Chronic DisordersECACOMNCT01172483
Effectiveness of Community-Based Physiotherapy Versus General Practice
A study testing general practice in primary care and education and Multimodal community program in people with Chronic Disorders, run by University of Malaga at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Disorders
- What is being tested?
- general practice in primary care and education and Multimodal community program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2009to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Patronato Municipal de deportes de Torremolinos
Torremolinos, Malaga, 29620
About this study
Official title: 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.
- Conditions
- Chronic Disorders
- Being tested
- general practice in primary care and education, Multimodal community program
- Keywords
- primary care, physical and aquatic exercises, promotion physical activity, chronic disorders
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general practice in primary care and educationProcedure or surgery
education of chronic disorders in PC
Multimodal community programOther
Also called 8-week programme of MultiModal Physiotherapy Program combined with Deep water running exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| multimodal community program | Experimental | multimodal community program of exercise and education Receives: Other: Multimodal community program |
| active control | Active comparator | general practice in primary care and education of chronic disorders Receives: Procedure: general practice in primary care and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: IPAQ
Secondary outcomes (8)
Fibromyalgia Impact Questionnaire
Measured: FIQ
Minnesota living with heart failure questionnaire
Measured: MLHFQ
Saint George questionnaire
Measured: SGQ
Barthel Index
Measured: BI
WOMAC questionnaire
Measured: WOMAC
Neck Disability Index
Measured: NDI
Roland Morris Questionnaire
Measured: 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.
Measured: Piper Fatigue Scale-Revised (PFS-R)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2013
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Education \& exercise
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Andaluz Health Service
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
- Investigators
- Antonio I Cuesta-Vargas, PhD, Principal investigator, University of MalagaJosefa Sanpedro, PhD, Study director, Andalusian Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172483
- Sponsor's protocol ID
- 04-2009
- Acronym
- ECACOM
- Status last verified
- Jan 2013
- First submitted
- 28 Jul 2010
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23399032
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Community-Based Physiotherapy in Chronic Disorders Versus General Practice in Primary Care. Multicenter Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01172483
- Acronym / sponsor ID
- ECACOM / 04-2009
- Conditions
- Chronic Disorders
- Keywords
- primary care, physical and aquatic exercises, promotion physical activity, chronic disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Andaluz Health Service
- Study start
- Dec 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Education \& exercise
| Arm | Type | Receives |
|---|---|---|
| multimodal community program | Experimental | Other: Multimodal community programmultimodal community program of exercise and education |
| active control | Active comparator | Procedure: general practice in primary care and educationgeneral practice in primary care and education of chronic disorders |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| general practice in primary care and educationeducation of chronic disorders in PC | Procedure or surgery | active control |
| Multimodal community programAlso: 8-week programme of MultiModal Physiotherapy Program combined with Deep water running exerciseThe 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 | multimodal community program |
Primary outcome
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.
8 secondary outcomes
Fibromyalgia Impact Questionnaire
Time frame: FIQ
Minnesota living with heart failure questionnaire
Time frame: MLHFQ
Saint George questionnaire
Time frame: SGQ
Barthel Index
Time frame: BI
WOMAC questionnaire
Time frame: WOMAC
Neck Disability Index
Time frame: NDI
Roland Morris Questionnaire
Time frame: RMQ
PIPER CANCER-RELATED FATIGUE
Time frame: Piper Fatigue Scale-Revised (PFS-R)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Derived from this study: PubMed 23399032Martin-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio I Cuesta-Vargas, PhD principal investigator
University of Malaga
Josefa Sanpedro, PhD study director
Andalusian Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing general practice in primary care and education and Multimodal community program in people with Chronic Disorders, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Physical activity Questionnaire (time frame: IPAQ). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01172483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.