跳至主要内容
临床试验/NCT01172483
NCT01172483已完成不适用

Effectiveness of Community-Based Physiotherapy in Chronic Disorders Versus General Practice in Primary Care. Multicenter Randomized Control Trial

University of Malaga1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2009年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
1
主要终点
International Physical activity Questionnaire

研究概览

简要总结

Summary: (Objectives and methodology of the project) AIM: To evaluate the clinical effectiveness of Community physiotherapy intervention on chronic diseases (heart disease, chronic obstructive pulmonary disease, back pain, mechanical neck pain, fibromyalgia, osteoarthritis lower limbs, neurological and cancer survivors) and a group of healthy patients cardiovascular risk factors. DESIGN: Randomized, controlled, prospective study. SUBJECTS OF STUDY: Patients with chronic disease go to the Local Sports Torremolinos Center INTERVENTION: Establishment of a control group that give you some advice education care (brief advice) and a group common experimental multimodal program of 12 weeks therapeutic exercise with health education (brief advice). It will follow up complete with ratings pre and post intervention to both groups and follow up at 6 and 12 months for long-term effect through specific questionnaires for each subgroup chronic disease and pain score (visual scale analog), quality of life (EuroQol-5D) and state health general (Short-Form 12, SF-12) VARIABLES: The intervention physical therapy Community. Result: Specific questionnaires for each subgroup, pain (Visual analogue scale), quality of life (EuroQoL) and general health status (SF-12). DATA ANALYSIS: descriptive statistics, measuring central tendency and dispersion of the variables study. Inferential statistics will be made between intervention of key variables and outcome (Chi square, Student t, ANOVA, Mann-Whitney, Wilcoxon, by type and normal variables). Likewise, establish measures of effect size in main outcome variables, by reduction relative risk, absolute risk and odds ratio with their respective confidence intervals.

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 (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The inclusion criteria will be severe cuts of the disease based on functionality and not the dysfunction indicates the severity level higher 20% of the specific questionnaire for each subgroup

排除标准

  • •Common exclusion criteria for subgroups:
  • •"Rejection of the patient to take part in the survey
  • •Processes of infectious, neoplastic, metastasis, osteoporosis, inflammatory arthritis or fractures "Cognitive impairment of any etiology Presence of unstable angina, arrhythmia, unstable, failure of cardiac valvular "Severe hypertension (systolic> 200 or diastolic> 120)
  • •Depressed systolic function at rest (EF less than 50%)
  • •Evidence of exercise-induced ischemia
  • •Evidence of exercise-induced arrhythmias.
  • •Stenotic coronary lesions greater than 50%. Exercise intolerance, or physical activity any cause.

研究组 & 干预措施

multimodal community program

Experimental

multimodal community program of exercise and education

干预措施: Multimodal community program (Other)

active control

Active Comparator

general practice in primary care and education of chronic disorders

干预措施: general practice in primary care and education (Procedure)

结局指标

主要结局

International Physical activity Questionnaire

时间窗: IPAQ

CRAIG, C. L., A. L. MARSHALL, M. SJÖSTRÖM, A. E. BAUMAN, M. L. BOOTH, B. E. AINSWORTH, M. PRATT, U. EKELUND, A. YNGVE, J. F. SALLIS, and P. OJA. International Physical Activity Questionnaire: 12-Country Reliability and Validity. Med. Sci. Sports Exerc., Vol. 35, No. 8, pp. 1381-1395, 2003.

次要结局

  • Saint George questionnaire(SGQ)
  • Roland Morris Questionnaire(RMQ)
  • PIPER CANCER-RELATED FATIGUE(Piper Fatigue Scale-Revised (PFS-R))
  • Barthel Index(BI)
  • WOMAC questionnaire(WOMAC)
  • Neck Disability Index(NDI)
  • Fibromyalgia Impact Questionnaire(FIQ)
  • Minnesota living with heart failure questionnaire(MLHFQ)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Antonio I Cuesta-Vargas

PhD

University of Malaga

研究点 (1)

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