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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Change from baseline in metabolic risc score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 52 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low active (achieving less than 150 minutes/week of moderate-to-vigorous physical activity or have not participated in any supervised exercise programs for at least the last 6 months).
- •Having one or more risk factors for metabolic syndrome (Marcuello et al., 2013) (waist circumference >94.5 cm for men and >89.5 cm for women; blood pressure ≥130/85 mmHg; triglycerides in plasma ≥150 mg/dL; high density lipoprotein cholesterol in plasma <40 mg/dL for men and <50 mg/dL for women; fasting glycaemia ≥100 mg/dL).
- •Accept and sign the written informed consent.
- •Accept the randomized group assignment.
排除标准
- •Couples or individuals living in the same house
- •Morbid obesity (BMI ≥ 40).
- •A past/current history and/or physical examination or laboratory findings of significant diseases of cardiovascular, respiratory, neuromuscular, psychiatric diseases/disorders.
- •Diseases/disorders that may contraindicate performing physical exercise or a stress test.
研究组 & 干预措施
Lifestyle counseling
This group will receive lifestyle counselling but not supervised exercise training sessions
干预措施: Lifestyle (Behavioral)
Aerobic interval training
This group will receive lifestyle counselling plus supervised high intensity (80%VO2max) interval exercise training sessions
干预措施: Lifestyle (Behavioral)
Aerobic interval training
This group will receive lifestyle counselling plus supervised high intensity (80%VO2max) interval exercise training sessions
干预措施: Aerobic interval training (Behavioral)
Traditional continous training
This group will receive lifestyle counselling plus supervised moderate intensity (60%VO2max) continous exercise training sessions
干预措施: Lifestyle (Behavioral)
Traditional continous training
This group will receive lifestyle counselling plus supervised moderate intensity (60%VO2max) continous exercise training sessions
干预措施: Traditional continous training (Behavioral)
结局指标
主要结局
Change from baseline in metabolic risc score
时间窗: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
A continuous metabolic syndrome risk score (cMSSy) will be calculated as described by Wijndaele (Wijndaele et al., 2006). The score contains the five risk factors considered in the definition of the metabolic syndrome (Expert panel on detection, 2001; Marcuello et al., 2013), that is waist circumference, triglycerides, high density lipoproteins cholesterol, systolic blood pressure and plasma glucose.
次要结局
- Change from baseline in sedentary time(3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.)
- Change from baseline in physical activity self-efficacy questionnaire(3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.)
- Change from baseline in active lifestyle(3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.)
- Change from baseline in dietary habits(3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.)
- Change from baseline in health related quality of life at the end of the intervention(3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.)
- Change from baseline in adiponectin(3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.)
- Change from baseline in health related quality of life(3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.)
- Change from baseline in interleucin-6(3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.)
- Change from baseline in cardiorespiratory fitness(3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.)
- Change from baseline in empowerment(3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.)
- Change from baseline in plasma metabolome(3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.)
研究者
Assumpta Ensenyat
Dr Assumpta Ensenyat (MD, PhD) Exercise Physiology
INEFC-Lleida