Cardiovascular Risk Factor Clinical Trial
Official title:
Supervised Physical Exercise and Lifestyle Counselling in the Management of Metabolic Risk in Low-active Adults; a Controlled Randomized Trial. Belluga't de CAP a Peus
The purpose of this study is evaluate the effectiveness of different doses of supervised
exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care
intervention tool for the management of the metabolic syndrome in low active adults with one
or more metabolic risk factors.
Secondary aims of the study are to investigate the effects of these interventions on systemic
inflammation and adipose tissue function, cardiorespiratory fitness, physical activity and
sedentary habits, and the cost-effectiveness of the intervention with regard to health
related quality of life.
The general hypothesis is that adults with risk factors for metabolic syndrome participating
in interventions for the promotion of a healthy lifestyle that together with counselling
strategies will include supervised physical exercise of vigorous intensity will present
greater improvements in terms of metabolic risk, physical condition, physical
activity/sedentary behaviours and psychological parameters at the end of the intervention and
at 6-months follow-up than participants in interventions for the promotion of a healthy
lifestyle that will include counselling plus physical exercise of low-to-moderate intensity
or interventions based exclusively on counselling.
It is a three arms controlled randomized clinical trial implemented in the Primary Health
Care setting and of 10 months duration.
The purpose of this study is evaluate the effectiveness of different doses of supervised
exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care
intervention tool for the management of the metabolic syndrome in low active adults with one
or more metabolic risk factors.
Secondary aims of the study are to investigate the effects of these interventions on systemic
inflammation and adipose tissue function, cardiorespiratory fitness, physical activity and
sedentary habits, and the cost-effectiveness of the intervention with regard to health
related quality of life.
The general hypothesis is that adults with risk factors for metabolic syndrome participating
in interventions for the promotion of a healthy lifestyle that together with counselling
strategies will include supervised physical exercise of vigorous intensity will present
greater improvements in terms of metabolic risk, physical condition, physical
activity/sedentary behaviours and psychological parameters at the end of the intervention and
at 6-months follow-up than participants in interventions for the promotion of a healthy
lifestyle that will include counselling plus physical exercise of low-to-moderate intensity
or interventions based exclusively on counselling.
It is a three arms controlled randomized clinical trial implemented in the Primary Health
Care setting and of 10 months duration.
Adults aged 30 to 52 years with metabolic risk factors will be randomized in three
intervention groups that will be given one of the following: assessment on healthy lifestyle
plus high intensity physical exercise supervision (3 individual and 6 group sessions + 16
supervised training lessons); assessment plus low-to-moderate intensity physical exercise
supervision (3 individual and 6 group sessions + 16 supervised training lessons) or
assessment-based programme without physical exercise supervision (3 individual and 6 group
sessions).
The main output variables evaluated will be: a) risk factors for the metabolic syndrome
(waist circumference, blood pressure, and plasma triglycerides, high density lipoproteins and
glucose), systemic inflammation and adipose tissue functionality, physical activity habits
and sedentary conducts, dietary habits, quality of life related to health, self-efficacy and
empowerment. The economic cost will also be analysed to determine the cost-effectiveness of
the program. These variables will be assessed 3 times alongside the study: at baseline, at
the end of the 4 months intervention, and at 6 months follow-up. It has been estimated to
recruit 33 participants per group, which are 100 participants.
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