Sedentary General PopulationNCT00714831
Referral From Primary Health Care Centers to a Physical Activity Program. A Randomized Controlled Trial
A study testing Physical activity intervention and Health educational program in people with Sedentary General Population, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedentary General Population
- What is being tested?
- Physical activity intervention and Health educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2008to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of both gender.
- Low physical activity level assessed with International Physical Activity Questionnaire.
- Able to walk and stand up from a chair unaided.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Primary Health Care
Barcelona, 08022
Maria Giné-Garriga, MS, +34 675785983, mgine.pbcn@ics.scs.es
Maria Giné-Garriga, MS
About this study
Official title: Referral From Primary Health Care Centers to a Physical Activity Program: Establishing Long-Term Adherence? A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Sedentary General Population
- Being tested
- Physical activity intervention, Health educational program
- Keywords
- Physical activity promotion, Primary health care, Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
3-months physical activity intervention
Health educational programBehavioural
Health education sessions and stretching sessions
| Study group | Role | What they receive |
|---|---|---|
| CG | Active comparator | Control Group Receives: Behavioral: Health educational program |
| IG | Experimental | Intervention Group Receives: Behavioral: Physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline-3-6-12-18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sedentary General PopulationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Unitat de Suport a la Recerca, Barcelona, Spain, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Investigators
- Carlos Martin, PhD, MD, Study director, Primary Health Care of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714831
- Sponsor's protocol ID
- PI081304
- Status last verified
- Jul 2008
- First submitted
- 11 Jul 2008
- Last updated
- 14 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29502081Gine-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.
PubMed 23805219Gine-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.
PubMed 19161605
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Referral From Primary Health Care Centers to a Physical Activity Program: Establishing Long-Term Adherence? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00714831
- Acronym / sponsor ID
- PI081304
- Conditions
- Sedentary General Population
- Keywords
- Physical activity promotion, Primary health care, Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Unitat de Suport a la Recerca, Barcelona, Spain, Societat Catalana de Medicina Familiar i Comunitària, Assoc. (CAMFiC)
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 14 Jul 2008 (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.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CG | Active comparator | Behavioral: Health educational programControl Group |
| IG | Experimental | Behavioral: Physical activity interventionIntervention Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults of both gender.
- Low physical activity level assessed with International Physical Activity Questionnaire.
- Able to walk and stand up from a chair unaided.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Physical activity intervention3-months physical activity intervention | Behavioural | IG |
| Health educational programHealth education sessions and stretching sessions | Behavioural | CG |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2008.
- Derived from this study: PubMed 29502081Martin-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.
- Derived from this study: PubMed 23805219Gine-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.
- Derived from this study: PubMed 19161605Gine-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.
Related trials for Sedentary General Population
RecruitingObservational study
SAPHIR2 : Simplification of PHysical Activity Assessment by Rapid Interrogation
General Population (no Specific Condition or Disease)
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.
Carlos Martin, PhD, MD study director
Primary Health Care of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention and Health educational program in people with Sedentary General Population, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 14 Jul 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Giné-Garriga, MS (+34 675785983, mgine.pbcn@ics.scs.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT00714831, which also lists 3 linked publications.
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 14 Jul 2008.