Effectiveness of Community-Based Physiotherapy Versus General Practice

Chronic Disorders Clinical Trial

— ECACOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172483
• Other study ID #: 04-2009
• Status: Completed
• Phase: N/A
• Start date: December 2009
• Est. completion date: March 2017

Study information

• Verified date: January 2013
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2017
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Disorders

Intervention

Procedure:
• general practice in primary care and education
education of chronic disorders in PC

Other:
• Multimodal community program
The intervention was an 8-week programme of MMPP combined with DWR, delivered by physiotherapists in groups of 8 to 10 participants. One-hour sessions were conducted 3 times per week, consisting of DWR and an individualised MMPP of therapeutic exercises combined with education based on cognitive-behavioural principles. Each session was comprised of 30 minutes of land-based exercise followed by 20 minutes of DWR, with an additional 10 minutes of warm-up and cool-down time. Deep water running stimulates running using a flotation device in water levels over head height. During the first two weeks of the intervention, participants undertook a low-intensity adaptation interval to learn proper exercise technique. For the remaining six weeks, participants were instructed to maintain a constant speed to achieve the prescribed HRAT. If experiencing pain while exercising, participants were asked to temporarily reduce intensity and return to target HR as capable.

Locations

Country	Name	City	State
Spain	Patronato Municipal de deportes de Torremolinos	Torremolinos	Malaga

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaga	Andaluz Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Physical activity Questionnaire	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.	IPAQ
Secondary	Fibromyalgia Impact Questionnaire		FIQ
Secondary	Minnesota living with heart failure questionnaire		MLHFQ
Secondary	Saint George questionnaire		SGQ
Secondary	Barthel Index		BI
Secondary	WOMAC questionnaire		WOMAC
Secondary	Neck Disability Index		NDI
Secondary	Roland Morris Questionnaire		RMQ
Secondary	PIPER CANCER-RELATED FATIGUE	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.	Piper Fatigue Scale-Revised (PFS-R)