Home Based or Traditional Class HIIT in Overweight Women: Effects on Physical Activity, Body Composition and Cardio Respiratory Fitness. A 3-arm Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 主要终点
- Change from Baseline, between and within groups comparison, in percentage of fat mass.
研究概览
简要总结
The present protocol aims to evaluate the effect of two different 16-week High-intensity interval training (HIIT) programs on daily physical activity, body composition, cardiorespiratory fitness, eating behaviour, enjoyment and quality of life in overweight women. Methods: Ninety overweight women (25 - 50 years old) with a body mass index ≥ 25 kg/m2 will be randomly assigned to three groups of 30 participants: a remote home-based HIIT intervention group; a traditional HIIT intervention group; and a non-exercise control group. Both intervention groups will undergo a 16-week progressive HIIT program following the Tabata method. Participants will be assessed at baseline, 4th, 8th, and after 16-week for physical activity, body composition, cardiorespiratory fitness, eating behaviour, enjoyment and quality of life. The study will have a 16-week follow-up post intervention. Results: The participant's enrolment will begin in December 2021, and investigators will anticipate the study completion by the mid of 2022. Conclusions: The HIIT programs might have beneficial effects on daily physical activity, body composition, cardiorespiratory fitness and overall quality of life in overweight women. Moreover, it might be a more enjoyable form of exercise, once it is performed faster than other exercise forms. As a beneficial side effect, these healthy behaviours might have a favourable impact on women's eating behaviours. This study results are expected to add health and well-being professionals' evidence-based knowledge to create strategies and design home-based exercise interventions.
详细描述
Methods Trial design: The study will be a 3-arm Randomized Controlled Trial, in which a similar number of participants will be assigned to three groups: a supervised remote home-based HIIT intervention group (Home-HITT), or a presential a supervised traditional HIIT intervention group (Traditional-HIIT), and a non-exercise control group (CG). The study will have a 32-week duration and will be carried out in Portugal. This RCT will be "single-blind".
This study has been designed according to CONSORT statement for clinical trials. This RCT will apply the "intention-to-treat principle".
Dose rationale: The CG participants will maintain their usual physical and dietary activity. Nevertheless, after the 16-week intervention, participants selected to the CG will have the chance to receive the same 16-week HIIT program. Both interventions will consist of a 16-week exercise program with HIIT with a frequency of 3 days/week. The Home-HIIT group participants will attend HIIT workout sessions supervised by a specialised instructor via a videoconference application, while the Traditional-HIIT group participants will attend HIIT workout sessions supervised in person by the same instructor. Every HIIT workout session will have a 10 minutes' warm-up, followed by an 8/12/16/20 minutes of HIIT training and 5 minutes' cool-down. The intervention will have a type of HIIT program called the Tabata method once it can be performed in home-based programs. Tabata training method has been defined as a HIIT with submaximal effort performed at 80-95% of maximal heart rate.
Tabata method uses eight sets of 20 seconds of exercise bouts separated by 10 seconds rest, in 2 to 5 blocks. It seems that this method is demanding for ordinary adults so it will have four stages of physical adaptation.
Before each session, all participants in the intervention groups will receive a class reminder through a short message service (SMS). After each session, all participants will also receive an SMS with positive reinforcement about their exercise session participation. In order to compensate for possible absences, extra classes will be given. The 16 weeks intervention period was chosen because evidence shows that this period is sufficient to evidence changes in PA levels. Guidelines suggest the need to accumulate 75 min/week of vigorous-intensity PA. Despite the guidelines, this exercise protocol will be characterized by progression in both exercise intensity and volume because the investigators will be handling sedentary and overweight women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
The participants will be randomized and alllocated in one of the three groups (control or experimental HIIT Homebased or experimental HIIT traditional)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female individuals aged between 25 and 50 years old, at the time of selection;
- •have a BMI equal to or greater than 25kg/m2;
- •have the ZOOM application (San Jose, USA) and a 2x2m2 space at home for the practice of HIIT;
- •who present, in their own form, authorized consent to participate in the referred study. Only one person per household will be allowed to be included.
排除标准
- •having any health problem and/or condition that limit the implementation of an HIIT program;
- •taking medication that influences the variables to be studied;
- •being involved in any type of exercise intervention/program;
- •being in pre-menopause or menopause period.
研究组 & 干预措施
Control
No intervention. The control group will maintain their normal physical and dietary activity.
Homebased HIIT
16-week exercise program with HIIT with a frequency of 3 days/week. The Homebased HIIT group participants will attend HIIT workout sessions supervised by a specialised instructor via a videoconference application. This group will have 16 week follow-up.
干预措施: Home based HIIT (Other)
Traditional HIIT
16-week exercise program with HIIT with a frequency of 3 days/week. The Traditional-HIIT group participants will attend presential HIIT workout sessions supervised. This group will have 16 week follow-up.
干预措施: Traditional HIIT (Other)
结局指标
主要结局
Change from Baseline, between and within groups comparison, in percentage of fat mass.
时间窗: 0,4,8,16,32 weeks
It will be assessed % fat mass with a bioimpedance weighing machine electric model Tanita BC601.
Change from Baseline, between and within groups comparison, in bone mass.
时间窗: 0,4,8,16,32 weeks
It will be assessed bone mass with a bioimpedance weighing machine electric model Tanita BC601. The bone mass will be reported in kilograms.
Change from Baseline, between and within groups comparison, in Physical activity.
时间窗: 0,4,8,16,32 weeks
Objectively measured daily physical activity will be assessed through accelerometers.
Change from Baseline, between and within groups comparison, in Cardiorespiratory fitness.
时间窗: 0,4,8,16,32 weeks
To assess VO2max the Chester Step Test will be used.
Change from Baseline, between and within groups comparison, in body mass index (BMI).
时间窗: 0,4,8,16,32 weeks
Weight and height will be measured to the nearest 0.1kg and 0.1cm correspondingly. For BMI, weight in kilograms will be divided by height in squared meters (kg/m2).
Change from Baseline, between and within groups comparison, in muscle mass.
时间窗: 0,4,8,16,32 weeks
It will be assessed muscle mass with a bioimpedance weighing machine electric model Tanita BC601. The muscle mass will be reported in kilograms.
次要结局
- Change from Baseline, between and within groups comparison, in Quality of Life(0,4,8,16,32 weeks)
- Change from Baseline, between and within groups comparison, in Enjoyment(0,4,8,16,32 weeks)
- Change from Baseline, between and within groups comparison, in Eating Behaviour(0,4,8,16,32 weeks)
研究者
João Luis Fernandes do Carmo
Doctoral Student
University of Évora