Effectiveness of Community-Based Physiotherapy Versus General Practice

NCT ID: NCT01172483

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2017-03-31

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.

Conditions

Chronic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

multimodal community program

multimodal community program of exercise and education

Group Type: EXPERIMENTAL

Multimodal community program

Intervention Type: 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.

active control

general practice in primary care and education of chronic disorders

Group Type: ACTIVE_COMPARATOR

general practice in primary care and education

Intervention Type: PROCEDURE

education of chronic disorders in PC

Interventions

general practice in primary care and education

education of chronic disorders in PC

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

Other Intervention Names

8-week programme of MultiModal Physiotherapy Program combined with Deep water running exercise

Eligibility Criteria

Exclusion Criteria

"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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andaluz Health Service

OTHER_GOV

Sponsor Role: collaborator

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Dr. Antonio I Cuesta-Vargas

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio I Cuesta-Vargas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Malaga

Josefa Sanpedro, PhD

Role: STUDY_DIRECTOR

Andalusian Health Service

Locations

Patronato Municipal de deportes de Torremolinos

Torremolinos, Malaga, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 23399032 (View on PubMed)

Other Identifiers

04-2009

Identifier Type: -

Identifier Source: org_study_id