Effectiveness of Community-Based Physiotherapy Versus General Practice

Not Applicable

Completed

• Conditions: Chronic Disorders
• Interventions: Other: Multimodal community program; Procedure: general practice in primary care and education

• Registration Number: NCT01172483
• Lead Sponsor: University of Malaga

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-28
• Study First Posted: 2010-07-29
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2017-03
• Last Update Submitted: 2019-09-28
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multimodal community program	Multimodal community program	multimodal community program of exercise and education
active control	general practice in primary care and education	general practice in primary care and education of chronic disorders

Primary Outcome Measures

Name	Time	Method
International Physical activity Questionnaire	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 Outcome Measures

Name	Time	Method
Saint George questionnaire	SGQ
Roland Morris Questionnaire	RMQ
PIPER CANCER-RELATED FATIGUE	Piper Fatigue Scale-Revised (PFS-R)	The Piper Fatigue Scale-Revised (PFS-R). This 22-item self-report questionnaire asks respondents to rate their fatigue from 0 ("no fatigue") to 10 ("extreme") in 4 different domains: behavioral/severity, affective meaning, sensory and cognitive/mood.
Barthel Index	BI
WOMAC questionnaire	WOMAC
Neck Disability Index	NDI
Fibromyalgia Impact Questionnaire	FIQ
Minnesota living with heart failure questionnaire	MLHFQ

Trial Locations

Locations (1)

Patronato Municipal de deportes de Torremolinos; 🇪🇸 Torremolinos, Malaga, Spain