study (two arms) with blinded outcome assessments. The participants' recruitment will be done by a non-probabilistic sampling resulting from invitations to Basic Health Units. The sample size estimation indicated 164 participants. Participants will be allocated, by means of a randomization process, to one of two groups (82 for each group): Experimental Group (multimodal circuit exercise) or Control Group (cycle of multidisciplinary lectures on pain ). The primary outcomes are global chronic pain intensity and global functional disability scores. The secondary outcomes are functional mobility and cardiorespiratory capacity. All analyses will be processed using the RStudio software. The differences will be considered statistically significant when a 2-tailed p-value is less than 5% (p < 0.05). The statistical analysis will follow the intention to treat. Discussion: This study will discuss the effects of multimodal circuit exercise on global chronic pain intensity and global body functional disability scores. The hypothesize is that multimodal exercises will reduce musculoskeletal chronic pain and disability in older adults to the same extent as traditional supervised and structured exercises.
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
- Single (Outcomes Assessor)
盲法说明
Another researcher collaborator (blinded) will be carried out the outcomes investigated.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects from both sexes;
- •Aged 60 or higher;
- •Had a history of chronic pain in at least one synovial joint for more than three months.
排除标准
- •Participants with some types of co-morbidities that may interfere with the research parameters, such as a history of stroke, stenosis of the spinal canal, severe heart disease, fibromyalgia, rheumatoid arthritis;
- •Participants who presented a level of pain between 7 and 10 points on the Numeric Rate Scale (NRS) in any body location;
- •Participants being under psychiatric treatment with sensory deficits (visual, auditory and intellectual)
- •Participants performing any supervised and structured exercise at the moment of study enrollment or six months before.
结局指标
主要结局
Change on disability.
时间窗: Change from Baseline at immediately post-intervention
Will be used the Independence Index in Activities of Daily Living (Katz Index - KI). The total KI score is in the range 0 to 6, whose score 6 represents an independent patient and 0 indicates a highly dependent patient.
Change on pain intensity.
时间窗: Change from Baseline at immediately post-intervention
Will be used the Brief Pain Inventory (BPI). The Brief Pain Inventory (BPI) \[32, 33\]- a multidimensional, easily used questionnaire, aiming to diagnose a patient's chronic pain during the last 24 hours, categorized into 11 questions, scaled from 0 to 10, in which 10 indicates "worst pain imaginable".
次要结局
- Change on functional mobility(Change from Baseline at immediately post-intervention)
- Change on cardiorespiratory capacity.(Change from Baseline at immediately post-intervention)
研究者
Wagner Rodrigues Martins
Professor
University of Brasilia