Effect of a Resistance Exercise Program on the Functionality of Individuals With Chikungunya Fever: Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in functionality of upper limbs
研究概览
简要总结
Common symptoms of chikungunya fever are persistent arthritis and arthralgia, such symptoms can lead to impairment in functionality. The objective of this study is to evaluate the efficacy of a resistance exercise protocol on the functionality of individuals with chronic musculoskeletal manifestations of Chikungunya fever. Quality of life, number of painful joints, intensity of pain, number of recurrence of exacerbation and thermography are secondary outcomes that will also be evaluated. The protocol uses elastic resistance to strengthen muscle groups that stabilize the main joints affected by Chikungunya Fever. The sessions will be 2 times a week for 12 weeks. The control group will not be submitted to the intervention during the 12 weeks, being contacted through telephone calls. After the reevaluation at the end of the 12 weeks the control group will perform the same protocol. The sample will be characterized and the effect size and the mean difference will be calculated. Intention-to-treat analysis and rate of adherence will also be calculated.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Chikungunya fever for more than three months
- •Present musculoskeletal symptoms after infection (eg, arthritis or arthralgia)
排除标准
- •Cognitive deficit that compromises the understanding and accomplishment of the protocol (MiniMental<24);
- •Self-reported disease that contraindicates the performance of research procedures (eg, unstable angina);
- •Self-reported diagnosis of neurological disease;
- •Prior self-reported diagnosis of other inflammatory or autoimmune rheumatic diseases or fibromyalgia;
- •Pregnancy;
- •Physical impairment that prevents arrival to the research site or execution of the exercises (eg, use of walking devices);
- •Execution of other physiotherapeutic treatments during the research period;
- •Regular practice of physical exercises in other places during the period of participation in the research.
结局指标
主要结局
Change in functionality of upper limbs
时间窗: Assessed before intervention, in 6 weeks and after the 12-week intervention
Function of upper limb trough specific score of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire with 30 items with responses range from 1(not limited) to 5 (extremely limited) and two optional sections, responses are used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)
Change in functionality through a stair climb test
时间窗: Assessed before intervention, in 6 weeks and after the 12-week intervention
Performance in seconds of the 4 step stair climb test, the longer the time in seconds, the worse the outcome. The normative values mean for healthy women is 10.22 seconds and healthy men is 8.72 seconds
Change in functionality through a walk test
时间窗: Assessed before intervention, in 6 weeks and after the 12-week intervention
Performance in seconds of the 40m Fast-paced Walk Test, the longer the time in seconds, the worse the outcome. The normative values for women between 50´s and 60´s age range are 19,90 to 22,60 seconds, and for men in the same age range between 19,32 and 20,73 seconds.
Change in functionality through a chair stand test
时间窗: Assessed before intervention, in 6 weeks and after the 12-week intervention
Performance in number of time the patient stands in the 30-Second Chair Stand Test, the higher the number of the better the outcome, the mean for women in the 60´s age range is from 11 to 17 times and for men in the same age range is from 12 to 19 times
次要结局
- Change in the intensity of pain: VAS(assessed in every intervention day (twice a week for 12 weeks))
- Number of patients reporting adverse effects(Reported through study completion, an average of 1 year)
- Change in muscle strength(Assessed every two weeks during the 12-week intervention period)
- Change in the number of exacerbation recurrences(assessed through the 12-week intervention period)
- Change in temperature of areas of interest (joints)(assessed before intervention, in 6 weeks and after the 12-week intervention)
- Change in patients global impression of change(assessed before intervention, in 6 weeks and after the 12-week intervention)
- Change in the number of painful joints(assessed before intervention, in 6 weeks and after the 12-week intervention)
- Change of score on the Medical Outcomes Study 36 - Item Short - Form Health Survey questionnaire(assessed before intervention, in 6 weeks and after the 12-week intervention)
研究者
Isabel Lins Neumann
Principal Investigator
Universidade Federal de Pernambuco