We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00714831
Recruitment Status : Unknown
Verified July 2008 by Jordi Gol i Gurina Foundation.
Recruitment status was:  Not yet recruiting
First Posted : July 14, 2008
Last Update Posted : July 14, 2008
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Sedentary General Population Behavioral: Physical activity intervention Behavioral: Health educational program

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Referral From Primary Health Care Centers to a Physical Activity Program: Establishing Long-Term Adherence? A Randomized Controlled Trial
Study Start Date : September 2008
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: CG
Control Group
Behavioral: Health educational program
Health education sessions and stretching sessions
Experimental: IG
Intervention Group
Behavioral: Physical activity intervention
3-months physical activity intervention

Outcome Measures

Primary Outcome Measures :
  1. 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. [ Time Frame: baseline-3-6-12-18 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714831

Contact: Maria Giné-Garriga, MS +34 675785983 mgine.pbcn@ics.scs.es
Contact: Carme Martin-Borràs, MS +34 932594338 cmartinb.bcn.ics@gencat.cat

Primary Health Care Not yet recruiting
Barcelona, Spain, 08022
Contact: Maria Giné-Garriga, MS    +34 675785983    mgine.pbcn@ics.scs.es   
Principal Investigator: Maria Giné-Garriga, MS         
Principal Investigator: Carme Martin-Borràs, MS         
Sub-Investigator: Carlos Martin, PhD, MD         
Sub-Investigator: Anna Puig-Ribera, PhD         
Sub-Investigator: Juan José Anton, MD         
Sub-Investigator: Agustí Guiu, MD         
Sub-Investigator: Ana Cascos, Nurse         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Unitat de Suport a la Recerca, Barcelona, Spain
Catalan Society of Family Medicine
Study Director: Carlos Martin, PhD, MD Primary Health Care of Barcelona