Clinical trial NCT01172483: Effectiveness of Community-Based Physiotherapy Versus General Practice
Official title: Effectiveness of Community-Based Physiotherapy in Chronic Disorders Versus General Practice in Primary Care. Multicenter Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disorders
Keywords: primary care
physical and aquatic exercises
promotion physical activity
chronic disorders
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Andaluz Health Service
First posted: 2010-07-29
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Education \& exercise
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: International Physical activity Questionnaire
timeFrame: IPAQ
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire
timeFrame: FIQ
measure: Minnesota living with heart failure questionnaire
timeFrame: MLHFQ
measure: Saint George questionnaire
timeFrame: SGQ
measure: Barthel Index
timeFrame: BI
measure: WOMAC questionnaire
timeFrame: WOMAC
measure: Neck Disability Index
timeFrame: NDI
measure: Roland Morris Questionnaire
timeFrame: RMQ
measure: PIPER CANCER-RELATED FATIGUE
timeFrame: Piper Fatigue Scale-Revised (PFS-R)
Other outcomes:
Locations:
city: Torremolinos
country: Spain
facility: Patronato Municipal de deportes de Torremolinos
state: Malaga
Study officials:
affiliation: University of Malaga
name: Antonio I Cuesta-Vargas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Andalusian Health Service
name: Josefa Sanpedro, PhD
role: STUDY_DIRECTOR
References:
citation: Martin-Valero R, Cuesta-Vargas AI, Labajos-Manzanares MT. Effectiveness of the physical activity promotion programme on the quality of life and the cardiopulmonary function for inactive people: randomized controlled trial. BMC Public Health. 2013 Feb 12;13:127. doi: 10.1186/1471-2458-13-127.