Effectiveness of Community-Based Physiotherapy Versus General Practice (ECACOM)
Primary Purpose
Chronic Disorders
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
general practice in primary care and education
Multimodal community program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Disorders focused on measuring primary care, physical and aquatic exercises, promotion physical activity, chronic disorders
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.
Sites / Locations
- Patronato Municipal de deportes de Torremolinos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
multimodal community program
active control
Arm Description
multimodal community program of exercise and education
general practice in primary care and education of chronic disorders
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Fibromyalgia Impact Questionnaire
Minnesota living with heart failure questionnaire
Saint George questionnaire
Barthel Index
WOMAC questionnaire
Neck Disability Index
Roland Morris Questionnaire
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.
Full Information
NCT ID
NCT01172483
First Posted
July 28, 2010
Last Updated
September 28, 2019
Sponsor
University of Malaga
Collaborators
Andaluz Health Service
1. Study Identification
Unique Protocol Identification Number
NCT01172483
Brief Title
Effectiveness of Community-Based Physiotherapy Versus General Practice
Acronym
ECACOM
Official Title
Effectiveness of Community-Based Physiotherapy in Chronic Disorders Versus General Practice in Primary Care. Multicenter Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga
Collaborators
Andaluz Health Service
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disorders
Keywords
primary care, physical and aquatic exercises, promotion physical activity, chronic disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Education & exercise
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
multimodal community program
Arm Type
Experimental
Arm Description
multimodal community program of exercise and education
Arm Title
active control
Arm Type
Active Comparator
Arm Description
general practice in primary care and education of chronic disorders
Intervention Type
Procedure
Intervention Name(s)
general practice in primary care and education
Intervention Description
education of chronic disorders in PC
Intervention Type
Other
Intervention Name(s)
Multimodal community program
Other Intervention Name(s)
8-week programme of MultiModal Physiotherapy Program combined with Deep water running exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
International Physical activity Questionnaire
Description
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.
Time Frame
IPAQ
Secondary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire
Time Frame
FIQ
Title
Minnesota living with heart failure questionnaire
Time Frame
MLHFQ
Title
Saint George questionnaire
Time Frame
SGQ
Title
Barthel Index
Time Frame
BI
Title
WOMAC questionnaire
Time Frame
WOMAC
Title
Neck Disability Index
Time Frame
NDI
Title
Roland Morris Questionnaire
Time Frame
RMQ
Title
PIPER CANCER-RELATED FATIGUE
Description
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.
Time Frame
Piper Fatigue Scale-Revised (PFS-R)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio I Cuesta-Vargas, PhD
Organizational Affiliation
University of Malaga
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josefa Sanpedro, PhD
Organizational Affiliation
Andalusian Health Service
Official's Role
Study Director
Facility Information:
Facility Name
Patronato Municipal de deportes de Torremolinos
City
Torremolinos
State/Province
Malaga
ZIP/Postal Code
29620
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23399032
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.
Results Reference
derived
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Effectiveness of Community-Based Physiotherapy Versus General Practice
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