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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Malaga
Sponsor:
Collaborator:
Andaluz Health Service
Information provided by (Responsible Party):
Dr. Antonio I Cuesta-Vargas, University of Malaga
ClinicalTrials.gov Identifier:
NCT01172483
First received: July 28, 2010
Last updated: July 29, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Chronic Disorders
Procedure: general practice in primary care and education
Other: Multimodal community program
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Community-Based Physiotherapy in Chronic Disorders Versus General Practice in Primary Care. Multicenter Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of Malaga:

Primary Outcome Measures:
  • International Physical activity Questionnaire [ Time Frame: IPAQ ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: FIQ ] [ Designated as safety issue: Yes ]
  • Minnesota living with heart failure questionnaire [ Time Frame: MLHFQ ] [ Designated as safety issue: Yes ]
  • Saint George questionnaire [ Time Frame: SGQ ] [ Designated as safety issue: Yes ]
  • Barthel Index [ Time Frame: BI ] [ Designated as safety issue: Yes ]
  • WOMAC questionnaire [ Time Frame: WOMAC ] [ Designated as safety issue: Yes ]
  • Neck Disability Index [ Time Frame: NDI ] [ Designated as safety issue: Yes ]
  • Roland Morris Questionnaire [ Time Frame: RMQ ] [ Designated as safety issue: Yes ]
  • PIPER CANCER-RELATED FATIGUE [ Time Frame: Piper Fatigue Scale-Revised (PFS-R) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: March 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172483

Contacts
Contact: Antonio I Cuesta-Vargas, PhD 0034952137551 acuesta@uma.es
Contact: Javier Millan, Msc 0034952058087 ext 33 javier.millan@ayto.torremolinos.org

Locations
Spain
Patronato Municipal de deportes de Torremolinos Recruiting
Torremolinos, Malaga, Spain, 29620
Contact: Javier Millan, msc    0034952058087 ext 33    javier.millan@pmdt.torremolinos.es   
Principal Investigator: Antonio I Cuesta-Vargas, PhD         
Sponsors and Collaborators
University of Malaga
Andaluz Health Service
Investigators
Principal Investigator: Antonio I Cuesta-Vargas, PhD University of Malaga
Study Director: Josefa Sanpedro, PhD Andalusian Health Service
  More Information

No publications provided by University of Malaga

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Antonio I Cuesta-Vargas, PhD, University of Malaga
ClinicalTrials.gov Identifier: NCT01172483     History of Changes
Other Study ID Numbers: 04-2009
Study First Received: July 28, 2010
Last Updated: July 29, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by University of Malaga:
primary care
physical and aquatic exercises
promotion physical activity
chronic disorders

Additional relevant MeSH terms:
Chronic Disease
Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014