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Effectiveness of Community-Based Physiotherapy Versus General Practice (ECACOM)

U

University of Malaga

Status

Completed

Conditions

Chronic Disorders

Treatments

Other: Multimodal community program
Procedure: general practice in primary care and education

Study type

Interventional

Funder types

Other

Identifiers

NCT01172483
04-2009

Details and patient eligibility

About

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.

Enrollment

220 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

220 participants in 2 patient groups

multimodal community program
Experimental group
Description:
multimodal community program of exercise and education
Treatment:
Other: Multimodal community program
active control
Active Comparator group
Description:
general practice in primary care and education of chronic disorders
Treatment:
Procedure: general practice in primary care and education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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