Referral From Primary Health Care Centers to a Physical Activity Program. A Randomized Controlled Trial

Sedentary General Population Clinical Trial

Official title:

Referral From Primary Health Care Centers to a Physical Activity Program: Establishing Long-Term Adherence? A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00714831
• Other study ID #: PI081304
• Status: Not yet recruiting
• Phase: N/A
• First received: July 11, 2008
• Last updated: July 11, 2008
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2008
• Source: Jordi Gol i Gurina Foundation
• Contact: Maria Giné-Garriga, MS
• Phone: +34 675785983
• Email: mgine.pbcn[@]ics.scs.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial Summary

Declining physical activity and the associated rising burden of disease is a major public-health problem and it has long been known that being physically active has positive health effects. The virtual absence of a public health practice infrastructure for the promotion of physical activity at the local level presents a critical challenge to control policy for chronic disease. We aimed to assess the efficacy of a 3-months physical activity program in primary health care to create adherence to physical activity in sedentary individuals.

Description:

Physical inactivity has emerged as an important risk factor for many chronic diseases. The decline in physical activity is a key public health concern.

Objective. The objective of the study is to assess the effectiveness of a 3-months physical activity programme in the primary healthcare centres (HC), combined with community resources and interdisciplinary work, to create adherence to physical activity in sedentary individuals.

Methods. The design of the study is a randomized controlled trial with a randomized selection of the sample. A total of 424 subjects of both sexes, older than 18 years old, with a low physical activity level (IPAQ), independent, with no medical contraindication to practice physical activity, and coming from 8 different HC, will participate in the study. Each subject will be offered to participate voluntarily in a physical activity programme (24 sessions, twice a week, 60 minutes/session). There will be two groups of 15-20 subjects in each HC (a total of 8 HC), randomizing the subjects of the intervention (GI) and control groups (GC). The study will be divided in two phases, and in each phase there will be 16 groups (8 GC and 8 GI).

In the first and last session different parameters will be assessed in all the subjects (GC and GI): (1) quality of life related to health with SF-12 questionnaire, (2) the attitude towards practicing physical activity with Prochaska stage changes, (3) the physical activity level with the reduced version of the IPAQ, (4) health perception with COOP/WONCA questionnaire, and (5) the social support for physical activity with SSPAS. The welfare pressure to the HC of each participant is also registered, during the 6 months previous and after the programme. Subjects of GI will go through the 24 sessions while subjects of GC will go through a health educational program and will be asked to continue with their everyday activities. After 3, 6 and 12 months of the end of the programme, a pursuit by means of a call will be done (IPAQ, SF-12 and SSPAS). After 6 and 12 months of the end of the programme the same call will be used to assess the Prochaska stages.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 424
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults of both gender.

• Low physical activity level assessed with International Physical Activity Questionnaire.

• Able to walk and stand up from a chair unaided.

Exclusion Criteria:

• Recommended contradictions to advising physical activity to older adults.

• Presence of unstable angina.

• Uncontrolled congestive heart failure.

• Unstable arrhythmia or heart valvular disease.

• Progressive or debilitating medical conditions.

• Severe hypertension (systolic = 200, or diastolic = 120).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sedentary General Population

Intervention

Behavioral:
• Physical activity intervention
3-months physical activity intervention
• Health educational program
Health education sessions and stretching sessions

Locations

Country	Name	City	State
Spain	Primary Health Care	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation	Catalan Society of Family Medicine, Unitat de Suport a la Recerca, Barcelona, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity.		baseline-3-6-12-18	No