Metabolic Risk Management, Physical Exercise and Lifestyle Counselling in Low-active Adults; Controlled Randomized Trial

Summary

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.

Conditions

• Metabolic Syndrome X
• Lifestyle-related Condition
• Lifestyle Risk Reduction
• Cardiovascular Risk Factor

Interventions

BEHAVIORAL

Lifestyle

The counselling program consists of 6 group meetings of 1 hour and 3 individual consultations of at least 15 minutes each. Sessions will be set up with the aim to enhance knowledge and empowerment related to physical activity, sedentary conducts, dietary habits, as well as strategies for behaviour change will be given. Individual consultations will focus on establishing realistic objectives and to involve the participants in taking decisions.

BEHAVIORAL

Aerobic interval training

The supervised aerobic interval training will consist of 16 supervised group training lessons lasting 60 minutes and 32 individual nonsupervised training lessons that would be self-administered by each participant. The main part of the training lessons will consist of 4 series of 4 minutes of cycling at a heart rate of 80% of the VO2peak interspersed with active pauses of 2 minutes at 60% of the VO2peak .

BEHAVIORAL

Traditional continous training

The supervised traditional continous training will consist of 16 supervised group training lessons lasting 60 minutes and 32 individual nonsupervised training lessons that would be self-administered by each participant. The main part of the training lessons will consist of activities such as walking, cycling, or tonification exercises always at an intensity of 60% of the VO2peak.

Sponsors & Collaborators

• Institut Català de la Salut

  collaborator OTHER

• Universitat de Lleida

  collaborator OTHER

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  collaborator OTHER

• INEFC-Lleida

  lead OTHER

Principal Investigators

• Assumpta Ensenyat, MD, PhD · INEFC-Lleida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

52 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2017-06-30

Completion

2017-12-31

Countries

• Spain

Study Locations