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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disorders
• Intervention / Treatment: Other: Multimodal community program; Procedure: general practice in primary care and education

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Malaga
    • Torremolinos, Malaga, Spain, 29620
      • Patronato Municipal de deportes de Torremolinos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multimodal community program; multimodal community program of exercise and education	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.; Other Names: 8-week programme of MultiModal Physiotherapy Program combined with Deep water running exercise
Active Comparator: active control; general practice in primary care and education of chronic disorders	Procedure: general practice in primary care and education; education of chronic disorders in PC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibromyalgia Impact Questionnaire		FIQ
Minnesota living with heart failure questionnaire		MLHFQ
Saint George questionnaire		SGQ
Barthel Index		BI
WOMAC questionnaire		WOMAC
Neck Disability Index		NDI
Roland Morris Questionnaire		RMQ
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)

Collaborators and Investigators

• Sponsor: University of Malaga
• Collaborators: Andaluz Health Service
• Investigators: Principal Investigator: Antonio I Cuesta-Vargas, PhD, University of Malaga; Study Director: Josefa Sanpedro, PhD, Andalusian Health Service

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: July 28, 2010
• First Submitted That Met QC Criteria: July 28, 2010
• First Posted (Estimate): July 29, 2010

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 28, 2019
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: primary care; chronic disorders; physical and aquatic exercises; promotion physical activity
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 04-2009