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ExercisePhase 3NCT00131079

PEPAF: Evaluation of Family Physician's Effectiveness for Physical Activity Promotion

A Phase 3 study testing Experimental Programme for Physical Activity Promotion in people with Exercise and Physical Fitness, run by Basque Health Service.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The potential health gains from active lifestyles are very well-known and it is recommended that all adults dedicate at least 30 minutes to activities of at least moderate intensity at least five days a week. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Exercise, Physical Fitness, Quality of Life
What is being tested?
Experimental Programme for Physical Activity Promotion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,317 participants
Where
No sites listed yet
Study dates
Oct 2003to Mar 2006
Phase
Phase 3
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sedentary people who visit the general practitioner for any reason (those who do not dedicate at least 30 minutes to activities of at least moderate intensity at least five days a week).

Who cannot join

  • Disorders of the cardiovascular system
  • Transplant recipients
  • Renal or hepatic failure
  • Severe chronic obstructive pulmonary disease
  • Severe mental disorders
  • Chronic and acute severe infections
Show all 10Show fewer
  • Metabolic uncontrolled disorders
  • Restrictive pathology of muscles, bones and joints
  • Complicated pregnancy
  • Contact difficulties

About this study

Official title: Multi-center Evaluation of the Experimental Program for Physical Activity Promotion (PEPAF), Carried Out by Family Physicians

The potential health gains from active lifestyles are very well-known and it is recommended that all adults dedicate at least 30 minutes to activities of at least moderate intensity at least five days a week. What is still not known is how to help sedentary people follow this recommendation, by means of brief interventions feasible in routine general practice. This multi-center study was designed to evaluate the effectiveness of a physical activity promotion program (called PEPAF) implemented in 56 general practices of the Spanish public primary health care system. The study will test the capacity of the program to increase the physical activity level, physical fitness and health related quality of life of sedentary people.

Read the detailed description

Despite sedentary behavior being one of the strongest risk factors for chronic diseases and mortality, most of the population remains sedentary and evidence is inconclusive that counseling adults in the primary care setting to increase physical activity is effective.

The OBJECTIVE of this randomized clinical trial was to evaluate the effectiveness of an innovative programme to promote physical activity (called PEPAF) implemented by family doctors into daily routine practice. Doctors randomly allocated to the PEPAF group identified sedentary people who visited them for any reason, diagnosed their stage of change and prescribed a written plan of physical activity with those patients ready to change. Those not prepared to change were briefly counseled and given printed materials to motivate them. Patients with cardiovascular disease or other problems meaning that exercise could cause adverse effects were excluded.

Participating people will be followed for 24 months to measure the increase in the level of physical activity from baseline measurement to 6, 12 and 24 months, using 7-day physical activity recall. Health-related quality of life and cardiorespiratory fitness (submaximal cycle ergometer test) will also be measured.

People assigned to the PEPAF group will be COMPARED to patients of family doctors randomly assigned to the control group in which any systematic intervention on physical activity promotion has been postponed until year 2006, except for those patients whose health problems were directly related to a sedentary lifestyle. The average changes observed in the two groups will be compared, on the basis of intention to treat through analysis of covariance. The investigators will use mixed-effect models to take into account intra-patient, intra-doctor and intra-center correlation.

Being tested
Experimental Programme for Physical Activity Promotion, Control
Keywords
Primary Health Care, Physicians, Family, Family Practice, Health Promotion, Randomized Controlled Trials, Multicenter Studies, Physical Fitness, Quality of Life
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental Programme for Physical Activity PromotionBehavioural

    General practitioner's (GP) physical activity (PA) assessment and advise using a web-based software that prompted open questions to elicit believes about benefits of PA, graphical information about risks of inactivity and examples of type sentences to provide medical advise.

    Educational materials summarizing benefits, risks and motivation.

    Prescription: 15 minutes educational session in which GP negotiated a goal, addressed possible barriers and anticipated solutions using web-based tools for lack of time, community resources, and health problems. Finally, they designed a 3-month PA activity plan that derived in a standardized printed prescription of frequency, duration, intensity and progression of a selected PA or exercise that included a self-monitoring log.

  • ControlBehavioural

    Control general practitioners assessed physical activity and performed recruitment in a similar way but offered usual care

Study groups in NCT00131079
Study groupRoleWhat they receive
PEPAFExperimentalGeneral Practitioner's assessment of physical activity level and minimal advice in routine clinical practice supplemented by physical activity prescription to those who accepted an additional 15 minutes appointment.
Receives: Behavioral: Experimental Programme for Physical Activity Promotion
ControlActive comparatorNot described
Receives: Behavioral: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical activity level (7-day Physical Activity Recall [PAR])

    Measured: six months from the start of the intervention

Secondary outcomes (2)

  1. Cardiorespiratory fitness

    Measured: six months from the start of the intervention

  2. Health related quality of life (SF-36)

    Measured: six months from the start of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2005 (estimated)
  2. Study startOct 2003
  3. Study completionMar 2006

Resources

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 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,317 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00131079
Sponsor's protocol ID
PI020015-G03/170
Other IDs
PI020015, G03/170
Status last verified
Oct 2007
First submitted
16 Aug 2005
Last updated
21 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • Grandes G, Sanchez A, Torcal J, Ortega Sanchez-Pinilla R, Lizarraga K, Serra J; Grupo PEPAF. [Protocol for the multi-centre evaluation of the Experimental Programme Promotion of Physical Activity (PEPAF)]. Aten Primaria. 2003 Nov 15;32(8):475-80. doi: 10.1016/s0212-6567(03)79318-4. Spanish.

    PubMed 14636505

  • Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003180. doi: 10.1002/14651858.CD003180.pub2.

    PubMed 15674903

  • Eden KB, Orleans CT, Mulrow CD, Pender NJ, Teutsch SM. Does counseling by clinicians improve physical activity? A summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2002 Aug 6;137(3):208-15. doi: 10.7326/0003-4819-137-3-200208060-00015.

    PubMed 12160371

  • Lopez-de-Munain J, Torcal J, Lopez V, Garay J. Prevention in routine general practice: activity patterns and potential promoting factors. Prev Med. 2001 Jan;32(1):13-22. doi: 10.1006/pmed.2000.0777.

    PubMed 11162322

  • U. S. Department of Health and Human Services. Physical Activity and Health: a report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, 1996.

  • Grandes G, Cortada JM, Arrazola A, Laka JP. Predictors of long-term outcome of a smoking cessation programme in primary care. Br J Gen Pract. 2003 Feb;53(487):101-7.

    PubMed 12817354

  • Grandes G, Cortada JM, Arrazola A. An evidence-based programme for smoking cessation: effectiveness in routine general practice. Br J Gen Pract. 2000 Oct;50(459):803-7.

    PubMed 11127170

  • Grandes G, Sanchez A, Montoya I, Ortega Sanchez-Pinilla R, Torcal J; PEPAF Group. Two-year longitudinal analysis of a cluster randomized trial of physical activity promotion by general practitioners. PLoS One. 2011 Mar 29;6(3):e18363. doi: 10.1371/journal.pone.0018363.

    PubMed 21479243

  • Grandes G, Sanchez A, Sanchez-Pinilla RO, Torcal J, Montoya I, Lizarraga K, Serra J; PEPAF Group. Effectiveness of physical activity advice and prescription by physicians in routine primary care: a cluster randomized trial. Arch Intern Med. 2009 Apr 13;169(7):694-701. doi: 10.1001/archinternmed.2009.23.

    PubMed 19364999

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Experimental Programme for Physical Activity Promotion in people with Exercise and Physical Fitness, run by Basque Health Service.

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 1 inclusion and 10 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: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity level (7-day Physical Activity Recall [PAR]) (time frame: six months from the start of the intervention). 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 NCT00131079, which also lists 9 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 21 Mar 2018.

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