NCT00714831

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
424

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 14, 2008

Status Verified

July 1, 2008

Enrollment Period

2 years

First QC Date

July 11, 2008

Last Update Submit

July 11, 2008

Conditions

Sedentary General Population

Keywords

Physical activity promotionPrimary health careAdherence

Outcome Measures

Primary Outcomes (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.

    baseline-3-6-12-18

Study Arms (2)

CG

ACTIVE COMPARATOR

Control Group

Behavioral: Health educational program

IG

EXPERIMENTAL

Intervention Group

Behavioral: Physical activity intervention

Interventions

Physical activity interventionBEHAVIORAL

3-months physical activity intervention

IG
Health educational programBEHAVIORAL

Health education sessions and stretching sessions

CG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults of both gender.
  • Low physical activity level assessed with International Physical Activity Questionnaire.
  • Able to walk and stand up from a chair unaided.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Health Care

Barcelona, 08022, Spain

Location

Related Publications (3)

  • Martin-Borras C, Gine-Garriga M, Puig-Ribera A, Martin C, Sola M, Cuesta-Vargas AI; PPAF Group. A new model of exercise referral scheme in primary care: is the effect on adherence to physical activity sustainable in the long term? A 15-month randomised controlled trial. BMJ Open. 2018 Mar 3;8(3):e017211. doi: 10.1136/bmjopen-2017-017211.

    PMID: 29502081DERIVED

  • Gine-Garriga M, Martin-Borras C, Puig-Ribera A, Martin-Cantera C, Sola M, Cuesta-Vargas A; PPAF Group. The Effect of a Physical Activity Program on the Total Number of Primary Care Visits in Inactive Patients: A 15-Month Randomized Controlled Trial. PLoS One. 2013 Jun 21;8(6):e66392. doi: 10.1371/journal.pone.0066392. Print 2013.

    PMID: 23805219DERIVED

  • Gine-Garriga M, Martin C, Martin C, Puig-Ribera A, Anton JJ, Guiu A, Cascos A, Ramos R. Referral from primary care to a physical activity programme: establishing long-term adherence? A randomized controlled trial. Rationale and study design. BMC Public Health. 2009 Jan 22;9:31. doi: 10.1186/1471-2458-9-31.

    PMID: 19161605DERIVED

Study Officials

  • Carlos Martin, PhD, MD

    Primary Health Care of Barcelona

    STUDY DIRECTOR

Central Study Contacts

Maria Giné-Garriga, MS

CONTACT

+34 675785983mgine.pbcn@ics.scs.es

Carme Martin-Borràs, MS

CONTACT

+34 932594338cmartinb.bcn.ics@gencat.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2008

First Posted

July 14, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

July 14, 2008

Record last verified: 2008-07

Locations

ES(1)