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Completed

NCT Number: NCT01172483

Effectiveness of Community-Based Physiotherapy Versus General Practice

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Patronato Municipal de deportes de Torremolinos

Torremolinos, Malaga, 29620, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

general practice in primary care and education

Procedure

education of chronic disorders in PC

Multimodal community program

Other

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

Primary outcomes

  1. International Physical activity Questionnaire

    Time frame: 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 outcomes

  1. Fibromyalgia Impact Questionnaire

    Time frame: FIQ

  2. Minnesota living with heart failure questionnaire

    Time frame: MLHFQ

  3. Saint George questionnaire

    Time frame: SGQ

  4. Barthel Index

    Time frame: BI

  5. WOMAC questionnaire

    Time frame: WOMAC

  6. Neck Disability Index

    Time frame: NDI

  7. Roland Morris Questionnaire

    Time frame: RMQ

  8. PIPER CANCER-RELATED FATIGUE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Collaborators

  • Andaluz Health Service

Registry information

Official study title

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

Acronym: ECACOM

Important dates

Study start
2009
Primary completion
2013
Study completion
2017
First posted
Jul 29, 2010
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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