Skip to main content
Clinical Trials/NCT01172483
NCT01172483
Completed
Not Applicable

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

University of Malaga1 site in 1 country220 target enrollmentDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Disorders
Sponsor
University of Malaga
Enrollment
220
Locations
1
Primary Endpoint
International Physical activity Questionnaire
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
March 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Antonio I Cuesta-Vargas

PhD

University of Malaga

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

International Physical activity Questionnaire

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials