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